Requisition ID: QUA009096
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Quality Specialist will be responsible for supporting Critical Reagent programs in a fast-paced environment within the Vaccine franchises. The support is critical to testing within the Quality Control Laboratories. This position requires experience in general cell biology and either virology or biochemistry techniques. Under the guidance of an Associate Director, the Quality Specialist is responsible for independently managing the complete lifecycle of Critical Reagents such as; reference materials, positive controls, anti-sera and other critical materials. Release and stability testing of vaccine and biological products use these reagents. Reagent lifecycle includes; acquisition, certification and qualification testing, implementation and ongoing monitoring and replacement of the material as needed. Additionally, the individual will work independently and demonstrate leadership in the implementation, execution and management of reagents, as well as perform appropriate second person peer document reviews, support activities and project work associated with their position, and ensure work is conducted to the highest quality, compliant and conforms to current Good Manufacturing Practices and regulatory expectations. Provide bioanalytical support to Global MMD sites as needed and respond to regulatory questions, author of analytical license sections and support regulatory inspections.
Education Minimum Requirement:
- B.S. in Biochemistry, Virology or related biological science
Required Experience and Skills:
- Bachelor's with a minimum 2 years' of laboratory experience.
- Demonstrated leadership and teamwork skills and ability to work independently.
- Strong technical knowledge and high level of technical performance.
- Laboratory experience, knowledge of laboratory operations and bioanalytical instrumentation.
Preferred Experience and Skills:
- Previous technical and/or analytical problem solving experience in vaccine or biologics development, and/or quality site experience.
- Proficiency in classical biochemistry or virology assays.
- Experience in the following assays: ELISA, PCR, RNA Extractions, TCID50 assays, virus tittering, serum neutralization assays, plaque assays, cell culturing, Ouchterlony
- GMP experience.
- Statistical analysis experience with familiarity with JMP.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Visa sponsorship is not available for this position.
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Job: Quality Lab Related
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Yes - BSL Level 1 and 2
Company Trade Name: Merck
Nearest Major Market: Philadelphia