Job Description

Job Summary:

We are actively seeking an enthusiastic individual to join our Rahway, NJ team as a Senior Scientist (R3) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support 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, 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 biologics methods to support release and stability testing of clinical materials.
• Support critical reagent qualifications and SoftMax pro template validation activities.
• Act as subject matter expert (SME) across various franchises and analytical platforms.
• Support biologics registrations, product launches, and troubleshooting activities.
• Develop and manage project timelines and deliverables.
• Support compliance audits, inspection activities, and investigation/CAPAs. 
• Advance strategic initiatives across matrixed teams.
• Author and review technical documentation including regulatory submissions.
• Additional responsibilities as assigned to support the evolving needs of the department.

Qualifications:

• Ph.D. in biology, biochemistry or related field or M.S. with a minimum of 3 years of relevant experience or B.S. with a minimum of 7 years of relevant experience.   

Experience and Skills:

Required

• Deep technical expertise with immunoassays and/or cell-based potency methods.
• Proficiencies with mammalian cell culture and ELISAs.
• Strong organizational skills with proven ability to manage timelines and deliverables.
• Ability to pro-actively identify and communicate risks.
• Demonstrated capability of finding innovative solutions to technical issues.
• Capability to work independently and within a matrixed team.
• Effective communication (oral and written) and leadership skills.
• Strong interpersonal skills with adeptness to lead by influencing others.
• Self-motivated with a positive attitude and proven performance record.
• A willingness to occasionally work irregular hours, including evenings and weekends, as needed. 

​Preferred

• GMP experience is highly preferred.
• Experience with LIMS, SoftMax Pro, electronic notebook, and/or other data analytics platforms. 
• Knowledge of cGxP operation, USP, EP, ICH, and FDA guidelines. 
• Experience with analytical method validation and life cycle management.
• Deviation management and change control processes.
• Experience with method development or regulatory submissions.
• Experience with SoftMax Pro template creation is highly preferred.
• Experience with residual assays, qPCR, capillary electrophoresis, chromatographic separations or compendial methods is desirable.

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Required Skills:

Preferred Skills:

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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:

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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.

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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. 

Employee Status:

Relocation:

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