Associate Director - Analytical Science Subject Matter Expert Job
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.
The Analytical Science Subject Matter Expert is responsible to provide oversight, tracking and management of analytical issues across a portfolio of vaccine products. The position resides within a Technical Operations Center of Excellence and supports vaccine manufacturing operations within the Merck Manufacturing Division. The Analytical Science Subject Matter Expert works closely with traditional analytical methods development groups, laboratories and Quality Control (QC) groups, but does not have direct responsibility for development or QC work. The incumbent serves as the interface between these analytical organizations and the Technical Operations organization.
The incumbent will serve as the advisor to the Technical Operations organization on analytical matters and will ensure that analytical work being done by the analytical organizations is aligned and coordinated into a holistic cross-functional plan. As such, the incumbent must be knowledgeable on a wide range of analytical methods and be knowledgeable about methods development, tech transfer and qualification.
The incumbent will be responsible to:
Stay abreast of scientific and regulatory trends in area of vaccines analytical methods and QC testing
Provide technical/scientific guidance and oversight to project teams that are doing analytical changes, improvements or technology transfers to ensure scientific rigor and sound execution
Provide technical/scientific guidance to analytical investigations
Oversee a large portfolio of analytical projects and investigations to ensure that the work plans are sounds, execute to schedule, and to communicate updates (including technical assessment) to the Technical Operations project teams
Establish company "best practices" and standards where appropriate as relate to their area of expertise
Develop recommendations and options for analytical improvements
- Bachelor of Science or equivalent in a technical or scientific discipline such as Biology, Chemistry or Chemical Engineering.
- MS or PhD is preferred.
- Experience with analytical testing (QC and/or characterization) of commercial biological products. For candidates holding a BS or equivalent, a minimum of 6 years in their subject area is required. For candidates holding a MS or PhD, a minimum of 3 years is required.
- Experienced in formal experimental design.
- Experience with analytical methods development, technology transfer and/or qualification.
- The successful candidate must demonstrate a solid understanding and respect for scientific method and scientific decision-making.
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: Quality Lab Related
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck