Manufacturing Manager (Cell and Gene Therapy - CGT), Open to flexible working
GSK are currently looking to recruit a highly capable Manufacturing Manager to facilitate the commission and set-up of a Cell and Gene Therapy (CGT) manufacturing facility and take this to routine manufacture capability.
Joining a dynamic team to execute the commissioning of the manufacturing facility, you will be instrumental in the development of processes and procedures for manufacturing operations and support activities. This will include technology transfer and validation release, through to technology-transfer of early to late phase processes in manufacture of Cell and Gene Therapy (CGT) clinical Drug Product.
The role reports directly into the Director of Manufacturing for Catapult. Currently the position has 5 reports (due to expand in 2021).
This is a fantastic opportunity to utilise your Leadership and Management skills, as well as develop your technical expertise, within a world leading pharmaceutical company. As a member of the site Management Team, we positively engage with team members and wider matrix leadership in the project team. This includes leadership and oversight for robust performance of the manufacturing processes (Right First-Time) and efficient release timelines, all whilst promoting and adhering to safety, quality, and compliance standards and requirements.
You will be responsible for developing and maintaining a team of manufacturing scientists, who will deliver the GMP facility in 2021 (with production starting 2022). Responsibilities will extend to developing GMP manufacturing scale-out and technology transfer methodologies and all related Validation processes. This includes problem solving involving equipment, scale, raw materials, process optimization/changes and implementing robust process controls. You will also establish production standards and staffing requirements to meet delivery schedules planned for 2022.
Please Note: We are particularly interested in applicants who have practical hands on experience in Cell and Gene Therapy (CGT), biopharmaceuticals, vaccines and/or sterile product manufacturing processes.
We are seeking a self-motivated line-manager, with strong experience of working in complex highly regulated environments. A capacity to develop processes and execute is required and ideally experience in processes that have been transferred in for clinical and then commercial manufacturing capacity. Resilience and a calm-approach, strong communication skills and ability to influence people to achieve objectives and drive performance are key. A strong continuous improvement approach and an understanding of Good Manufacturing Practice (GMP) procedures and safety are also required.
About Stevenage R&D Site:
GSK's Medicines Research Centre at Stevenage is a major R&D facility for the company, acting as a center of excellence for research into Respiratory, Inflammation and Respiratory conditions. It has been designated a satellite site for the company's research into Neurology / Cardio-Vascular diseases. The site employs over 3,000 people and is at the heart of GSK's global efforts to develop new medicines.
APPLICATION CLOSING DATE - Monday 15th of March 2021 (COB).
When applying, please include your CV in your online application to describe how you meet the competencies for this role. The information that you provide in your CV will be used to assess your application.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites. For more information on GSK please refer to our website: www.gsk.com
- Management experience within a highly regulated (Pharmaceutical) manufacturing industry is essential.
- Expertise in Cell and Gene Therapy (CGT), biopharmaceuticals, vaccines or sterile products manufacture.
- Excellent knowledge of Good Manufacturing Practice (GMP).
- Strong experience of technical core skills (e.g. engineering / supply chain / manufacturing / etc.) in manufacturing industries.
- Degree in relevant Scientific or Engineering discipline.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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