Methods Specialist

CamWebDir; Rahway (NJ); Hybrid; GBP 60,000 - 94,000; Full time

Job summary

Merck & Co., Inc. is seeking a Methods Specialist to support biomaterials management, documentation, and regulatory activities for USDA-regulated biologics.

The role ensures accurate inventory, qualification, and method remediation while coordinating with Manufacturing, QC, QA, Regulatory Affairs, R&D, and external partners. The candidate will develop expertise in at least one biological method platform, produce technical reports, and assist with regulatory submissions.

Qualifications

• Bachelor’s degree in a biological science such as Biology, Microbiology, Genetics, Virology, or closely related discipline.
• Minimum of 5 years of experience in USDA-regulated animal health biologics, veterinary biologics.
• Developing subject matter expertise in at least one biological method platform (e.g., immunoassays, cell-based methods, or related test systems).

Responsibilities

• Maintain biomaterials documentation including production history, characterization, inventory status, qualification status, and method dependencies.
• Monitor biomaterials inventory, usage trends, expiry risks, and reorder triggers.
• Support biomaterials replacement planning, sourcing evaluations, and equivalence qualification activities.
• Assist with method remediation when biomaterials impact biological method performance.
• Support transfer of biomaterials and remediated methods to QC laboratories.
• Draft or contribute to technical reports, qualification summaries, scientific justifications, and regulatory support documents for USDA or CVB review.
• Collaborate with Manufacturing, QC, QA, Regulatory Affairs, R&D, Supply Chain, and external suppliers.

Skills

Adaptability

Analytical Method Transfer

Biomaterials

Biology

Bioproducts

Immunoassays

Cell Separation

cGMP Compliance

Column Chromatography

Data Analysis

Computer Literacy

Education

Bachelor’s degree in Biological science

Tools

Column Chromatography

Computer Literacy

Job description

Job Description

Job Description In Primary Posting Language (Include Requirements For Education, Experience And Skills)

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.

Methods Specialist

The Methods Specialist supports biomaterials management and method remediation activities for USDA-regulated animal health biologics. This role helps maintain biomaterials documentation, monitor inventory, support replacement and equivalence qualification activities, assist with QC transfer, and prepare technical documentation for regulatory review.

Key Responsibilities

• Maintain biomaterials documentation, including production history, characterization, inventory status, qualification status, and method dependencies.
• Monitor biomaterials inventory, usage trends, expiry risks, and reorder triggers.
• Support biomaterials replacement planning, sourcing evaluations, and equivalence qualification activities.
• Assist with method remediation when biomaterials impact biological method performance.
• Support transfer of biomaterials and remediated methods to QC laboratories.
• Draft or contribute to technical reports, qualification summaries, scientific justifications, and regulatory support documents for USDA or CVB review.
• Collaborate with Manufacturing, QC, QA, Regulatory Affairs, R&D, Supply Chain, and external suppliers.

Minimum Qualifications

• Bachelor’s degree in a biological science, such as Biology, Microbiology, Genetics, Virology, or a closely related discipline.
• Minimum of 5 years of experience in USDA-regulated animal health biologics, veterinary biologics.
• Developing subject matter expertise in at least one biological method platform, such as immunoassays, cell-based methods, or other relevant biological test systems.
• Strong scientific documentation and technical writing skills.

Preferred Qualifications

• Experience qualifying biomaterials or preparing biomaterials-related technical documentation for regulatory review.
• Experience working with CVB or supporting USDA-regulated veterinary biologics submissions.
• Experience with regulated quality systems, method validation, method transfer, or method remediation.
• Experience collaborating across multiple departments or external organizations.

Required Skills

Adaptability, Adaptability, Analytical Method Transfer, Biocompatibility, Biologics, Biology, Biomaterials, Bioproduction, Bioproducts, Bulk Load, Cell Separation, cGMP Compliance, Column Chromatography, Computer Literacy, Contract Manufacturing, Data Analysis, Environmental Health and Safety (EHS) Management, Equipment Set Up, External Manufacturing, Immunoassays, Lean Manufacturing Tools, Method Development, Method Validation, Microbiology, Process Monitoring {+ 10 more}

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $79,200.00 - $124,700.00. 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.

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

Job Posting End Date: 10/9/2026*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.