Senior Toxicology Scientist Cambridge

Senior Manager Manufacturing Technical Support Kent Science Park

Website GW Pharmaceuticals

Unlock the potential of cannabinoid science to transform the lives of the patients and their families

Senior Manager Manufacturing Technical Support (M/W/D) – Full Time

About the role:

To lead the Manufacturing Technical Support Group, reporting into the Senior Manager for the Manufacturing Technical Team.

This role will be responsible for managing the team, providing day-to-day technical support to Botanical Drug Product (BDP) and Botanical Drug Substance (BDS) manufacturing areas. This role will also manage Cleaning Validation activities on site.

The incumbent will develop and maintain critical business relationships with various cross-functional departments and cross-business customers (QA, Commercial, R&D, Engineering, and Supply Chain, for example).

Key Responsibilities/Accountabilities:

  • Manage/lead the team to provide Technical Support to Production and the wider Manufacturing Operations groups. Provide resolution and support to manufacturing for process issues and investigations, process optimization, and process improvements.
  • Manage/ lead cleaning validation team and associated activities on site. Plan, coordinate and execute production facility/ equipment cleaning validation/ verification activities.
  • To support the delivery of company and site objectives to the required Quality, Regulatory, and EHS standards.
  • Ensure systems and processes conform to all relevant EHS, cGMP, and Validation requirements.
  • Lead and support commissioning and qualification/ process validation activities.
  • Support activities associated with technical transfers.
  • To develop effective working relationships with other key support functions to meet critical objectives.
  • To ensure that the Manufacturing Technical Support Team are “audit ready” for areas where they are Subject Matter Experts (SME’s)
  • Where required deputize for and sign off relevant documentation in place of Manufacturing Technical Senior Manager.

Detailed Responsibilities/Accountabilities:

  • Manage the technical support team comprising of personnel various skillsets/ competencies to meet key and critical Production Department, Manufacturing Operations, and wider business objectives.
  • Develop team and individuals within the team to expand expertise, experience, and core competencies to ensure the team continues to deliver in a fast-changing and challenging environment.
  • Ensure team delivers against agreed project deliverables, including but not limited to, quality, time, and budget, and that timely communication to key stakeholders and customers are carried out. Lead and participate in project teams as necessary to achieve the company goals and objectives.
  • Ensure team lead and support investigations/ troubleshooting into quality, safety, and downtime issues in manufacturing areas, using RCA tools as appropriate.
  • Review, monitor, and communicate compliance metrics within the team to ensure no overdue change controls, CAPAs, and deviations.
  • Ensure all team activities meet all relevant EHS and Quality standards.
  • Promote an H&S aware culture and the reporting of all H&S near misses and lead by example.
  • Support process safety studies and initiatives.
  • Look to continuously improve both efficiency and effectiveness of manufacturing processes and associated systems to help meet the future needs of the business.
  • Lead/ Support the planning, design, commissioning, and qualification activities associated with new and improved production facilities/ processes, including production equipment and process validation activities.
  • Support scale-up and technology transfer of production processes. Interface with R&D and Technical Transfer Lead to ensure effective and efficient transfer of new processes/products into internal Production facilities and external Contract Manufacturing Organisations (CMOs).

Cleaning Validation: Role and team are responsible for:

  • Plan, coordinate, and execute appropriate equipment CV related tasks to ensure that process equipment is adequately validated for commercial use.
  • Generate, review, and approve CV related documentation such as cleaning verification/ validation protocols, deviations, and summary reports.
  • Develop and Perform Cleaning validation reviews.
  • Ensure that new products, processes, and equipment are appropriately assessed, and the necessary activities are carried out in support of cleaning validation or verification needs.
  • Lead continuous improvement initiatives associated with cleaning.
  • Collaborate with Production/ Manufacturing Operations colleagues in developing new cleaning methods (as required) and assist in writing new cleaning or equipment cleaning procedures accordingly.
  • Develop the appropriate documentation to capture equipment product surface areas; material of construction; swab points/ sites in collaboration with relevant support functions.

Key Attributes/Skills/Education – Essential:

Relationships:

  • Actively seeks to form long term relationships with key groups; Manufacturing Operations, QA, QC, Regulatory Affairs, Engineering, R&D, Commercial Contract Manufacturing group, and leaders across the site.

Knowledge, Skills, and Experience Required:

Essential:

  • Professionally qualified/ equivalent experience in a relevant technical discipline. Chemistry or chemical/ process engineering would be preferred.
  • Demonstrated track record of leading a team/ managing people.
  • At least five years’ experience within the pharmaceutical industry.
  • Demonstrable knowledge of cGMP.
  • Demonstrable track record of technical project delivery and project management.
  • Excellent communication skills, including oral, written, presentation, and regular report writing.
  • High level of numeracy
  • Proficiency in Microsoft Word and Excel.
  • Excellent oral, written, and presentation skills.

GW’s VISION:

Unlock the potential of cannabinoid science to transform the lives of the patients and their families

GW’s MISSION:

Lead the world in developing and commercializing regulatory approved cannabinoid medicines, putting patients first

Several fundamental values guide our efforts. At all times, we strive to be:

Patient-Driven – We never forget who we’re striving for

Passionate – We are here to change lives

Innovative – We challenge ourselves to find new and better approaches

Collaborative – We accomplish more through working together and valuing one another

Accountable – We take responsibility and deliver on our commitments

Integrity – We are fair, honest, and ethical.

Excellence – We pursue the highest standards for ourselves and our industry

Join Us!

Apply directly on the company website HERE.

Senior Manager Manufacturing Technical Support Kent Science Park

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