Careers

Excellent opportunities have arisen to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company. 

 

GW Pharmaceuticals was founded in 1998 and is listed on both the NASDAQ Global Market (GWPH) and AIM, a market of the London Stock Exchange. GW is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes.

 

GW’s vision is to make a positive difference in the lives of patients through the development of a portfolio of cannabinoid prescription medicines in a wide range of therapeutic indications.  Our strategy is to build on our world leading position in the field of cannabinoid science and in the research, development and commercialization of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates.

 

Our lead product is Epidiolex, which is currently in Phase 3 FDA clinical trials being studied in a number of catastrophic childhood-onset epilepsy syndromes.  The product has been granted orphan drug status in those indications.  On 14 March 2016, we announced positive results from the Epidiolex Phase 3 trial in Dravet syndrome. 

 

GW has assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. GW maintains in-house control over all aspects of the cannabinoid product development process. GW also holds GMP manufacturing licences for the manufacture of pharmaceutical products for both clinical trials and commercial purposes

 

For details of GW’s current marketed product and international clinical research programme please refer to information on the company’s website: www.gwpharm.com.

To apply for an advertised position please send your CV together with a covering letter stating your salary expectations to recruitment@gwpharm.com.

 

Unfortunately we are currently unable to consider any speculative applications and so please do not apply for a position unless you believe yourself to be well suited to those advertised.

 

For all other recruitment enquiries please e-mail recruitment@gwpharm.com.

 

Due to the high volume of applications we receive if you do not hear from us within two weeks of applying then unfortunately you have not been successful on this occasion. We do thank you for your interest in working for GW and wish you every success with future applications.

Medical Information Administrator

Cambridge, 6 months FTC

 

An opportunity has arisen for an enthusiastic and motivated individual to join the GW Medical Information department as a Medical Information Administrator. You will be joining a team of Medical Directors and Medical Information Officers/Scientists and will be responsible for a range of administrative duties. You will have excellent organisational skills and be able to manage and prioritise a varied and busy workload and work to deadlines. You will be tactful and discreet when dealing with sensitive and confidential information. Having good attention to detail and a high level of accuracy is also essential.

The main responsibilities of the post include:

  • Contribute to the collection of Medical information related data and inputting of data to the internal management system for audit and competency purposes.
  • Locate information from various relevant sources to be able to process medical information related data.
  • Maintain office data systems and ensure the input of necessary data.
  • Collate, maintain, request and transfer confidential client/ customer records, ensuring they are stored accurately and securely.
  • Track enquiry responses and response timelines to ensure that the Medical Information Officers/Scientists have responded appropriately within agreed timelines.
  • Provide administrative support to the team including photocopying, scanning, filing and archiving reports and other documents.
  • Produce Medical Information related reports, letters and spread sheets where necessary.

Key Attributes

  • Good organisational skills and able to manage and prioritise own workload effectively on a day to day basis
  • Methodical with good attention to detail; can produce accurate documents
  • IT Skills (Outlook, Word, Excel)
  • Excellent communication skills, written and oral
  • Competency in maintaining office data and audit systems
  • Experience of team working
  • Experience within an administrative, customer service setting
  • Knowledge of confidentiality and data protection
  • Flexible approach to work
  • Able to work under pressure and under own initiative without close supervision
  • Reliable work record
  • Motivated 

Location: Cambridge, UK

To apply, please send your C.V and salary requirements to recruitment@gwpharm.com

Pharmacovigilance Associate

 

Permanent, Cambridge

 

About the Role

GW is looking to recruit a full-time permanent staff member to the Pharmacovigilance team which will be based at GW’s offices in Histon, Cambridge.

 

Primary Duties

Working in our global Pharmacovigilance Department the candidate will gain exposure to many different aspects of Pharmacovigilance.  Following an induction to the company and training, the Pharmacovigilance Associate would be responsible for:

  • Case processing including data entry, review and assessment of SAE/AE reports (including narrative writing) from clinical trial and post marketing sources onto our global safety database (ARISg), in accordance with company SOPs and regulatory requirements
  • Assisting with SAE reconciliation.
  • MedDRA coding.
  • Literature review.
  • Using and maintaining the global safety database.
  • Contributing to the ongoing enhancement of Pharmacovigilance processes and writing Standard Operating Procedures.  
  • Supporting the Pharmacovigilance team with the creation and quality control of safety reports in CSRs, DSUR/PSURs, and regulatory dossiers. 

Key attributes/Skills/Education

  • The candidate will ideally be a life sciences graduate and have experience of working in Pharmacovigilance. 
  • Competent with medical terminology
  • Excellent communication abilities and possess good IT skills.
  • Previous use of a safety database (preferably ARISg web based) is required.
  • A high standard of organisation, narrative writing and impeccable attention to detail is essential. 

This is an excellent opportunity for a candidate seeking to broaden their safety knowledge in both a clinical trial and post-marketing setting and to be part of a progressive department.

To apply please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com

Automation Engineer

Permanent, South East UK

 

Role

  • To lead and take ownership of all the manufacturing automation and control systems on site.
  • To support the automation and control systems through their lifecycle (development of URs and FDs, through to installation, commissioning, qualification, validation and system maintenance).

 

Duties

  • To develop and support automated systems to ensure systems are operational and appropriate for use by production. Systems to include all Process Control Systems, Batch Historians, and Independent Monitoring System (IMS).
  • To provide technical knowledge on automation projects, plant modifications and continuous improvement projects.
  • To ensure that all manufacturing and related activities associated with automated control systems are performed in accordance with all relevant internal/external quality and safety standards.
  • Act as Subject Matter Expert (SME) to all external regulatory bodies, marketing partners and suppliers for all Production/manufacturing automated systems.
  • To develop short, medium and long term improvement plans for implementation within the automated systems.  Take responsibility for investigating and introducing new engineering technologies and strategies.
  • To develop the skills, and knowledge of production, engineering, technical staff and work teams on Automation and Control Systems by training and mentoring.
  • Facilitate interface between automated system and centralised ERP system.
  • Perform validation activities in collaboration with Computer Systems Validation (CSV) team

 

Knowledge, Skills and Experience Required:

  • A background in Automation and Control is essential.
  • Experience with PLC’s and SCADA control systems is a key requirement.
  • Will have a demonstrated track record with relevant experience working in a regulated industry preferably in Pharmaceuticals. Working in a cGMP or regulated industry would be preferable.
  • Knowledge of Rockwell Automation ControlLogix and FactoryTalk technology would be advantageous.
  • Qualification to degree or equivalent standard would be an advantage.
  • Project Management experience.
  • Direct involvement in regulatory audits (cGMP and EHS).
  • Able to form long term relationships with key support groups; QA, engineering, CSV group and senior managers across the site.
  • Interacts with other functions and sites regarding broader projects.
  • Good oral, written and presentation skills essential.

This is a full time, permanent position.

To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com

QC Team Leader


South East, UK

 

The Role

 

Reporting to the QC Manager, the QC Team Leader will manage the day to day work of a team of analysts.  The role will include scheduling work, checking & reporting of results, release of products, qualification of equipment and/or methods, and any other customer requirements for the areas of responsibility assigned. 

 

Key Responsibilities

  • To supervise, train, and mentor QC team members and ensure that they work to cGMP at all times. 
  • Planning, prioritising, and managing the QC analysis for the areas of responsibility by co-ordinating with other QC Team Leaders, QC Manager, and other departments (customers)
  • Ensures that all analytical operations are performed in accordance with current cGMP regulations
  • Participates in the continuous trending, communication, and review of batch data
  • Checking of analytical data and results, ensuring that they are clear, correct and in compliance with procedures, specification limits and cGMP requirements.
  • Leading and documenting laboratory OOS, OOE and OOT investigations, and deviation investigations, identifying the root causes of problems and introducing effective corrective and preventative actions
  • Qualification of Laboratory instruments and validation of analytical methods
  • Creating and updating documents in accordance with cGMP and company procedures

 

Essential Skills

  • Educated to degree level in chemistry (or related science based subject) as a minimum
  • Training in, and experience of, leading a team in a pharmaceutical or other regulated laboratory
  • High level of knowledge and understanding of cGMP regulations
  • Experience in analytical method validation, instrument qualification, and CSV requirements
  • Knowledge and understanding of data integrity requirements
  • High level of knowledge and experience of QC analytical testing and the use, and troubleshooting of, analytical instrumentation
  • Knowledge of stability testing and associated guidelines
  • Experience of Pharmacopoeial testing and the use of Pharmacopoeias
  • Good communication, presentation, coaching/training, and team working skills
  • Computer literate
  • High level of numeracy
  • Excellent attention to detail and ‘concern for quality’
  • Develops and maintains positive working relationships with others
  • Demonstrates a ‘can do’ approach

 

Desirable:

  • Experience of using the Empower CDS
  • Experience in the use of and data interpretation from GC-MS and LC-MS
  • Knowledge and experience of testing natural products in a cGMP environment

 

Location: South East, UK

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Warehouse Operative

 

South East, UK

Permanent

 

The Role

To receive, store and distribute materials and products and dispatch of product and raw materials to customers and partners

 

Key Responsibilities

  • Receiving of raw materials from suppliers
  • Booking In of materials to be stored within the warehouse
  • Picking and delivery of materials to internal customers
  • Receiving of finished product and storing in appropriate storage locations
  • Maintenance of stock records
  • Raw material and finished goods cycle counting
  • Support six monthly stock checks
  • Provide Supply Chain Department support as required
  • Assist with commercial shipments to marketing partners.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job
  • Supporting both domestic and international product shipments
  • Support for out of hours call outs for Supply Chain plant alarms

 

Essential Skills

  • Experience in a similar Supply Chain position
  • Knowledge of a broad-base of supply chain functions and disciplines
  • Pharmaceutical industry experience desirable
  • Fork Truck Licence
  • Self-motivation and exceptional commitment
  • Excellent interpersonal and communication skills
  • Attention to detail and delivery of accurate data
  • Knowledge of IT systems and software including ERP (Enterprise Resource Planning) software and MS Office software especially Excel

 

Location: South East, UK 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

BDP Process Technician

 

Permanent

South East, UK

 

The Role

 

To work as part of a Team to ensure the department delivers the product to the customer on time and in full. This covers the manufacture and filling of the bulk solution for Supply Chain and packing the labelled filled vials for the various markets supplied by GW Pharmaceuticals marketing partners.

 

Key Responsibilities

Quality is a primary focus to ensure all aspects of cGMP are met and product quality is not compromised. The workload is varied with the core areas of responsibility listed below:

  • Ensure delivery against schedule, for all BDS/BDP production batches
  • To work with the BDS/BDP Management to ensure that all personnel training, investigation and deviation actions, critical documentation and audit actions are completed on time
  • Enforce, maintain and adhere to cGMP and H&S knowledge applicable to this role
  • Where required help to ensure the successful implementation of approved projects and business plans within the BDS/BDP area and wider Production department
  • Ensure all BDS/BDP batch documentation have been processed in accordance with cGMP and current GW procedures
  • Maintain stock levels including stock cupboard checks and stock ordering to supply BDS/BDP
  • Perform routine micro testing in the CMS
  • Weekly/Specialised clean in all areas

 

Essential Skills

  • Experience in a regulated production environment within the pharmaceutical or related industry.
  • Understanding of GMP.
  • Experience of various filling and packaging machinery.

Skills:

  • Good working knowledge of Microsoft Packages i.e. Word, Excel, PowerPoint
  • Good interpersonal skills
  • High level of numeracy
  • Good communication skills including written and presentational
  • Excellent attention to detail

Location: South East, UK 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

 

Clinical Coordination Manager

 

Carlsbad, CA

 

About the role:

The Clinical Coordination Manager will be responsible for the administration of clinical projects in the United States in support of Clinical Operations objectives and the global Clinical Coordination Department.

 

Responsibilities:

  • Coordination and tracking of clinical projects.
  • Provide support to Clinical Operations Managers (COMs), Clinical Project Managers (CPMs) and Clinical Research Associates (CRAs) during the life of the clinical trial.
  • Set up and maintenance of paper and electronic trial filing systems.
  • Assist in development of Clinical Coordination systems and procedures.
  • Line management of one or more CPA or other CCD staff
  • Implementation and maintenance of logs, which may include the following; trial feasibility, trial tracking, monitoring visit reports and equipment.
  • Development and maintenance of trial progress logs to monitor subject recruitment and CRF monitoring.
  • Ensure log is updated throughout the working day so current recruitment figures are available.
  • Coordination of submissions/responses and tracking approvals and progress.
  • Preparation of Clinical Trial Agreements and Financial Agreements in liaison with the Contracts Coordinator.
  • Preparation of site specific trial documentation, ensuring that accurate version control is applied.
  • Attends CRA meetings, project team meetings and trial specific meetings and reports on trial progress as required.
  • Update Central Laboratories, Interactive Voice Response System (IVRS), Electronic Data Capture (EDC) and other service providers with site contact information (as requested).
  • Set-up and maintain Trial Master Files in accordance with company Standard Operating Procedures (SOPs) and International Conference on Harmonization (ICH) GCP.
  • Ensure electronic trial filing is completed.
  • Write and review Clinical Coordination SOPs as required.

Requirements:

  • Experience in the pharmaceutical industry.
  • Good interpersonal skills – including oral and written communication skills.
  • Project management skills.
  • Able to work in a team and as an individual.
  • Knowledge of relevant regulatory guidelines and legislation.
  • Working knowledge of MS Outlook, Word, Excel and PowerPoint.
  • Direct experience of line management, or of mentorship.

Please send your C.V and salary expectations to usrecruitment@gwpharm.com

Human Resources Business Partner

 

Carlsbad, CA

 

About the role:

This role will be the human resource partner to GW’s US Clinical, Regulatory, and Quality functions.  This includes partnering with leaders and employees to drive achievement of organization objectives.  This individual will also play a critical role in building out a strong HR foundation in our rapid growing US organization including the design and implementation of policies, processes, and systems.  The successful candidate will have a strong HR generalist background including experience driving change, shaping culture, developing talent, managing projects, and managing governance, risk, and compliance.

 

Responsibilities:

 

Recruitment and Employment:
Attract, motivate, and retain a diverse workforce that delivers results.  Drive recruitment strategies and processes including review and approval of requisitions, participation on interview panels, selection of candidates, and execution of the new employee on-boarding activities.  Manage full employee life cycle from onboarding to separation.

 

Employee Relations:

Manage employee relations to enhance workforce performance and productivity.  Identify and address people and organizational risk.  Recommend and implement strategies for maintaining a positive work environment.

 

Culture & Engagement:

Establish culture and drive employee engagement by:  analyzing trends and developing engagement strategies; ensuring appropriate employee value proposition; partnering with leaders to deliver timely and effective communications; influencing operating mechanisms to ensure alignment with strategic growth plans.

 

Talent Management:

Build manager capability.  Provide coaching and feedback to managers on talent management activities including performance management, training and development, organizational capability assessment, strategy and planning.  Facilitate annual calibration and compensation planning processes, prepare for talent reviews, and provide development opportunities. 

 

Change Management:

Develop and implement change initiatives to drive organizational alignment, effectiveness, and efficiency.  Develop, communicate and implement initiatives and programs that minimize organization disruption and maximize employee engagement. 

 

Project Management:

Apply sound project management, problem solving and process improvement tools or methodologies to achieve strategic and tactical plans. Have an organized and systematic approach to accomplishing project deliverables. Coordinate written and oral communication for projects and change management while working with colleagues and/or external consultants regarding project deliverables, roles, resource requirements, timelines and costs. Develop appropriate qualitative and quantitative metrics to measure the effectiveness of the project.

 

Governance, Risk & Compliance:

Ensure compliance with all state and federal statutes and regulations including but not limited to applicable wage and hour laws, and regulations related to FMLA, EEO and ADA.  Partner with EHS to actively manage employee-related programs.  

 

Requirements:

  • Bachelor’s Degree in Human Resources, Business Administration, Industrial/Organizational Psychology or other related discipline or equivalent knowledge and experience required.  Professional certification in Human Resources and/or graduate coursework preferred.
  • Relevant professional level human resources experience
  • Previous pharmaceutical experience highly preferred.
  • The successful candidate will be enthusiastic, possess a learning orientation and the ability to work in a decentralized environment.
  • Strong communication and change management skills required, in addition to ability to build strong relationships both vertically and horizontally.
  • Incumbent must be able to escalate difficult issues and make tough decisions.
  • Travel is required
  • May perform other related duties as required and /or assigned 

Please send your C.V and salary expectations to usrecruitment@gwpharm.com

CTS Programme Manager

 

South East, UK

Permanent

 

The Role

The role is to be the department point of contact and provide both operational and strategic support for clinical trial programmes at GW as designated by the Head of CTS. This role covers a large scope from the planning stages, through the operational activities and drug supply management during the lifecycle of the trial. This role is also required to provide forecasting and reporting as requested by the Head of CTS and the relevant clinical teams.

 

Key Responsibilities

  • To establish an excellent working relationship with the clinical team in order to fully understand the needs for the trial and the team.
  • To guide the clinical team in the design of the packaging and labelling to ensure the appropriate flexibility and cost effective options are explored and an agreed decision is made.
  • To prepare study specification files, packaging documentation and labels for all IMP to be used in GW Pharma / Research clinical studies.
  • Work to and maintain a high level of Good Manufacturing Practice (GMP) according to MHRA and FDA Guidelines.
  • To keep a thorough knowledge and strict policy of working to GW Pharma Ltd SOPs and create, contribute to and review new and existing GW SOPs, in order to maintain a GMP environment.
  • To forecast and obtain the materials required to meet study supply requirements by liaising with the clinical coordination department, supply chain department and external suppliers.
  • To supply IMP to study sites against agreed timelines by coordinating with the Clinical Coordination department, worldwide couriers, distribution warehouses and study sites.
  • To identify competing priorities and raise any supply constraints to the Head of CTS.
  • Accountable for the delivery of the designated clinical trial material to the agreed timelines.
  • Accountable for all IMP produced, within the designated clinical trial, and distributed at end of a study
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job. 

Essential Skills & Knowledge

Knowledge:

  • An excellent knowledge of Good Manufacturing Practice (GMP) and GxP.
  • Knowledge of the ICH Guidelines, in particular Annex 13.
  • Knowledge of requirements for the clinical labelling
  • Good Project management skills.
  • Knowledge of Vendor Depot Management.
  • Understanding of Interactive Voice Response software
  • Knowledge of Green belt continuous improvement principles
  • Knowledge of controlled drug restrictions and requirements. 

Experience:

  • An established track record of working within a GMP environment is essential.
  • Experience as a project manager
  • Experience of continuous improvement practice
  • Experience working with controlled drug movement. 

Skills

  • Excellent knowledge of Microsoft Office, including Excel
  • High level of numeracy
  • Excellent communication skills both written and presentational
  • Excellent attention to detail 

Desirable

  • Experience within the Pharma Clinical Trial field 

Location: South East, UK

To apply please send your CV with salary expectations to recruitment@gwpharm.com

CTS Distribution Team Lead

 

South East, UK

Permanent

 

The Role

To manage specific functions of the Clinical Trial Supplies Department, as identified below ensuring effective and efficient delivery, in a timely manner and in accordance with Good Manufacturing Practice, Good Clinical Practice and Good Distribution Practice.

 

Key Responsibilities

  • Recognised as Import / Export expert within function
  • Accountable for the process and execution of Depot Set up and Management
  • Provide oversight of the Trial Master File essential record management
  • Accountable for maintaining cGxP and H&S knowledge applicable to the job as required.
  • To be accountable for the compliant shipment of IMP and associated items, dependant on product, presentation and GDP responsibilities.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job. 

Essential Skills & Knowledge

Knowledge

  • Specific experience within a GMP clinical trial supply environment.
  • Good knowledge of clinical trial process.
  • Project planning 

Experience:

  • Shipping  cold chain, ambient and controlled drug shipping
  • Shipment tracking and maintaining audit trail of IMP and ancillary items.
  • Liaising with couriers and third party depot communications
  • Experience working in a Pharmaceutical or other regulated industry is essential.
  • Proven experience of people management
  • Previous experience of shipping Controlled Drug and restrictive storage conditions
  • Experience of Import and Export; obtaining licenses and shipping documentation 

Skills

  • A good working knowledge of Excel
  • High level of numeracy
  • Communication skills including written and presentational
  • Excellent attention to detail
  • Excellent knowledge of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) & Good Distribution Practice (GDP)
  • Experienced in juggling the demands of projects and people 

Location: South East, UK

To apply please send your CV with salary expectations to recruitment@gwpharm.com.

CTS Distribution Specialist

 

South East, UK

Permanent

 

The Role

To coordinate specific functions of the Clinical Trial Supplies Department, as identified below ensuring effective and efficient delivery, in a timely manner and in accordance with Good Manufacturing Practice, Good Clinical Practice and Good Distribution Practice.

.

Key Responsibilities

  • To be one of the Subject Matter Experts in Import and Export activities for the department.
  • Depot Set up and Management
  • To act as a contact for new depot requirements for clinical trial studies.
  • Prepare Clinical Trial consignment documentation to GxP standards as required.
  • The role holder is responsible for the preparation of the physical consignment.
  • Contribute to Trial Master File process
  • Coordination of Investigator Initiated Trial’s
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job 

Essential Skills & Knowledge

Knowledge:

  • Good knowledge of clinical trial process.
  • Project planning
  • Previous experience of shipping Controlled Drug and restrictive storage conditions  

Experience:

  • Experience working in a Pharmaceutical or other regulated industry is essential.
  • Specific experience within a GMP clinical trial supply environment.
  • Experience of Import and Export; obtaining licenses and shipping documentation
  • Excellent communication skills, both written and oral
  • Experience of shipping  cold chain, ambient and controlled drug shipping
  • Experience of shipment tracking and maintaining audit trail of IMP and ancillary items.
  • Liaising with couriers and third party depot communications

Skills:

  • A good working knowledge of Excel
  • High level of numeracy
  • Communication skills including written and presentational
  • Excellent attention to detail
  • Excellent knowledge of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) & Good Distribution Practice (GDP)

 

Location: South East, UK

To apply please send your CV with salary expectations to recruitment@gwpharm.com

CTS Archive Administrator

South East, UK

 18 Month FTC

 

The Role

To coordinate the collection of key essential documents, from the Clinical Trial Supplies Department (CTS), for the purpose of the Trial Master File (TMF) compilation and departmental archive. This role will maintain and manage the document archive within CTS and prepare key essential documentation for transfer to the company archivist.

.

Key Responsibilities

  • To identify and collate key essential documentation required for the TMF for the CTS department
  • To maintain, where appropriate, the TMF content for current active GW clinical trials.
  • To review for completeness (according to the current document practice within CTS and the GW company retention procedure) all documents identified as part of the TMF.
  • Where anomalies are identified to ensure these are raised as a concern and followed through to completion.
  • To ensure that documents required to be retained and archived in more than one place are copied and managed appropriately to ensure clear visibility and location of original content.
  • To maintain the CTS document archive.
  • To work with external archiving vendors as appropriate to ensure clear visibility of the location of documents.
  • To contribute to the process of TMF and CTS archiving as part of any process improvements.  
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job. 

Essential Skills & Knowledge

Knowledge:

  • Archivist qualification is not essential however a good standard of education is desirable
  • An understanding of document classification and indexing is desirable
  • A good knowledge of archiving principles and accuracy

 Experience

  • It is not essential to have worked previously within the Pharmaceutical industry but relevant experience in another regulated industry desirable.

Skills

  • Attention to detail is essential within this role
  • Good communication skills both written and verbal are required
  • Ability to work independently and within teams is desirable 

 

Location: South East, UK

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Engineering Stock Controller

 

South East, UK

Permanent

 

The Role

 

This is a key position within the company requiring stock control of an Engineering Stores within a pharmaceutical environment.  There is a need to ensure all critical spares are available when required and to check that new spares meet specification before being put onto the system.

Quality is a primary focus to ensure that patients receive a safe, effective and quality assured product.  This requires working to the principles of Good Manufacturing Practice (GMP).  The department is subject to regular visits by senior management, external pharmaceutical companies and regulatory authorities.  In order to achieve the high standards required, accurate stock management of spare parts is an integral part of the Engineering function.

The ideal person would be computer literate (Word & Excel) and have experience working in an electronic stock controlled stores system within the pharmaceutical or food environment, experience of an electronic maintenance system with stock management function would be a benefit.

 

Key Responsibilities

  • Issue and re-stock items taken from the stores including raising PO’s for items
  • Inspect incoming spares to ensure they conform to a specification (if applicable) or meet the requirements of the PO
  • Monitoring stock levels and ensuring incoming parts are accurately stored
  • Carry out stock takes at agreed intervals and assist colleagues with stock related queries
  • Ensure tools which are held in the central store are booked out and returned in a timely manner, carry out stock checks to the tools which are issued directly to the Engineers.
  • Monitor usage levels and offer suggestions to ensure we operate a cost effective system
  • To act as a craft assistant to one of the Engineers when 2-person working is required
  • To provide back up to Engineering Admin in times of holidays and sickness.

 

Essential Skills

 

Knowledge:

  • GCSE in Maths and English
  • Good IT skills including Word and Excel

 

Experience:

  • Stores and stock controller experience working in a Pharma or Engineering environment or similar 

Skills:

  • Good communication skills including written
  • Attention to detail
  • Good organisational skills with Microsoft Outlook experience

 

Desirable Skills

  • Previous pharmaceutical experience
  • Stock controlling or stores experience in Pharma or ISO9000 environment.

 

Location: South East, UK

 

To apply please send your C.V and salary expectations to recruitment@gwpharm.com

Maintenance Technician

 

South East, UK

Permanent

 

Job Purpose

 

This expanding pharmaceutical company is looking for a Maintenance Engineer to join its Engineering Department based in South East England.

The role is a key position within the company requiring mechanical maintenance skills appropriate to a pharmaceutical manufacturing and packaging environment.

Quality is a primary focus to ensure that patients receive a safe, effective and quality assured product. This requires working to the principles of Good Manufacturing Practice (GMP). In order to achieve the high standards required, documented maintenance and calibration is an integral part of the daily routine.

You will be required to carry out mechanical maintenance tasks and to contribute to the efficient running of the Engineering Department.

 

Key Responsibilities

  • Deliver maintenance tasks on time and to a high standard while maintaining compliance with equipment validation where applicable.
  • Carry out PPM tasks to a variety of equipment including bottle filling and packaging machines, API process equipment, AHU’s and utilities.
  • Complete documentation to GMP standards.
  • Work efficiently as part of a team.
  • As part of a team to prepare and perform Installation Qualification (IQ) and Operational Qualification (OQ) of new plant and equipment.
  • Provide technical support and Operator training where necessary.
  • Provide and keep up-to-date SOP’s for the Engineering Department.
  • Ensure that all equipment safety testing such as pressure/pressure relief is kept current and certified.
  • Supervision of contractors when required.
  • You will report to the Engineering Team Leader
  • The nature of the work requires team members to be flexible with regards to working time to ensure that they are available to support production processes should they overrun.

Key attributes/Skills/education

  • The ideal candidate for this position will be a qualified mechanical or M/E technician with C&G trade certification and have proven pharmaceutical (GMP) experience, preferably in the manufacturing environment. 
  • As a minimum the job holder should have worked under an ISO9000 quality environment and possess working knowledge of Microsoft Office applications.
  • Experience in a pharmaceutical API or packaging facility is an advantage.

 

Location: South East, UK

To apply please send your C.V and salary expectations to recruitment@gwpharm.com

Document Control Assistant

Permanent

South East, UK

 

The Role

A Document Control Assistant is required to join the Document Control Group.  You will be responsible for the issuing of documents and ensure that documents are stored appropriately in accordance with the company Quality System.

 

Key Responsibilities

  • Issuing of controlled documents to file holders
  • Maintaining of QA Excel™ logs
  • Maintaining of site document archive
  • Maintaining site signature log
  • Updating of item code database
  • Filing of master documents
  • Ordering of stationery
  • Action External Post
  • Maintaining SharePoint eSOP site
  • Scanning and photocopying as required

Essential Skills

  • An organised approach to documentation
  • Attention to detail
  • Ability to prioritise and complete tasks
  • Educated to GCSE level or above
  • Good communication skills (written and oral)
  • Microsoft Office experience

Desirable Skills

  • Experience of using SharePoint
  • Advanced MS Office skills
  • Experience of archiving documents

 

Location: South East, UK

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Clinical Compliance Officer

 

Cambridge, UK

FTC - 12 months

 

The Role

Process improvement is a key focus within GW Clinical Operations, and the Clinical Compliance Officer is empowered to identify, develop and drive the implementation of new ways of working. They will have a solid understanding of clinical trials, and the ability to critically evaluate, refine and communicate processes.

 

Key Responsibilities

  • Drive Corrective and Preventative Action (CAPA) development and resolution across Clinical Operations
  • Recognise, develop and implement cross-functional process improvements
  • Support preparation for audits and inspections
  • Drive SOP updates and implementation
  • Establish system/process training needs, develop materials and deliver training
  • Promote compliance with regulations, SOPs & guidelines

 

Essential Skills

  • Substantial experience working in clinical trials environment
  • Knowledge of GCP and current regulations governing clinical trial conduct
  • Degree in Biological Science/Nursing Qualification or equivalent - preferable
  • Experience of inspections and audits
  • Ability to influence/motivate colleagues, and to promote effective team working
  • Flexible and adaptable to a fast-changing environment
  • Strong communication skills (written and oral)
  • SOP writing
  • Root cause analysis and CAPA development
  • Computer literate in Microsoft packages
  • Excellent time management and organisational skills

Location: Cambridge, UK

To apply please send your CV and cover letter with salary expectations to recruitment@gwpharm.com

BDS Process Technician, South East, UK

 

Permanent

 

The Role

The BDS Process Technician is responsible for processing Botanical Drug Substance (BDS) using a series of well-defined and documented manufacturing processes/procedures. Whilst being in compliance with Health and Safety (H&S) and current Good Manufacturing Practices (cGMP) requirements.

The BDS Process Technician will also have the responsibility of being the back-up for the BDS Production Line Lead in their absence. Working hours are 08:00 – 16:30.

 

Key Responsibilities

  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.
  • Process manufacture of BDS.
  • In the absence of the BDS Production Line Lead, provide day-to-day leadership, support and direction to the team, to include dealing with routine staffing matters occurring within their team, referring issues up the line as required.
  • In the absence of the BDS Production Line Lead, Compiling the Home Office returns and liaising with other departments to ensure that the figures are correct.
  • Recording of manufacturing/process conditions in batch documentation and equipment/area logbooks.
  • Complete area/equipment cleaning procedures to high standards as illustrated in cGMP practices.
  • Completing/reviewing deviations and change controls that may occur during the running of BDS Production Departments.
  • Authoring and reviewing of batch documentation and Standard Operating Procedures (SOP).
  • The Job Holder maybe called upon to provide cover for other internal departments, when the BDS Production schedule allows.
  • The Production Department is subject to regular visits by senior management, external bodies and regulatory authorities. The BDS Process Technician will be called upon to conduct tours of the BDS Production Facility.
  • Identifying areas for improvement and implementing these improvements, where applicable across all BDS Production processes/working practices.
  • Training of –other Technicians on new processes/changes to manufacturing techniques.
  • Act as key Point of Contact (POC) for all key stakeholders (groups), in the absence of the Production Manager/Extraction Manager/BDS Team Leader.
  • Completing additional tasks assigned by Production management that are outside the core duties described above 

Essential Skill 

  • Experience gained in a regulated production environment, ideally within the pharmaceutical/chemical or food industry.
  • Good level of numeracy.
  • Good communication skills including written.
  • A good working knowledge of standard Microsoft packages, i.e. Excel and Word.
  • The ability to work on own or in a small team environment.
  • Excellent attention to detail.
  • Develops and maintains positive working relationships with key stakeholder groups, both internal and external.
  • Prepared to challenge the norm and look for areas of improvement, share own ideas and information.
  • Good Team worker assists colleagues as and when required.
  • Demonstrates a ‘can do’ attitude. 

Desirable

  • Ideally hold qualifications gained in the Pharmaceutical industry i.e. NVQ’s, or similar. 

Location: South East, UK

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Horticultural Technician - South East UK

 

Permanent

 

The Role

To be part of the horticultural team involved with the propagation, maintenance, harvest and processing of research and commercial crops. The candidate must work within a GxP environment and operate within the bounds of standard operating procedures.

 

Key Responsibilities

  • Planting of seed
  • Preparation of cuttings
  • Planting of crops
  • Watering
  • Application of bio control
  • Crop monitoring
  • Harvest of crop
  • Processing and packing
  • Documentation and audit
  • Weekend duties
  • Maintenance and cleaning as required
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job
  • Carries out their work in a way that will not adversely affect their own, or others’, health, safety and security or the environment and reports any shortcomings in GW arrangements

 

Essential Skills

  • Experience of team working
  • Experience of a quality controlled environment within the workplace
  • Can demonstrate a practical interest and knowledge of basic horticulture
  • Flexible aptitude for lone or team working
  • Excellent attention to detail
  • Good level of computer literacy and competent use of Excel spreadsheets

 

Desirable Skills

  • Develops and maintains positive working relationships with others
  • Shares ideas and information
  • Assists colleagues as and when required
  • Demonstrates a ‘can do’ approach
  • Open and honest with reporting of faults, mistakes or errors noted within the work environment
  • Folk Lift Truck License
  • First Aid Training
  • Health and Safety representative and Training

 

Location: South East, UK

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Regional MSL Manager, US - Various locations accepted - Large airport access required

 

The role

The Regional Medical Science Liaison (MSL) Manager will lead a regional field-based MSL team, functioning as an extension of the US Medical Affairs organization. Working with Medical Affairs leadership, the Regional Manager will provide strategic and operational support for executing the MSL tactics as well as ongoing territory development. This position will involve oversight of key MSL programs regionally and nationally as necessary. The strategic areas of focus include scientific exchange, health-care decision maker education, and research. MSLs are responsible for developing and enhancing professional relationships with medical thought leaders involved in various phases of product development, and the Regional Manager will be critical to successfully meeting these objectives at the individual and field-team levels.

 

Key Responsibilities

 

  • Develop and execute field business plans based on the US Medical Affairs strategic plan
  • Hire and train MSL team members 
  • Structure and lead a regional team of MSLs to provide innovative and optimized medical leadership during a US product launch
  • Interpret and translate national strategies into MSL territory business plans that include development and engagement with regional opinion leaders. Opinion leader development includes appropriate engagement with disease experts in research, as speakers, as advisors and other disease related activities
  • Manage and develop a regional team of MSLs including hiring, field training, evaluation, motivation, and disciplinary activities in alignment with GW’s corporate strategies and objectives. Provide strong leadership to motivate MSLs and achieve excellent results that align with corporate goals and culture
  • Ensure that all interactions and activities in the region comply with GW business guidance, policies, and SOPs, FDA, and PhRMA guidelines/policies
  • Maintain relationships with a small list of national level opinion leaders within their region to enhance engagement for strategic initiatives
  • Guide and assist the MSLs in the coordination of opinion leader interactions across the region and with other external stakeholders as necessary
  • Develop and maintain productive and appropriate relationships with individuals across the organization to include commercial and clinical development
  • Appropriately partner with the commercial field team and corporate team to provide necessary and appropriate medical resources in the region and corresponding districts
  • Clearly communicate national, regional, and territory plans and tactics; define, clarify and manage regional team priorities; actively support the regional team within their scope of responsibility by being their advocate and spokesperson; promote collaboration within the team, across work groups and with customers
  • Collaborate within medical affairs to appropriately respond to unsolicited requests for pipeline or off-label information
  • Represent the MSL function on US medical affairs teams as necessary

 

Requirements:

  • Master’s level scientific education required. MD, DO, PharmD, or PhD strongly preferred
  • Relevant industry experience; people management experience is required; product launch experience highly desired
  • Experience building MSL business plans based on medical affairs strategy is required
  • Experience building an MSL team for a new organization is preferred
  • Field experience as an MSL is required
  • Experience and expertise in the field of epilepsy is preferred; Neurology therapeutic area experience is required
  • Excellent communication, presentation and time management skills are required; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization
  • Strong understanding of US legal, regulatory, and compliance regulations and guidelines is required
  • Strong capabilities working with digital platforms and tools are required
  • Ability to travel at least 50% of the time

 

Location: US, Various locations accepted – Large airport access required

 

 To apply please send your CV with salary expectations to usrecruitment@gwpharm.com

Senior Clinical Quality Assurance Auditors – Cambridge or Field Based –12 & 18 month FTC

 

The Role

  • To provide objective assurance to GW management through the preparation, performance, reporting and follow-up of independent clinical quality assurance audits, that clinical trials are conducted in compliance with the relevant GxP guidelines, regulations and GW or other applicable standard operating procedures (SOPs).
  • To support operational staff through advice and training related to specific area of GxP, regulations and process knowledge and to identify process improvement opportunities through SOP review and audit activities.

 

Key Responsibilities

  • To assist the Clinical Quality Assurance (CQA) Manager with the set-up, implementation and conduct of the CQA audit programme.
  • To act as audit programme lead for an assigned audit programme.
  • To report audit findings to the CQA Manager and the client groups in accordance with company SOPs.
  • To assess the appropriateness and monitor the implementation of corrective and preventative actions (CAPA) arising from audits and track to satisfactory closure.
  • To assist with the preparation for inspection readiness and hosting of regulatory inspections and external party audits of GW (e.g. partners).
  • To assist with the preparation for GCP inspections conducted by national and international regulatory authorities and other external bodies such as marketing partners. 
  • To assist the CQA Manager with the promotion of quality awareness among company personnel and assist with the development and maintenance of company GxPs and quality standards by means of a training, review, advice and guidance service.
  • To identify and communicate quality improvements in GxP activities.
  • To provide day to day support, mentoring and training to other members of CQA in GCP audit techniques, with the production and implementation of training programmes and assessing competency where appropriate.
  • To maintain current GxP and Health & Safety knowledge applicable to the job.

 

Essential Skills

Knowledge

  • A Bachelor’s degree in a scientific discipline or nursing degree
  • ICH-GCP international regulations and guidance, with the ability to apply this knowledge to resolve day-to-day issues.

 

Experience

  • Previous GCP auditing experience from working in a Pharmaceutical company or other regulated industry.

 

Skills

  • Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and to work effectively in a multi-disciplinary team.
  • Good organisational skills, with the ability to multi-task, including the ability to work independently or as part of a team, to agreed deadlines.
  • Excellent attention to detail and the ability to identify the root cause of problems.
  • Competency in Microsoft office, Word, Excel, Powerpoint
  • High level of numeracy

 

Desirable Skills

Knowledge

  • Quality Assurance / Quality Management qualifications.
  • GxP international regulations and guidance, with the ability to apply this knowledge to resolve day-to-day issues.
  • European, United States and UK regulatory requirements.
  • Pharmaceutical regulatory standards in clinical research and international regulatory requirements for product registration.

 

Experience

  • GCP auditing experience working in a healthcare company or CRO, with demonstrated knowledge and experience of audit and inspection techniques
  • Experience of auditing Pharmacovigilance activities

 

Skills

  • Competency in use of electronic systems for management and tracking of audits, audit reports, CAPAs.

Location: Cambridge or Field based

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Senior Manager/Associate Director of Regulatory Affairs – US

 

The Role

To write, submit, and maintain US applications (INDs, ODAs, and NDAs) for products in development and approved products according to ICH and FDA regulations.

 

Key Responsibilities

  • Plans, coordinates and participates in writing, preparation, assembly, and maintenance of US applications to regulatory authorities
  • Creates and manages submissions timelines and provides operational guidance and regulatory advice to submission teams
  • Builds and maintains relationships with other functions within GW
  • Maintains Regulatory Systems and provides administrative support
  • Other duties as required 

 

Essential Skills

  • Bachelor of Arts/Science degree in a relevant discipline
  • Extensive regulatory strategy and project management experience
  • Extensive experience and interactions with FDA on drug development programs, including organizing and leading meetings with FDA
  • Knowledge of FDA and ICH guidelines and up to date training on SOPs 

 

Desirable

  • Additional higher educational qualification, such as a Master’s degree or PhD. 

 

Location:  North Carolina, US 

 

To apply please send your CV with salary expectations to usrecruitment@gwpharm.com 

Clinical Research Associate – US (various locations)

 

The Role

Responsible for the day to day activities including set up, monitoring and completion of clinical trials in accordance with GW SOPs, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and relevant local and international regulatory guidelines.

 

Key Responsibilities

  • Ensures the integrity of clinical data and adherence to applicable regulatory, protocol and Company guidelines.
  • Ensures the rights, safety and wellbeing of clinical trial subjects is maintained.
  • In accordance with GW SOPs, performs site management activities including:
    • site evaluation visits
    • site initiation visits
    • monitoring visits
    • closeout visits
  • Collaborates with the Core Project Team to drive subject recruitment
  • Establishes and maintains regular contact with Investigators, vendors and trial sites to ensure compliance with applicable regulations and the protocol.
  • Is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

Essential Skills

  • BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification and experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry.
  • Experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
  • Good knowledge of relevant GW SOP’s, ICH-GCP, The US Food and Drug Administration FDA Code of Federal Regulations Title 21 – Food & Drugs Good Clinical Practice Parts: 11, 50, 54, 56, 312 and 314  and other regulatory guidelines, as applicable.
  • Fluent in English and in the relevant native language.
  • Possess strong verbal and written communication, interpersonal and organisational skills.
  • Have a high degree of accuracy and attention to detail with a proven track record for ensuring quality data and good site management.
  • Ability to travel to sites and be available for domestic and international travel including overnight stays, as required.
  • Able to use initiative and problem solve.
  • Flexible and adaptive approach to work.
  • Able to work in a team and as an individual.
  • Ability to identify issues and resolve appropriately with guidance.
  • Ability to process visit reports in a timely manner to an acceptable quality. 

 

Location – US, various locations 

 

To apply please send your CV with salary expectations to usrecruitment@gwpharm.com

 

 

GW is fully committed to achieving equality of opportunity in all its employment practices, policies and procedures irrespective of their race, ethnic origin, religion, colour, age, gender, sexual orientation, nationality, disability, or marital status. The Company does not tolerate any harassment or discrimination and every employee is highly valued and their rights and dignity are respected. The equal opportunities policy covers all permanent and temporary employees (including non-executive directors), all job applicants, agency staff, associates, consultants and contractors.

Please be aware the UK Government has taken steps to reduce net migration to the UK by limiting the number of overseas workers from outside the EEA coming to the UK for employment. Consequently, whilst we are able to consider applications from overseas workers from outside the EEA (who require a Tier 2 (General) Visa) we can only employ them if we can provide evidence that there are no other suitable candidates from inside the EEA.Therefore all Non-UK/EEA nationals’ applications will be kept on hold until we have pursued all candidates who currently have the right to work in the UK.