Manager - Analytical Development

09 May 2017
13 May 2017
Full Time
Basic qualifications: - Experience leading a team - potentially team lead rather than manager - Analytical Method Development Experience (Developing is key) - Good communication - BSc in biology, cell biology, virology, biochemistry or related scientific discipline Preferred qualifications: - Experience mentoring and developing staff - Hands-on experience in analytical development in support of recombinant viral vector production, gene therapy or cell therapy Details: Manager Analytical Development Details GSK has been working with a leading academic group in Italy to develop ex vivo gene therapies for Rare Diseases. We now have three late phase products. GSK has also secured a significant collaboration in the oncology area to develop transformational medicines. Additionally, GSK therapy areas and discovery groups are working on several early stage cell and gene therapy 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 Rare Diseases 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. Basic Qualifications BS in biology, cell biology, virology, biochemistry or related scientific discipline Experience in analytical method development/validation or QC for vaccines, biopharmaceutical or cell and gene therapy products Experience in analytical method transfers and control strategy development for biopharm/vaccine processes. Excellent leadership skills Demonstrable experience in leading lab-based team of scientists Strong organisational and excellent interpersonal communication skills Excellent technical write Experience mentoring and developing staffing skills Demonstrable ability to work in multi-disciplinary, multi-cultural teams Preferred Qualifications Advanced degree in biology, cell biology, virology, biochemistry or related scientific discipline Demonstrable experience in leading lab-based analytical development team Hands-on experience in analytical development in support of recombinant viral vector production, gene therapy or cell therapy Experience with developing assays for lentiviral and AAV based therapeutics Experience in mentoring and developing scientific staff Demonstrable capability in innovation with application of new/high throughput analytical techniques Experience generating regulatory documentation 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. If requiring an adjustment for a disability, once selected for interview you may contact Closing Date: 27th April 2017 LI-GSK Contact information: You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Salary: . Date posted: 03/04/2017