Job Description
We invite individuals who possess a deep passion for promoting lifesaving and life-enhancing products to join our dynamic team. Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our company's extensive range of products from candidate selection to market authorization. At our company, we proudly continue to build upon a legacy of groundbreaking innovation while steadfastly upholding the highest standards of ethics and integrity. With a workforce representing a multitude of languages and cultures, we stand unified in our collective mission to deliver revolutionary medicines and products with integrity and transparency.
We are seeking an enthusiastic Scientist to join our Biologics AR&D GMP Operations team in Rahway, NJ. This position involves supporting separation assays and compendial methods, maintaining GMP readiness, and ensuring consistent business operations. Main responsibilities include method optimization, validation, analytical transfers, life cycle management, and conducting release and stability tests. The ideal candidate will excel in a dynamic, multidisciplinary environment and contribute significantly to the commercialization of Biologics. The analyst will maintain laboratory GMP compliance by training staff, improving processes, preparing for audits, and overseeing sample inventory and shipments.
The incumbent will work with stakeholders such as Technical Operations, Manufacturing, Analytical Development, Large Molecule Assay Validation, Quality Assurance, and CMC Regulatory Affairs to solve technical issues, offer scientific guidance throughout development, and manage deliverables to advance the pipeline.
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).
- Support biologics registrations, product launches, and troubleshooting activities.
- Author and review technical documents.
- Act as compliance/Quality SME to support preparation for audits and inspections.
- Provide oversight for lab activities to maintain GMP requirements and inspection ready status.
- Provide SME guidance for investigation/CAPAs and change control.
- Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes.
- Manage laboratory equipment, laboratory supplies, and critical reagent inventories.
- Complete assigned work within established project timelines.
- 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 1+ year of relevant experience.
Required
Experience and Skills
- At least 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 analysis.
- 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, as needed.
- Willingness to travel to PA site 25% of the time.
Preferred
- Demonstrated understanding of deviation management and change control processes, paired with proficient authoring capabilities.
- Familiarity with regulatory guidelines and GMP laboratory controls, including audit and inspection support.
- Strong organizational skills, with knowledge of sample inventory management systems and related procedures.
- Technical proficiency in compendial testing methods such as analysis of visible and sub-visible particles, pH, osmolality, color, and clarity.
- Established familiarity with USP, EP, ICH, and FDA regulations.
- Proficient in utilizing LIMS, Empower, electronic notebooks, and other data analytics platforms.
ARD
Required Skills
Capillary Electrophoresis (CE), Capillary Isoelectric Focusing (cIEF), GMP Compliance, Good Manufacturing Practices (GMP), High-Performance Liquid Chromatography (HPLC), Laboratory Information Management System (LIMS), Laboratory Techniques, Separation Techniques, Ultra Performance Liquid Chromatography (UPLC)
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.
Requirements
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
$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 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:
Domestic
VISA Sponsorship
No
Travel Requirements
25%
Flexible Work Arrangements
Not Applicable
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
potent compounds
Job Posting End Date
03/17/2026
- 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:R388283
