Scientist, Analytical R&D

Job Description

Join a dynamic team dedicated to advancing lifesaving and life enhancing medicines. Our team is deeply committed to providing exceptional scientific oversight, supporting our Company's portfolio from candidate selection through market authorization. At our company, we proudly continue to build upon a legacy of groundbreaking innovation with ethics and integrity. Powered by diverse perspectives, we work as one to deliver transformative medicines with integrity and transparency.

We are seeking an enthusiastic Scientist (R2) to join our Rahway, NJ team in Biologics Analytical R&D GMP Operations. This role executes analytical testing for raw materials and supports instrument qualification to enable timely, compliant release of raw materials used in clinical production. The successful candidate will thrive in a fast-paced, multidisciplinary environment and play a key role in advancing biologics commercialization.

The incumbent will partner with stakeholders such as Technical Operations, Manufacturing, Analytical Development, Large Molecule Assay Validation, Quality Assurance, and CMC Regulatory Affairs to resolve technical issues, provide scientific guidance across the product lifecycle, and deliver on program commitments.

Responsibilities

• Ensure adherence to GMP requirements and drive continuous improvement of laboratory processes.
• Execute advanced and routine analytical methods to support raw material testing and release.
• Complete assigned work within established project timelines.
• Serve as an SME for raw materials testing, practices and procedures at our Biologics Development Center in Rahway, NJ and North Wales, PA labs.
• Manage laboratory equipment, supplies, and critical reagent inventories.
• Support instrument qualification (IQ/OQ/PQ) activities for analytical equipment.
• Author and review technical documentation, including content that supports regulatory submissions.
• Support•biologics•registrations,•product•launches, and troubleshooting activities.•
• Support compliance audits, inspection activities, investigations, and corrective/preventative actions.•
• Additional•responsibilities as assigned to support the evolving needs of the department.

Qualifications

B.A./B.S. in Biology, Biochemistry, or a related scientific field with a minimum of 3 years of relevant experience (analytical development, validation, and/or quality control), or an M.S. degree with relevant experience.

Experience and Skills

Required

• At least 1 year of experience working in a GMP environment.
• Experience with analytical methods such as spectroscopy (including FTIR and Raman), UV spectrophotometry, and compendial procedures (such as pH and conductivity measurements).
• Proficiency with data analytics.
• Demonstrated understanding of 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 across teams.
• Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning.
• A willingness to occasionally work irregular hours (including evenings and weekends) as needed.

Preferred

• Solid background in GMP and a thorough grasp of data integrity principles (ALCOA+) for documentation are highly preferred.
• Familiarity with testing raw materials in pharmaceutical or related environments.
• Skilled in using LIMS, Empower, electronic notebooks, and various data analytics platforms.
• Well-versed in USP, EP, ICH, and FDA guidelines.•
• Experienced in handling deviation management and change control processes.
• Proficient in method development and regulatory submission processes.

Required Skills:
Adaptability, Analytical Development, Analytical Method Development, Cell-Based Assays, Good Manufacturing Practices (GMP), Immunoassays, Interpersonal Relationships, Laboratory Information Management System (LIMS), Laboratory Techniques, Mammalian Cell Culture, Real Time Polymerase Chain Reaction (qPCR), Self Motivation, Standard Operating Procedure (SOP) Writing, Technical Writing, Troubleshooting

Preferred 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

The salary range for this role is
$87,300.00 - $137,400.00

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 .

You can apply for this role through (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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
no

Job Posting End Date:
05/20/2026
*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.

Requisition ID: R398159