Analytical Method Development Specialist - CGT
Location:
King of Prussia , Pennsylvania
Posted:
November 21, 2017
Reference:
WD142840
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

Details:
Responsiblities
• 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.
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