Assoc. Dir, Quality

Job Description

The Site Analytical Science team within Global Quality- Large Molecule Analytical Sciences (GQ-LMAS) team provides support of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support.  The position will work closely with partners with Large Molecule Analytical Science (GQLMAS), Sterile Quality Assurance Center of Excellence, Technical Operations, Operations and our manufacturing division Quality to provide site microbiology support. The successful candidate will have the opportunity to apply his or her enthusiasm and microbiological skills in the operation and improvement of a manufacturing facility. This role requires the ability to manage multiple complex projects, activities, and/or investigations. The role also requires active participation in cross-functional site teams.

Primary activities include, but are not limited to:

• Provides microbiology support to the production departments that manufacture sterile vaccines.

• Provide education and coaching on aseptic techniques, Good Manufacturing Practice requirements, and regulations including European Annex 1.

• Provide microbiology support to operational investigations and problem-solving, including leading and authoring investigations and analyses to determine root cause and impact, recommending corrective actions, and seeing them through to successful, sustainable implementation as well as reviewing investigations and analyses for thoroughness and accuracy.

• Providing microbiological leadership and support for a vaccine manufacturing facility, including data analysis, troubleshooting, problem solving, coaching/teaching, preparing, reviewing and approving relevant documentation for technical and regulatory compliance

• Participation in internal and external audits

• Troubleshooting of suspected Microbiological Contamination incidents

Education

• B.S. or B.A. degree in Biology, Microbiology or related science with ten (10) years of relevant experience that includes quality assurance/control, microbiology research or manufacturing operations

• Master’s Degree (MA/MS) in Biology, Microbiology or related science with eight (8) years of relevant experience that includes quality assurance/control, microbiology research or manufacturing operations

• PhD with a concentration in Biology, Microbiology or related science with five (5) years of relevant experience that includes quality assurance/control, microbiology research or manufacturing operations

Required Experience and Skills

• Extensive knowledge of clinical and environmental microbiological principles

• Strong problem-solving skills and a hands-on approach to problem solving

• Sterile, aseptic, or microbiological experience in a manufacturing environment

• Working knowledge of regulatory expectations of aseptic processing

• Project management skills and experience

• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.

Preferred experience and skills

• National board certification or licensure in Microbiology or related discipline (E.x. ABMM (ASM), MLS/SM (ASCP), etc.)

• Working in a cGMP environment

• Participation in regulatory agency inspections

• Demonstrated leadership skills and the ability to find innovative solutions to problems and requests.

• Experience with laboratory data management systems (i.e., LIMS)

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protect