Senior Scientist, Engineering

Caraway Therapeutics; Rahway (NJ); Presencial; USD 117.000 - 184.000; Jornada completa

Descripción de la vacante

Caraway Therapeutics, Inc. is seeking a Senior Scientist, Engineering in Rahway, NJ to lead development and transfer of enzyme-based manufacturing processes for late-stage small molecule programs.

You will work hands-on in fermentation and downstream processing with a focus on robust process characterization and scale-up. The role emphasizes mentoring, quality risk management, and regulatory familiarity, with opportunities to contribute to commercial-scale production and continuous improvement

Formación

• PhD in Chemical Engineering, Bioprocess Engineering, Biological Engineering, Synthetic Biology, or related field.
• 3 years of experience in chemical/pharma process development.
• Experience in microbial fermentation and downstream processing and scale-up.

Responsabilidades

• Develop safe and robust manufacturing processes for late-stage projects.
• Optimize enzyme manufacturing process control across scales.
• Mentor junior staff and enhance lab capabilities.
• Transfer technologies to commercial manufacturing.
• Apply QRM and DOE for experiments and risk assessments.
• Conduct hands-on bench and kilo-lab work; ensure cGMP/GDP compliance.

Conocimientos

Bioprocess Engineering

Fermentation

Design of Experiments

Process Development

Quality by Design

Technology Transfer

cGMP

GMP

Regulatory Submissions

DOE

Vaccine Development

Educación

PhD in Chemical Engineering or related field

3 years experience in chemical/pharma process development

Herramientas

Quality Risk Management tools

Statistical design tools

Descripción del empleo

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

Preferred Skills:

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.

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 primary location for this posting is:

USA - New Jersey - Rahway

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

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

$117,000.00 - $184,200.00

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.

Additional location(s) Compensation Information:

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.