Analytical Method Development Specialist - CGT
King of Prussia , Pennsylvania
November 21, 2017
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
Demonstrated experience in analytical method transfers, method validation, and control strategy development for biopharm/vaccine processes.
Strong organisational and excellent interpersonal communication skills
Demonstrated excellence in technical writing skills
Demonstrable ability to work in multi-disciplinary, multi-cultural teams
Demonstrable ability to work independently, influence others and lead a project or team.

Preferred qualifications:
Experience in recombinant viral vector production, gene therapy or cell therapy
Experience with establishment and oversight of GMP manufacturing or QC in a late phase/commercial environment
Experience working with 3rd parties and developing/maintaining working relationships with these partners is critical
Experience participating in risk assessments
Experience participating in 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 reports supporting regulatory documentation

• Delivery of analytical method transfer to US manufacturing sites, CMOs or testing laboratories.
• Responsible for development of method qualification/validation project plans and strategies.
• Own and manage analytical methods lifecycle and ensure alignment with continued process verification plans
• Contribute to product specification development
• Responsible for conducting 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.
• Support capability build in other functional areas as needed
• Responsible for supporting trend analysis for continued process verification plans
• Responsible for successful interactions with contract manufacturing at third party manufacturers and testing laboratories. The role requires significant external engagement with 3rd parties (contractors, suppliers, testing laboratories, academic and industry groups).

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.

Closing date: Friday 24th November

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.

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.

Know someone who would be interested in this job? Share it with your network.