Job Description

The Specialist in the Global Quality Biological Critical Reagents (LM-BCR) group will be responsible for supporting the BCR programs. This position will potently perform hands-on laboratory work in biochemistry, virology, and/or cell biology techniques for biological critical reagents, such as antibodies and antiserum, using cell based assay, ELISA, SDS-PAGE; coordinate testing lab or quality control lab to qualify testing for the biological critical reagents, strong knowledge of immunology, biology, vaccine, and assay developentment, be able to have the ability to trouble shooting for testing assay. Under limited guidance, the incumbent will independently support the entire lifecycle of BCRs, from generation and testing to inventory and shipping. All work will be conducted to the highest quality and conform to GMP and regulatory expectations.

The Specialist in the LM-BCR group will be responsible for supporting Critical Reagent programs in a fast-paced environment within the vaccines and Biologic franchise. The performance of the critical reagents used in release and stability testing within the Quality Control Laboratories is important for release of Vaccine and Biologic products. This position requires experience in general cell biology, molecular biology, virology and/or biochemistry techniques. Under the guidance of a Manager, the Specialist is responsible for independently managing the complete lifecycle of critical reagents, including antibodies and antiserum critical materials. The BCR lifecycle includes acquisition, certification and qualification testing, implementation, sample and inventory management, and ongoing monitoring and replacement of the material as required per established procedures. Additionally, the individual will demonstrate leadership in the implementation, execution and management of BCRs, and ensure work is conducted to the highest quality, and conforms to current Good Manufacturing Practices and regulatory expectations. The Specialist will provide bioanalytical support to our Company Global Manufacturing Division sites as needed and respond to regulatory questions, author of analytical license sections, and support regulatory inspections. In addition, the Specialist is able to pursue alignment among peers, stakeholders, and customers; actively seek opportunities for improving department processes and increasing efficiencies; acts as a subject matter expert and resource to others; delivers effective and influential presentations which are tailored to the target audience; and quickly identifies potential sources of problems and develops solutions to be implemented. The individual will also facilitate trainings and frequently share information to transfer technical and scientific knowledge to other members of BCR.

Skills:

Education Minimum Requirement:

• B.S., M.S. in Biology, Molecular Biology, Biochemistry, or related biological science

Required Experience and Skills:

• Bachelor’s degree with 3 to 5 years of hands-on laboratory experience, or Master’s degree with 1 to 2 years of laboratory experience.
• Demonstrated leadership, teamwork, strong communication, and time management skills with the ability to work independently.
• Experience managing teams and coordinating multi-component projects.
• Strong technical expertise and consistently high technical performance in laboratory settings.
• Proficient knowledge of laboratory operations and bioanalytical instrumentation.
• Experience working under GMP guidelines.
• Ability to plan, prioritize, and independently manage complex operations and projects.
• Proven ability to meet deadlines and deliver high-quality products.
• Effective collaborator within cross-functional teams.
• Strong technical and analytical data interpretation skills.

Preferred Experience and Skills:

• Previous technical and/or analytical troubleshooting experience in biologics development, and/or quality laboratory experience
• Proficiency in virology, biochemistry, and/or cell biology techniques
• Statistical analysis experience and/or familiarity with JMP software
• Judgment, organization and project management abilities

Current Employees apply HERE

Current Contingent Workers apply HERE

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

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

$85,600.00 - $134,800.00

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Accountability, Accountability, Adaptability, Analytical Instrumentation, Analytical Method Development, Assay, Audience Targeting, Biochemical Analysis, Biochemistry, Clinical Immunology, Dissolution Testing, Driving Continuous Improvement, Enzyme Linked Immunosorbent Assay (ELISA), GMP Compliance, Immunochemistry, Inventory Management, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Management Process, Microbiological Analysis, Microbiological Test, Molecular Biology, Project Management, Quality Control Management {+ 4 more}

Preferred Skills:

Job Posting End Date:

10/7/2025

*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.