Sr. Scientist, Biologics & Vaccine Analytical Development
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 is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The individual hired for this position will be responsible for coordinating analytical support for one or more vaccines in clinical development. The individual will be responsible for:
• Working closely with the project leadership to identify testing requirements for various materials, forecasting test to the appropriate laboratories, and submitting samples
• Assisting with the identification and investigation of atypical test results
• Sourcing appropriate critical reagents and materials for method development projects
• Creating and maintaining GMP documentation.
• Serving as the primary point of contact for testing performed at one or more contract laboratories, forecasting future testing requirements
• Working with management to prioritize analytical activities
• Supporting method qualifications, transfers and validations including assisting with the study planning and documentation preparation
The individual may also be responsible for executing routine testing, supporting and/or leading method development activities, and evaluating new technologies related to the use of immunochemical methods used for release and stability testing for vaccines.
Requirements:
Education:
•A Bachelor's Degree in Chemistry, Biochemistry, Biology or a related discipline and a minimum of seven (7) years of industry experience with vaccine or biologics product development, OR a Master's Degree in Chemistry, Biochemistry, Biology or a related discipline, and a minimum of four (4) years of industry experience with vaccine or biologics product development.
Required
• A minimum of two (2) years of GMP experience.
• A minimum of two (2) years of experience running or developing immunoassays.
• Experience in 2 other analytical areas including separations, cell based assays, spectroscopy or biophysical methodologies.
• A minimum of two (2) years of experience supporting a cross-functional team.
• Strong communication skills and attention to detail is required.
Preferred:
• Project management experience.
• Experience working with a contract research or contract manufacturing organization.
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.
If you need an accommodation for the application process please email us at staffingaadar@merck.com.
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