Job Description

The Associate Principal Scientist position will support our Bacillus Calmette Guerin (BCG) franchise. This broad role includes driving method alignment and supporting consistent executional excellence across multiple testing laboratories, maintaining a robust assay monitoring effort, supporting method procedure life cycle management including automation and/or modernization as applicable, and many other cross functional interactions.

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 Durham, NC, and it’s a site-based position.

Responsibilities include but are not limited to:

Ensure execution of test methods is aligned and sustainable across multiple QC laboratories
Provide Subject Method Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations.
Responsible for assay monitoring ensuring 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 of BCG
Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between Company sites as well as and CMO/CROs
Provide input into cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure life cycle management.
Act as subject matter expert informing development and optimization of existing analytical methods to enable modernization of our testing strategies.
Accountability for analytical method transfers and in-line assay method validations, including review of protocols and reports.
Escalation of key assay challenges to management in a timely and concise manner.
Partnership with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testing.
Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.
Coordinate analytical issue resolution via subject matter experts within the global large molecule network.
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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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$139,600.00 - $219,700.00

This 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

Search Firm Representatives Please Read Carefully
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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

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), Optimistic Attitude, Process Analytical Technology (PAT), Protein Analysis, Teamwork

Preferred Skills:

Job Posting End Date:

07/7/2025

*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.