Merck & Co, Inc

Analytical Project Lead (Associate Principal Scientist)

Merck & Co, Inc • $142K — $224K *
Elkton, VA 22827In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's or Master's in sciences with relevant experience in analytical testing, development, and validation
  • Strong background in large molecule GMP testing, including stability and release
  • Proven experience leading cross-functional teams
  • Excellent communication and collaboration skills
  • Technical expertise in large molecule analytical operations and techniques

Responsibilities

  • Collaborate with internal and external stakeholders on large molecule analytics
  • Coordinate troubleshooting and validation with internal and external partners
  • Guide teams to align analytical strategies with Quality Systems
  • Steer development and optimization of analytical methods
  • Manage analytical method transfers and validate in-line assay methods
  • Monitor assays rigorously to ensure a robust testing network
  • Take responsibility for global analytical method ownership

Benefits

  • Comprehensive medical, dental, and vision insurance
  • 401(k) retirement benefits
  • Paid holidays, vacation, and sick days
  • Compassionate leave
  • Annual bonus and long-term incentives, if applicable
Full Job Description
Job Description

The Analytical Project Lead role includes driving analytical strategy, managing analytical procedure lifecycle activities, maintaining a robust assay monitoring effort, participating in product strategy discussions, global method ownership, and many other cross functional activities. This position will require 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.

Responsibilities
  • Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in large molecule analytics
  • Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between our company, external partners and CMO/CROs
  • Guide cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure lifecycle management
  • Steer teams of subject matter experts to develop and optimize existing biochemical, immuno-chemical and chromatography-based 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
  • Routine assay monitoring and trending to ensure a robust analytical testing network
  • Ownership of product-specific global analytical methods including routine evaluation of methods for analytical lifecycle changes
  • Escalation of key project 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


Qualifications

Required
  • Bachelor's Degree with a concentration in sciences with eight (8) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Master's Degree with six (6) years; OR PhD with three (3) years
  • 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
  • Continuous improvement or Project Management training
  • Experience with global product supply
  • Writing or reviewing of regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA)
  • Experience with large molecule analytical transfers
  • Experience with change controls
  • Experience with assay monitoring and trending


Required Skills:
Adaptability, Adaptability, Analytical Method Development, Analytical Testing, Assay, Assay Development, Biochemical Assays, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Collaborative Communications, Cross-Functional Teamwork, Effective Written Communication, External Collaboration, Global Product Management, Global Supply Chain, GMP Compliance, GMP Operations, GMP Training, High Resolution Mass Spectrometry (HRMS), In Vitro Assays, Liquid Chromatography-Mass Spectrometry (LC-MS), Management Trainings, Mass Spectrometry Analysis, Optimism {+ 7 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

The salary range for this role is
$142,400.00 - $224,100.00

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:
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:
07/11/2026
*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.

Explore Career Paths

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.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Engage with us through our careers blog and by participating in networking events and employment fairs. Subscribe to receive personalized job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding opportunities that await at Merck & Co, Inc. Join us in our mission to improve health and wellness around the world.
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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