Senior Stability Specialist
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.
This position primarily supports the stability program for an immuno-oncology biological product. A successful applicant will be responsible for developing stability strategies and protocols in support of pre-approval and routine commercial stability studies. This includes coordinating with labs (including external parties) to ensure implementation of stability studies, evaluating stability data (including statistical evaluation and preparation of data in regulatory filings), and investigating atypical and out of specification stability results as needed. The applicant will maintain clear and effective verbal and written communication with internal and external customers, participate in cross-functional teams related to stability studies, and may represent stability on site and divisional initiatives.
- B.S., M.S., or PhD in chemistry, biological science, pharmacy or related science or engineering field.
- Minimum 5 years of experience in a laboratory, technical services, and/or quality analyst position.
- Demonstrated statistical experience in analyzing data and trends.
- Experience authoring regulatory documents or written agency communication.
- Experience with change request support.
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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Job: Quality Operations
Employee Status: Regular
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Company Trade Name: Merck