Associate Principal Scientist, Preclinical Development

Merck & Co.; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck is seeking a Senior Scientist to lead biologics sterile product development, including formulation and process design for non-oral dosage forms. The role emphasizes experimental design, data analysis, and cross-functional collaboration to ensure scalable, compliant drug products from late-stage development to regulatory submission.

The candidate will mentor scientists, drive technology advancement, and support internal and external manufacturing, with responsibilities spanning project

Qualifications

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 3 years relevant industry experience.
• B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.

Responsibilities

• Lead/ contribute towards biologics sterile product development through experimental design and data analysis.
• Support early and late-stage development including robust drug product composition and scalable processes.
• Lead and mentor scientists; interface with stakeholders and drive milestones.
• Lead and sponsor process scale-up and tech transfers at external sites.
• Advance science and technology through publications, patents, and presentations.

Skills

Biologics process development

Formulation development

Design of Experiments (DOE)

Drug delivery

Regulatory filings

Project leadership

Scientific collaboration

Technical expert

Education

Ph.D. in Chemical Engineering

Ph.D. in Biomedical Engineering

Job description

Job Description

The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products.

Primary duties

• Lead/ contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of experimental plans and data analysis.


• Support both early and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.


• Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation.


• Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.


• Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals.


• Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.


• Leads project activities at external manufacturing sites including tech transfers.


• Enhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations.


• Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others.

Education Minimum Requirement

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 3 years relevant industry experience.


• B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.

Required Experience and Skills

• Experienced in biologics process development and characterization particularly for late-stage programs.


• Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process.


• Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas.


• Has broad knowledge of formulation science and in depth-knowledge in multiple areas, including core understanding of the drug development process.


• Track record of working effectively with team-members of diverse skill sets and backgrounds.


• Strong verbal and written communication skills.


• The candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/ characterization reflected through industry experience and external publications/ patent.

Preferred Experience and Skills

• Prior experience leading development projects at an enterprise level.


• Capable of mentoring individuals in a peer-to-peer fashion and as a technical mentor.


• Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology.


• Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies.


• Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.


• Prior experience with process scale-up, modeling, regulatory filings and/or driving key capability evaluation/ build would be highly preferred.

Required Skills: Biologics, Biologics, Biotechnology, Chemical Engineering, Clinical Development, Design of Experiments (DOE), Detail-Oriented, Drug Development, Drug Formulations, External Manufacturing, Formulation Development, Interpersonal Relationships, Leading Project Teams, Manufacturing Documentation, Manufacturing Strategies, Matrix Management, Molecular Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Pharmaceutical Product Development, Pharmaceutical Research, Pharmaceutical Sciences, Pharmaceutics, Physical Characterization {+ 4 more}

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. If you need an accommodation during the application or hiring process.

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.

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

10/13/2026

Requisition ID

R418667

Salary Range

$142,400.00 - $224,100.00

Compensation and Benefits

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.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.