Job Description
Scientist (R2) Bioassay
North American GMP Operations, Rahway, NJ
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 diverse 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 actively seeking an enthusiastic individual to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) Good Manufacturing Practices (GMP) Operations, to support bioassay analysis, including ELISA and cell-based methods. In this role, the selected candidate will be responsible for method optimization, phase-appropriate validation, early and late-stage transfers, SoftMax Pro template validation, cell line maintenance, analytical life cycle management, and release and stability testing. The successful candidate must be able to work in a fast-paced, multidisciplinary environment and will play a pivotal role supporting Biologics to advance commercialization efforts.
The incumbent will collaborate closely with various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline.
Responsibilities
Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools.
- Validate and implement analytical methods to support release and stability testing of clinical trial materials.
- Support critical reagent qualifications and SoftMax pro template validation activities.
- Document activities in a detailed and organized manner and follow SOPs.
- Author and review technical documents.
- Complete assigned work within established project timelines.
- Support GMP compliance and continuous improvement of laboratory operations.
- Manage laboratory supplies and critical reagent inventories.
- Additional responsibilities as assigned to support the evolving needs of the department.
Experience and Skills
Required
- 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, master's degree preferred.
- Additional responsibilities as assigned to support the evolving needs of the department.
- Experience with mammalian cell culture and ELISAs.
- Additional responsibilities as assigned to support the evolving needs of the department.
- Document activities in a detailed and organized manner following SOPs.
- Ability to manage work to meet project timelines.
- Capability to work independently with minimal supervision.
- Ability to identify and resolve common technical issues.
- Effectively communicate, collaborate, and engage with others.
- Agile learner who is self-motivated with a positive attitude.
- A willingness to occasionally work irregular hours, including evenings and weekends, as needed.
Preferred
- GMP experience is preferred.
- Experience with LIMS, SoftMax Pro, electronic notebook, or other data analytics platforms.
- Knowledge of assay validation requirements is highly preferred.
- Understanding of cGxP operation, USP, EP, ICH, and FDA guidelines.
- Experience with SoftMax Pro template creation is preferred.
- Familiarity with deviation management and change control processes.
- Experience with method development, qPCR, capillary electrophoresis, chromatographic separations and/or compendial methods is desirable.
#AR&D
#eligibleforERP
**Required Skills: **
Biochemistry, Cell-Based Assays, Cell Cultures, Collaborative Communications, Fast-Paced Environments, Good Manufacturing Practices (GMP), Immunoassays, Immunochemistry, Interpersonal Relationships, Laboratory Techniques, Maintenance of Cell Lines, Mammalian Cell Culture, Real Time Polymerase Chain Reaction (qPCR), Self Motivation, Standard Operating Procedure (SOP) Writing
**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
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:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
05/11/2026
***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. **