BVA-Analytical Development and Outsourcing job in West Point
|Employer:|| Merck & Co.|
Requisition ID: BIO005253|
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) in our Manufacturing Division manages commercialization of vaccines and biologics throughout launch to supply. BVA provides analytical development, optimization, and support through a product's life cycle.
Activities within this dynamic environment include interfacing with a global network of product manufacturing and testing, collaborating with product development groups within our Manufacturing Division and our Research Laboratories, continuous improvement of analytical methodology, assay validation, analytical technical transfer, and Biologics License Application preparation.
In this role within BVA, opportunities include but are not limited to the following:
• Primary analytical point-of-contact for late-stage pipeline or in-line large molecule ( vaccine and biologics) program(s)
• Troubleshooting and optimization of analytical methods
• Validation and transfer of analytical methods
• Support for global filings, including author and review of license applications
• Continuous improvement using laboratory standardization, lean laboratory, and six sigma methodology.
• Vaccine/Biologics Assay Life Cycle activities across various vaccine/biologics franchises and analytical platforms.
• Collaborating with commercial manufacturing teams to support facility start-up activities and provide analytical support both within the Merck network and at contract manufacturing organizations (CMOs).
• Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
• Support various vaccine and biologics registrations, launches, and troubleshooting activities external to the US, including documentation preparation.
Education Minimum Requirement:
• Bachelors of Science (Biology, Chemistry, Biochemistry or related sciences) plus 6 years of experience OR an MS plus 4 Years of experience
Required Experience and Skills**:
• A minimum of 2 years of experience working in a GMP laboratory environment.
• Ability to work independently and within a cross-functional team.
• Ability to learn new techniques and multi-task.
• Detailed oriented and good project management skills.
• Experience with HPLC, ELISA, and/or Capillary Electrophoresis (CE).
• Good technical, communication (oral and written), interpersonal, and teamwork skills.
• Self-motivated with a positive attitude and proven performance record.
• Method development and validation experience.
Preferred Experience and Skills:
• Experience with continuous improvement or Project Management Professional certification.
• Global supply or launch experience.
• Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA).
• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ)
• Cross-functional team experience.
• Analytical or Project Lead experience.
• Method transfer experience with an external contract laboratory or global sites preferred
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to firstname.lastname@example.org .
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Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
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Job: Biologics, Vaccines, Analytical Formulat
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Lab chemicals
Company Trade Name: Merck