Director, Vaccines and Biologics Analytics Job - United States
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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), Global Vaccines and Biologics Commercialization (GVBC), Merck Manufacturing Division (MMD) is responsible for the commercialization of vaccine analytical techniques from Phase III through launch and transfer to supply as well as in-line analytical support to enable world-wide robust vaccine availability. This team is highly motivated, fast-paced and focused on the rapid advancement of Merck’s vaccines 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 vaccines 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.
- Lead a scientific team in the design and execution of method transfers to Merck global network of vaccines nodes. Participate locally as required
- Interface across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of vaccine analytics.
- Coordinate with multiple analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and transfers between Merck, external partners and CMO/CROs.
- Lead cross functional teams and ensure alignment of analytical strategies with Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel vaccines and processes.
- Provide technical and strategic oversight to the development and optimization of molecular/cellular biology-based, cell-based, microbiological, immunochemistry, separation, all relevant analytical methods and preparation and execution of method transfers and validations.
- Provide on-going support to internal and external partners to resolve analytical issues and trouble-shooting.
- Assist with the technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.
- Coordinate analytical issue resolution as needed 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 25%
- Ph.D. in molecular/cellular biology, bioengineering or equivalent bio-related science with 5+ years of relevant industry experience;
- M.S. in molecular/cellular biology, bioengineering or equivalent bio-related science with 7+ years of relevant industry experience;
- B.S. in molecular/cellular biology, bioengineering or equivalent bio-related science with 10+ years of relevant industry experience
- Experience in molecular/cellular biology and biochemistry techniques: Bioassay, Viral Infectivity assays (plaque/TCID50/others), cell culture, ELISA, PCR/RT-PCR (traditional and real-time), Sequencing (traditional and MPS), Separation, CE, MS
- At least 4 years of significant GMP experience.
- Project leadership and people management experience.
- Track record of achievement in the vaccine industry particularly in the areas of vaccines analytics.
- Highly developed communication, team building and interpersonal skills.
- Ability to function well in ambiguity.
- Knowledge of compliance and regulatory requirements in vaccines including assay validation.
- Experience with Code of Federal Regulations, Quality Standards, and cGMP for CMC document preparation
- 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.
If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job Title:Dir, Chemistry
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: Yes
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Biochemistry, Microbiology, Molecular Biology, Analytics, Data Analyst, Science, Management, Data