Senior Scientist, Engineering

Merck & Co.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co. in Rahway, NJ, is seeking a Senior Scientist, Engineering to develop and de-risk safe, robust manufacturing processes for late-stage small molecule projects.

You will leverage expertise in microbial fermentation, downstream processing, and technology transfer to support global manufacturing and regulatory filings. You will mentor staff, work in a highly collaborative environment, and ensure compliance with cGMPs, GDPs, and quality systems while advancing internal capabilities and

Qualifications

• PhD in Chemical Engineering or related field required.
• 3 years of experience in chemical/pharmaceutical process development.
• Experience with microbial fermentation and downstream processing; scale-up knowledge.
• Ability to lead experimental programs addressing design, robustness, and productivity.
• Experience with process scale-up and technology transfer from lab to pilot/factory.
• Mentor staff and collaborate across a cross-functional team.
• Strong communication, organization, and writing skills.

Responsibilities

• Develop safe, robust manufacturing processes via characterization, technology transfer, validation, and supply support for late-stage projects in the small molecule pipeline.
• Optimize enzyme manufacturing process control across scales with microbial fermentation and downstream processing.
• Mentor junior staff and enhance laboratory capabilities for fermentation and downstream processing.
• Support transfer of technologies to commercial manufacturing.
• Apply Quality Risk Management and DOE-based experimental design.
• Conduct hands-on lab and kilo-lab experiments.
• Ensure compliance with cGMPs and GDPs and participate in risk assessments and deviations.

Skills

Biocatalysis

Fermentation

Bioprocess Engineering

cGMP Regulations

Quality by Design

Technology Transfer

Process Design

Process Development

Process Scale Up

Regulatory Submissions

GMP

Small Molecule Drug Development

Vaccine Development

Education

PhD in Chemical Engineering, Bioprocess Engineering, Biological Engineering, Synthetic Biology, or a related field

Job description

Job Description

We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our Chemical Commercialization Technology (CCT) department, part of our manufacturing division, and be part of a highly collaborative environment that provides substantial technical responsibility and leadership of internal and external work.

The Chemical Commercialization Technology (CCT) department, which is part of our Company's Manufacturing Division, is seeking self-motivated individuals who are looking for an opportunity to work in a highly collaborative environment that provides substantial technical responsibility and leadership of internal and external work.

The Senior Scientist, Engineering position leverages scientific/technical experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small molecule pipeline. Given the significant role of biocatalysis and enzymes in the portfolio, the ideal candidate should have a specific expertise in microbial fermentation and downstream processing and is expected to draw on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales. The successful candidate will play a pivotal role in developing internal technical capabilities via mentoring junior staff and enhancing fermentation and downstream processing laboratory capabilities, in addition to supporting transfer of technologies to commercial manufacturing. The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands‑on experimentation at the laboratory bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities. The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).

Responsibilities

• Develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing, and supply support of late-stage projects in the small molecule pipeline.
• Optimize and fully characterize the enzyme manufacturing process control strategy across different scales, leveraging expertise in microbial fermentation and downstream processing.
• Mentor junior staff and enhance fermentation and downstream processing laboratory capabilities.
• Support the transfer of technologies to commercial manufacturing.
• Utilize Quality Risk Management methodologies and tools for statistical design of experiments.
• Conduct hands‑on experimentation at the laboratory bench and kilo lab scales.
• Ensure safety and quality compliance, including following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).

Qualifications

Required

• PhD in Chemical Engineering, Bioprocess Engineering, Biological Engineering, Synthetic Biology, or a related field from an accredited college/university.
• Three years (3) of experience required in chemical, pharmaceutical, large molecule, or vaccine process development.
• Experience and knowledge in microbial fermentation and downstream process development and optimization, as well as process scale‑up and scale‑down.
• Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness, and productivity.
• Experience with process scale‑up and technology transfer, moving from laboratory to pilot plant or factory.
• Ability to mentor technical staff in the laboratory and through data analysis.
• Highly effective communication and collaboration skills.
• Good organizational, interpersonal, writing, and time management skills.
• Lead and operate within a cross‑functional process development team.

Preferred

• Experience performing lab‑based research/process development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work‑up, and crystallization.
• Experience leading file authoring, validation planning, and execution.
• Experience guiding internal/external technical discussions.
• Familiarity with statistical design and analysis tools.
• Familiarity with concepts and application of current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance/drug product development and production, e.g., in a pilot and/or factory setting.
• Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design (QbD) principles.
• Experience supporting/writing regulatory filings.

Required Skills

• Adaptability
• Biocatalysis
• Biological Engineering
• Bioprocess Engineering
• Bioreactors
• cGMP Regulations
• Chemical Engineering
• Chromatographic Techniques
• Crystallizations
• Design of Experiments (DOE)
• Detail‑Oriented
• Fermentation
• Good Manufacturing Practices (GMP)
• Manufacturing Processes
• Process Design
• Process Development (PD)
• Process Optimization
• Process Scale Up
• Quality by Design
• Regulatory Submissions
• Small Molecule Drug Development
• Small Molecule Synthesis
• Synthetic Biology
• Technology Transfer
• Vaccine Development

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.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

11/17/2026

*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

R425003

Where required by law, the compensation range for this role is provided below.

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.

The salary range for the primary location of this role is:

$117,000.00 - $184,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .