Manager, Analytical Development
- BS in biology, cell biology, virology, biochemistry or related scientific discipline
- 5 years' experience in analytical method development
- Advanced degree in biology, cell biology, virology, biochemistry or related scientific discipline
- Experience of vaccine, biopharmaceutical or cell and gene therapy product development
- Experience in CMC analytical development in support of recombinant viral vector production, stem cell and T-cell therapies
- Demonstrable experience in leading lab-based analytical development team
- Experience of leading cross-functional analytical project teams that set CMC analytical strategy for new medicinal products
- Experience with developing assays for lentiviral and AAV based therapeutics
- Knowledge of QbD approaches to analytical method development including risk assessment, DOE and statistical analysis
- Demonstrable experience in leading lab-based team of scientists
- Strong organisational and excellent interpersonal communication skills
- Excellent leadership skills
- Excellent technical writing skills
- Demonstrable ability to work in multi-disciplinary, multi-cultural teams
- Experience with establishment and oversight of development and testing at an external organization
- Experience working with 3rd parties and developing/maintaining working relationships with these partners
- Experience leading investigations into out of specification, out of trend or process deviations including root cause analysis, impact assessment and development of appropriate corrective and preventative actions
- Experience generating regulatory documentation
- Demonstrated experience in analytical method transfers and control strategy development
- Experience in mentoring and developing scientific staff
- Demonstrable capability in innovation with application of new/high throughput analytical techniques
GSK has been working with a leading academic group in Italy to develop ex vivo gene therapies for ultra-rare diseases. Having delivered on Strimvelis for the treatment of ADA-SCID, and given significant advances made on WAS and MLD, our focus is shifting to the development of treatments for more common blood disorders (e.g., beta thalassemia). In addition, GSK has also secured a significant collaboration in the oncology area to develop transformational medicines.
The progression of our own portfolio together with the promise of newer gene therapy technologies creates an imperative for GSK to build an industry leading gene therapy platform. This will enable delivery of the portfolio in blood disorders and oncology as well as ensuring that GSK is able to capture the potential of the emerging technologies.
The CMC capabilities for this platform are being built within the Platform Technologies and Sciences group. A key challenge in this endeavour is the development of suitable analytical methods that can support both process development and manufacturing of cell and gene therapy products. The successful candidate will join an analytical development group that is currently expanding in the UK and USA and will have the following responsibilities:
- Build and lead an analytical method development team comprising of 5-6 direct reports
- Develop innovative analytical methods that enable automation of testing and increase throughput for determination of product quality in the cell and gene therapy space
- Support external collaborations to enhance our analytical capabilities and enable the future vision of a robust and rapid testing strategy for cell and gene therapy products
- Development of analytical method and transfer to internal QC and Process Development laboratories, and CMOs or testing laboratories.
- Support establishing internal laboratories for analytical development for cell and gene therapy products
- Contribute to product specification development
- Participate in risk assessments to develop robust product control strategies for cell/gene therapy programs
- Responsible for management and successful closure of investigations
- Responsible for delivery of relevant sections of regulatory filings and responses to regulatory questions.
- Mentor and coach direct reports and set annual objective and development plans
European and international travel will be required at times, as dictated by the project needs.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies required for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.
You may apply for this position online by selecting the Apply now button.
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