Associate Principal Scientist, Preclinical Development

MSD; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an experienced leader in biologics sterile product development to drive late-stage formulation and process development for non-oral dosage forms, including injectables and implants.

You will collaborate across functions to design robust drug product strategies and ensure scalable manufacturing. The role emphasizes technical leadership, strategic planning, and documentation for regulatory filings, with opportunities to mentor scientists and contribute to

Qualifications

• Ph.D. or equivalent with relevant industry experience in biologics.
• Experience leading formulation development for late-stage programs.
• Ability to drive development with regulatory awareness.

Responsibilities

• Lead/ contribute to innovative approaches for biologics sterile product development.
• Guide formulation development activities in matrix teams to define robust processes.
• Demonstrate technical leadership on program development teams and drive milestones.
• Mentor scientists and support tech transfers at external sites.
• Contribute to patents, publications and regulatory filings.

Skills

Biologics

Formulation development

Design of Experiments

Regulatory filings

Team leadership

Communication

Education

Ph.D. in Chemical Engineering or Biomedical Engineering or Pharmaceutical Sciences

B.S./M.S. in Engineering or Pharmaceutical Sciences

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.

EligibleforERP

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 Products, Pharmaceutical Research, Pharmaceutical Sciences, Pharmaceutics, Physical Characterization {+ 4 more}

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.

Learn more about your rights, including under California, Colorado and other US State Acts

Salary

The salary range for this role is $142,400.00 - $224,100.00

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.

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.

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.

Employment Details

• 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*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.