Quality Control Laboratory Associate Specialist

JOB DESCRIPTION

We are seeking a Growth and Improvement minded Quality Control Laboratory Associate Specialist that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

EDUCATION

• Bachelor Science Degree

REQUIRED EXPERIENCE | SKILLS | KNOWLEDGE

• One year laboratory experience
• Experience authoring technical documents supporting regulatory filings (IND,BLA)
• Principled verbal and written communications
• Aseptic manipulations
• Exceptional pipetting techniques
• Technical writing skills
• Implementation and trouble-shooting of cell based and other microbiological/biological assays
• Previous GMP-laboratory experience

TRAVEL REQUIREMENTS:

No Travel Required

SUMMARY, FOCUS AND PURPOSE

Our Company is expanding its global vaccine production by adding an E2E manufacturing and laboratory in a new facility located in the Durham, NC campus. The new facility will be used to produce the bulk active ingredient, finished product and support laboratory testing for vaccines.
The Quality Control Laboratory Associate Specialist participates on a team of analysts in the method transfer, validation, and routine testing of the vaccine product. Initially the position will focus on microbiology, biological and biochemical assay validation and GMP laboratory readiness in preparation for commercial testing. At the completion of assay qualifications the Associate Specialist will execute routine testing of new and/or existing products, laboratory media preparation, continuing process improvements, troubleshooting, writing SOPs, and investigational testing support. The position will be responsible for testing in new and existing laboratories using principles of Company Production Systems, Lean Laboratories and GMP requirements. Scope of work may also include environmental monitoring of utilities and classified rooms to support new utility and facility qualifications.

EMPLOYEES WORKING IN ROLES THAT THE COMPANY DETERMINES REQUIRE ROUTINE COLLABORATION WITH EXTERNAL STAKEHOLDERS, SUCH AS CUSTOMER-FACING COMMERCIAL, OR RESEARCH-BASED ROLES, WILL BE EXPECTED TO COMPLY NOT ONLY WITH COMPANY POLICY BUT ALSO WITH POLICIES ESTABLISHED BY SUCH EXTERNAL STAKEHOLDERS (FOR EXAMPLE, A REQUIREMENT TO BE VACCINATED AGAINST COVID-19 IN ORDER TO ACCESS A FACILITY OR MEET WITH STAKEHOLDERS). PLEASE UNDERSTAND THAT, AS PERMITTED BY APPLICABLE LAW, IF YOU HAVE NOT BEEN VACCINATED AGAINST COVID-19 AND AN ESSENTIAL FUNCTION OF YOUR JOB IS TO CALL ON EXTERNAL STAKEHOLDERS WHO REQUIRE VACCINATION TO ENTER THEIR PREMISES OR ENGAGE IN FACE-TO-FACE MEETINGS, THEN YOUR EMPLOYMENT MAY POSE AN UNDUE BURDEN TO BUSINESS OPERATIONS, IN WHICH CASE YOU MAY NOT BE OFFERED EMPLOYMENT, OR YOUR EMPLOYMENT COULD BE TERMINATED. PLEASE ALSO NOTE THAT, WHERE PERMITTED BY APPLICABLE LAW, THE COMPANY RESERVES THE RIGHT TO REQUIRE COVID-19 VACCINATIONS FOR POSITIONS, SUCH AS IN GLOBAL EMPLOYEE HEALTH, WHERE THE COMPANY DETERMINES IN ITS DISCRETION THAT THE NATURE OF THE ROLE PRESENTS AN INCREASED RISK OF DISEASE TRANSMISSION.

Current Employees apply HERE
Current Contingent Workers apply HERE