Manager, Analytical Development - Cell & Gene Therapy

Your Responsibilities:
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.

GSK's Cell & Gene Therapy Platform CMC team is being expanded to support an increasing portfolio of cell and gene therapies. The team is responsible for delivering the Chemistry, Manufacturing and Controls (CMC) aspects of the projects from early phase to launch and the development of innovative technologies to enable step-change improvements to cell & gene therapy manufacture.

GSK has a significant collaboration in the T cell immunotherapy field with Adaptimmune and other licensing/partnership opportunities are being pursued. The progression of our own portfolio together with the maturation of emerging gene therapy technologies creates an imperative for GSK to now increase our investment in this space and establish an end to end leading platform. This will facilitate delivery of the portfolio in Oncology as well as ensuring that GSK is able to capture the potential of the emerging technologies in other therapeutic areas.

A key CMC 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 that are focussed on cell analytics
• 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.

Why You?

Basic qualifications:
• BS in biology, cell biology, virology, biochemistry or related scientific discipline
• Experience in analytical method development
• Demonstrable experience in leading lab-based team of scientists

Preferred qualifications:
• Advanced degree in biology, cell biology, virology 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, especially flow cytometry-based methods (e.g. for immunophenotyping), cell counting and viability assays, and cell potency assays (e.g. killing assays)
• Knowledge of QbD approaches to analytical method development including risk assessment, DOE and statistical analysis
• 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 cell and vector process comparability studies
• Experience in mentoring and developing scientific staff
• Excellent leadership skills
• Demonstrable capability in innovation with application of new/high throughput analytical techniques
• Strong organisational and excellent interpersonal communication skills
• Excellent technical writing skills
• Demonstrable ability to work in multi-disciplinary, multi-cultural teams

Why GSK?:
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.

We want to help people do more, feel better, live longer

We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time.

As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

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