Merck & Co, Inc

Associate Principal Scientist, Analytical R&D

Merck & Co, Inc • $142K — $224K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree with 6 years or Master's Degree with 4 years, or PhD with 2 years of experience in analytical testing.
  • Demonstrated experience in analytics for commercial vaccines or microbiological products.
  • Strong understanding of large molecule GMP testing, stability, and release.
  • Experience leading cross-functional teams effectively.
  • Proficient in analytical comparability and method transfer protocols.

Responsibilities

  • Develop and implement commercialization analytical strategy with APLs across testing nodes.
  • Participate in critical investigations within the viral vaccines franchise.
  • Provide Subject Method Expertise to QC teams and assess change impacts.
  • Support equipment and technology improvements for assay modernization in collaboration with QC labs.
  • Develop strategies for sustainability in BCR inventory and antisera generation.
  • Guide APLC gap assessments to enhance method robustness.
  • Present method performance data at analytical working group meetings.

Benefits

  • Collaborative work environment with a focus on innovation.
  • Opportunity to lead significant projects affecting vaccine commercialization.
  • Exposure to cross-disciplinary collaboration within a global framework.
  • Direct involvement with external partners and regulatory bodies.
  • Potential for professional growth and development in a prominent pharmaceutical setting.
Full Job Description
Job Description

The Associate Principal Scientist position will support our Live Virus Vaccines (LVV) franchise. This broad role includes 1) working with Analytical Product Leaders (APLs) to develop and implement analytical strategies, with special focus on transition from clinical to commercial stages; 2) driving method alignment and supporting consistent executional excellence across multiple testing laboratories; 3) developing and maintaining a robust assay monitoring effort and supporting method procedure life cycle management, including automation and/or modernization as applicable.

This position is technical in nature and demonstrated expertise in vaccine analytics is required.

The role also requires effective collaboration with external contract providers as well as colleagues in our research laboratories, supply chain, site and global Quality, as well as CMC-Regulatory.

This role will be based in West Point, PA and it's a site-based position.

Responsibilities include but are not limited to:
  • Work with APLs to develop and implement the commercialization analytical strategy across testing nodes.
  • Participate in significant investigations across the viral vaccines franchise.
  • Provide Subject Method Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations.
  • In partnership with the AWG and network QC labs, support definition of the opportunities for improvement/investment in equipment and technology required to drive assay modernization and implement harmonized network solutions. This includes working with our Digital manufacturing Division and LMAS team for assay digitization with harmonized data capture.
  • In partnership with the BCR hub, develop short and mid-term strategy for sustainability in BCR inventory and antisera generation needed to support all testing laboratories in the network and connect BCR performance with assay performance as noted above.
  • Provide SME support to APLC gap assessments of key methods to drive improved and sustainable robustness.
  • Ensure method performance data are presented, discussed and actions developed at analytical working group meetings as appropriate.
  • Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) to ensure uninterrupted supply
  • Escalate key assay challenges to management in a timely and concise manner.
  • Support RTQs, PAI readiness and audit observations


Minimum Education Requirement and Experience:
  • Bachelor's Degree (BA/BS) with a concentration in sciences with six (6) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR
  • Master's Degree (MA/MS) with a concentration in sciences with four (4) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR
  • PhD with a concentration in sciences with two (2) years of experience working in the field of analytical testing, development, transfer, and/or validation.


Required Experience and Skills:
  • Demonstrated experience with analytics for commercial vaccine and/or microbiological products.
  • Effective communication and teamwork.
  • Experience with large molecule GMP testing, including drug substance and drug product stability and release testing.
  • Experience with analytical comparability.
  • Experience leading a cross-functional team.
  • Strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques.


Preferred Experience and Skills:
  • Continuous improvement or Project Management training.
  • Writing or review of technical documents, preferably including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA).
  • Experience with large molecule analytical transfers.
  • Experience with commercial product analytical method changes.
  • Experience with assay monitoring and trending.


VETJOBS

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Required Skills:
Adaptability, Analytical Method Development, Assay Development, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Optimism, Process Analytical Technology (PAT), Protein Analysis, Teamwork

Preferred Skills:

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Current Contingent Workers apply HERE

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
06/15/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

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Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

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Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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