Job Description

Job Description:

The Global Biologics Lab in North Wales, Pennsylvania (NW4) is part of the Global Quality Large Molecule Analytical Sciences organization within our Company's Manufacturing Division and is responsible for providing global analytical support for our Company's in-line products to enable world-wide robust product availability and managing the materials and samples which are used as critical reference parameters in release and stability testing of biological products, named Biological Critical Reagents (BCRs).

Position Description:

Supporting the qualification, ongoing monitoring, and stability of BCRs within the global Biologics franchises.

This position will work in a current Good Manufacturing Principles (cGMP) environment under the direction of the lab manager and will be expected to execute bioassays for large molecule critical reagents and contribute to maintenance of cGMP compliant labs. The candidate will work with colleagues to deliver high quality results for these assays by supporting assay execution, transfer, technical troubleshooting, and reagent qualification, ongoing monitoring and stability supporting our company's Biologic Critical Reagents.

Specific Job Responsibilities Include:

• Support the qualification, ongoing monitoring, and stability testing of BCRs and support assay execution, transfer, technical troubleshooting and life-cycle management of the company’s in-line biologics through lab testing and collaboration within the network.

• Execute analytical laboratory methods and analysis such as ELISA, HPLC, CE.

• Documentation of laboratory work according to Good Manufacturing Principles (GMP) and manage activities like deviation management.

• Support deviations (incidents and investigations) through owning investigations, data gathering, hypothesis testing, root cause analysis or other technical troubleshooting, and implement associated CAPAs.

• Provide support in responding to regulatory questions.

• Support the transfer of BCRs of new biologic products from our Manufacturing Division Commercialization or Research Laboratories to the Global NW4 Biologics Lab.

• Engage with analytical teams for the initial BCR identification and qualification to leverage knowledge between the BCR function and analytical teams.

• Ability to work independently and within a cross-functional team

• Communicate project updates and issues in timely manner and strives for continuous improvement.

• Participates in and leads improvement projects, as applicable.

• Routine laboratory management tasks including those related to equipment maintenance, safety and GMP compliance

• Strong focus on clients and end-user.

Position Qualifications:

Education Minimum Requirement:

• Bachelor of Science degree in Biology, Chemistry, or other related disciplines with at least two (2) year of laboratory experience in a cGMP environment

• Master of Science degree in Biology, Chemistry, and other related disciplines with one (1) year of laboratory experience in a cGMP environment.

Required Experience and Skills:

• Ability to independently follow procedures and work within a cross-functional team

• Ability to think critically and learn new techniques

• Understanding and experience with analytical troubleshooting in biologic assay development or quality.

• Understanding and experience with bioassays, specifically immunoassays (such as ELISA, EIA) or other binding-based assay technology and/or biochemistry techniques.

• Experience with HPLC and CE.

• Excellent interpersonal and communication skills, oral and written.

​Preferred Experience and Skills:

• Statistical analysis experience with familiarity with JMP.

• Experience with electronic lab notebooks, LIMS systems, and electronic log systems

• Organization and project management abilities.

• Experience working in a Good Manufacturing Practices (cGMP) laboratory environment.

• Knowledge of quality and compliance guidelines and manufacturing processes.

• Technical aptitude and desire to learn new equipment and associated software to enable digital build capabilities.

• Effective planning and time management skills.

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

$77,700.00 - $122,300.00

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

Required Skills:

Accountability, Accountability, Assay Development, Cell-Based Assays, Compound Management, Cross-Functional Teamwork, Data Preparation, Detail-Oriented, Environmental Regulatory Compliance, Global Manufacturing, GMP Compliance, Immunoassays, Immunogenicity Assays, Improvement Projects, Lab Equipment Maintenance, Laboratory Operations, Management Process, Manufacturing Processes, Method Validation, Production Quality Control, Project Management, Quality Control Management, Quality Improvement, Recordkeeping, Research Development {+ 3 more}

Preferred Skills:

Job Posting End Date:

09/26/2025

*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.