Job Description

We are seeking a Scientist (R2) to join our Biologics Analytical Research & Development (AR&D) GMP Operations team in North Wales, PA, part of the West Point campus footprint. The ideal candidate brings strong technical judgment, GMP discipline, and cross-functional collaboration skills to support biologics development and commercialization.

The successful candidate will execute testing of compendial and separations-based analytical methods, including HPLC, UPLC, CE, and iCIEF.  The incumbent will collaborate with Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, CMC Regulatory Affairs, and external stakeholders to validate analytical methods and support release and stability testing.

Responsibilities

• Validate and implement analytical methods to support release and stability testing of clinical materials.

• Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP).

• Act as subject matter expert (SME) across various franchises and analytical platforms.

• Support biologics registrations, product launches, and troubleshooting activities.

• Support compliance audits, inspection activities, and investigation/CAPAs.  

• Author and review technical documents.

• Complete assigned work within established project timelines.

• Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes.

• Manage laboratory equipment, laboratory supplies and critical reagent inventories.

• Support instrument qualification activities, including IQ/OQ/PQ, as needed.

• Additional responsibilities as assigned to support the evolving needs of the department.

Qualifications

• Minimum of a B.A./B.S. degree in biology, biochemistry, or related scientific field with 3 years of relevant experience in analytical development, validation, and/or quality control, or M.S. degree with a minimum of 1 year of relevant experience.

Experience and Skills

Required

• Minimum of 1 year experience working in a GMP environment

• Experience with separation techniques such as HPLC, UPLC, CE, iCIEF, or other advanced technology.

• Proficiency with data analytics.

• Understanding and adherence to ALCOA principles for documentation.  

• Strong organizational skills and ability to manage work to meet project timelines.

• Capability to work independently with minimal supervision.

• Ability to identify and resolve common technical issues.

• Effectively engage, communicate, and collaborate with others.

• Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning.

• A willingness to occasionally work irregular hours, including evenings and weekends, to support business needs.

​Preferred

• Technical expertise with compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity.

• Knowledge of USP, EP, ICH, and FDA regulations.

• Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms. 

• Knowledge of deviation management and change control processes.

ARD

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Preferred Skills:

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The salary range for this role is

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. 

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