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.
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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, TeamworkPreferred Skills:
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The salary range for this role is
$142,400.00 - $224,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aJob 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.