Requisition ID: BIO005401
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.
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 stages of late stage development, validation, transfers and life-cycle management of methods supporting Merck's large molecule pipeline and inline products. Specific job responsibilities will include analytical development, scale-up and optimization, and commercial life-cycle management of analytical strategy for vaccines and biologics.
Participating in and/or leads cross-divisional teams focusing on late stage vaccine development as analytical lead, developing the analytical strategy, and as an analytical subject matter expert with line-of-sight for licensure and commercialization.
Responsible for development and validation of analytical methods for vaccine batch release and transfer to commercial quality laboratories.
Responsible for analytical method development and execution to support process development and characterization.
Actively interacting with internal and external counterparts. Will represent functional area on cross-functional and cross-divisional teams, as well as managing and interacting with internal and external testing labs.
Authoring required regulatory and technical documentation, ensuring that methods are developed and documented according to standard Merck practices and regulatory requirements.
Education Minimum Requirement:
B.S. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 10+ years of relevant industry experience;
M.S. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 6+ years of relevant industry experience;
Ph.D. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 3+ years of relevant industry experience.
Experience with late stage method development, validation, transfer, and trouble-shooting.
At least 3 years working experience in a cGMP laboratory environment in the area of large molecules (vaccines, biologics) with experience in immunochemical, and cell-based analytical methods.
Experience with deviation management and change control processes.
Strong organizational and project management skills.
Strong oral and written communication skills.
Ability to work independently with minimal supervision.
Ability to effectively identify and communicate risks.
Experience with drug substance and drug product release, stability and extended characterization testing for vaccines and biologics.
Experience developing analytical comparability protocols and reports.
Experience in effectively managing analytical development and testing activity at external vendors such as CMOs
CMC document preparation.
Experience with LIMS systems.
Experience with continuous improvement or lean six sigma methodology.
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: Biologics, Vaccines, Analytical Formulat
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; possibly, attenuated vaccine viruses
Company Trade Name: Merck
Nearest Major Market: Philadelphia
Merck & Co., Inc.