Principal Scientist – Biologics and Vaccines Analytics Job - United States
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 125-year legacy. 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.
Biologics and Vaccines Analytics (BVA), Merck Manufacturing Division (MMD) is responsible for the commercialization of large molecule (vaccines, biologics) analytical techniques from Phase III through launch and transfer to supply as well as in-line analytical support to enable world-wide robust vaccine and biologics availability. This team is highly motivated, fast-paced and focused on the rapid advancement of Merck’s large molecule pipeline, plus growth of existing products. This position will influence all components of late-stage development, validation, transfer, and life cycle management of analytical methods supporting Merck’s pipeline and in-line vaccines. The selected candidate will be expected to lead development and execution of analytical strategies to support both pipeline and in-line vaccines.
Responsibilities (including, but not limited to the following):
- Develop and direct execution of analytical strategies associated with method development, validation, transfer, and life-cycle management to support recombinant vaccines
- Manage and lead a growing team of scientists tasked with providing analytical support to vaccine candidates in late-stage development as well as to in-line vaccines
- Interface across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMOs/CROs) in the area of vaccine analytics
- Coordinate with analytical and process development groups to prepare for and execute validation and technology transfers between Merck, external partners, and CMO/CROs
- Provide timely and effective trouble-shooting of analytical issues encountered within the Merck network as well as in external partner, government, and CMO/CRO laboratories
- Lead cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (e.g., Phase III clinical trials, launch preparation) for novel vaccines
- Lead preparation and execution of analytical method validations and transfers, including authoring, approving, and coordinating review of protocols and reports
- Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods
- Coordinate analytical issue resolution via subject matter experts within the global vaccines network
- Contribute as author and reviewer to regulatory submissions, including marketing applications
- Travel as required up to 20%
- Ph.D. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 5+ years of relevant industry experience; or
- M.S. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 10+ years of relevant industry experience
- At least 5 years working experience in the area of vaccine analytics in an industry setting
- At least 3 years working experience in a GMP setting
- Experience developing, validating, and transferring immunological/immunochemical, chromatography-based, and/or cell-based analytical methods
- Experience leading late-stage and/or in-line vaccine method development, validation, and transfer activities
- Demonstrated track record of success with trouble-shooting analytical issues—including those encountered in remote/international laboratories
- Experience leading cross-functional teams that support late-stage vaccine commercialization and marketed products
- Experience directing the laboratory activities of other analytical scientists
- Experience with vaccine drug substance and drug product specification setting and with release, stability, and extended characterization testing
- Experience with CMC document preparation, including authoring and review
- Experience in interactions with US and Ex-US regulatory authorities
- Strong organizational and project management skills
- Strong verbal and written communication skills
- Ability to work independently with minimal supervision
- Ability to effectively identify and communicate risks
- Experience with analytical change control processes
- Experience developing analytical comparability protocols and reports
- Experience in effectively managing analytical development and testing activity at external vendors
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: Biologics, Vaccines, Analytical Formulat
Job Title:Prin. Scientist, Bio & Vacc Formul
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Laboratory chemicals relevant to general biochemical analyses
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Chemistry, Analytics, Scientific, Medical, Biochemistry, Science, Management, Engineering, Healthcare