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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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.Responsibilities:
- Perform hands-on laboratory support, troubleshooting and optimization of analytical methods.
- Direct interaction (Oversight and collaboration) with external contract research organizations for outsourced analytical methods.
- Function as a key team member to validate and transfer analytical methods.
- Support analytical compliance and Quality for investigations and corrective actions.
- Collaborate with contract staffing on initiation, execution, and delivery of testing.
- Support Vaccine Assay Life Cycle activities across various vaccine franchises and analytical platforms.
- Support various vaccine registrations, launches, and troubleshooting activities external to the US, including documentation preparation.
- Coordinate global reagent and sample submissions.
- Support strategic initiatives within departmental and cross-functional teams representing GVBC-BVA.
- Function as a key member to support and lead the design and execution of method transfers to Merck global network of vaccine nodes.
- Travel, as required (up to 10%).
- Bachelor's degree in biology, chemistry, biochemistry or related sciences.
- Experience working in a cGMP laboratory environment in the area of vaccines.
- Capability to manage individual components of a project.
- Good technical, communication (oral and written), interpersonal, and teamwork skills.
- Self-motivated with a positive attitude and proven performance record.
- Experience with at least one of the following techniques:
- Viral Infectivity assays (plaque/TCID50/others)
- Plaque assay
- Cell Culture
- PCR/RT-PCR (traditional and real-time)
- Sequencing (traditional and MPS)
- Separation (e.g. HPLC/UPLC)
- Experience working with contract research organizations and/or procurement
- Ability to work independently and work within a cross-functional team
- Experience with LIMS systems.
- Assay validation experience.
- Experience with continuous improvement or lean six sigma methodology.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
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Visa sponsorship is not available for this position.
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