Associate Principal Scientist, Mixed Modality Product Development

About the role

The Mixed Modalities team within Sterile Product Development is responsible for developing parenteral 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.

We are seeking a highly motivated candidate for the position of Associate Principal Scientist (R4) focused on developing parenteral drug products across a range of modalities (small molecule, peptides, proteins, antibody-drug conjugates, and biologics). The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

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 4-5 years relevant industry experience.

OR

• 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

• Deep understanding of one or more of the following: surface science, colloid science, particle engineering, ADC and/or high concentration formulations
• 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, Cell Line Development, Design of Experiments (DOE), Downstream Process Development, Drug Delivery, Drug Product Development, Expression Vectors, Molecular Biology, Particle Engineering, Pharmaceutical Formulations, Pharmaceutical Process Development, Product Formulation, Technology Transfer, Toxicology

Preferred Skills

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US and Puerto Rico Residents Only

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• The primary location for this posting is: USA - New Jersey - Rahway

Pay and benefits

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

The salary range for the primary location of this role is

$142,400.00 - $224,100.00

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.

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.

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: 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: 11/28/2026

Additional information

*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.