Associate Principal Scientist, Mixed Modality Product Development

MSD • Rahway, NJ

1d

About The Position

The Mixed Modalities team within Sterile Product Development develops parenteral dosage forms—including injections, implants, inhaled products, and ocular products—for small, intermediate, and large molecules from preclinical toxicology through commercialization. The team develops robust compositions, primary packaging and devices, and scalable processes through fundamental understanding and characterization, while protecting product stability, safety, efficacy, and delivery. It uses experimental design, analytical tools, and predictive approaches to inform molecule, formulation, and process selection.

The Associate Principal Scientist will develop parenteral drug products across modalities, including small molecules, peptides, proteins, antibody-drug conjugates, and other biologics. The role includes technical and strategic leadership in integrated, multidisciplinary teams; formulation and process development; support for early- and late-stage candidates and regulatory filings; and project activities at external manufacturing sites, including technology transfers. The scientist will also mentor colleagues, contribute to innovation and organizational objectives, and advance the company's professional and scientific profile through patents, presentations, publications, and professional activities.

Requirements

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related discipline, with at least 4–5 years of relevant industry experience; alternatively, a B.S. or M.S. in Engineering, Pharmaceutical Sciences, or a related discipline with at least 8 years of relevant industrial experience.
• Experience in biologics process development and characterization, particularly for late-stage programs.
• Ability to lead formulation development in matrix teams and define robust formulations and manufacturing processes.
• Recognized technical expertise and scientific contribution, with the ability to identify and develop innovative ideas.
• Broad knowledge of formulation science and in-depth knowledge in multiple areas, including a core understanding of the drug development process.
• Track record of working effectively with team members from diverse disciplines and backgrounds.
• Strong verbal and written communication skills.
• Strong product development, regulatory filing, drug delivery, complex formulation, and process development or characterization track record, demonstrated through industry experience and external publications or patents.
• Ability to collaborate in a fast-paced, integrated, multidisciplinary team; take initiative; manage multiple tasks; and communicate and work effectively with others.

Nice To Haves

• Deep understanding of one or more of surface science, colloid science, particle engineering, antibody-drug conjugates, or high-concentration formulations.
• Prior experience leading development projects at an enterprise level.
• Ability to mentor individuals peer-to-peer and as a technical mentor.
• Recognition as a subject matter expert in at least one drug delivery or manufacturing technology.
• Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through development and optimization of novel production technologies.
• Interest in building new capabilities through evaluating new technologies and hands-on optimization of existing technologies.
• Prior experience with process scale-up, modeling, regulatory filings, or driving key capability evaluation or development.

Responsibilities

• Lead or contribute to innovative approaches for biologics sterile product development, including experimental design, execution of experimental plans, and data analysis.
• Support early- and late-stage development candidates by screening and developing robust drug product compositions and scalable processes.
• Develop and characterize primary packaging and compatibility for processing and administration, and support regulatory filings.
• Build fundamental knowledge of drug products and complete key milestones and laboratory and regulatory documentation.
• Provide strategic and technical leadership on program development teams, interface with stakeholders, and collaborate across functions to achieve milestones.
• Lead and champion organizational strategic and innovation objectives.
• Mentor scientists and contribute technical expertise in a multidisciplinary team environment.
• Lead project activities at external manufacturing sites, including technology transfers.
• Advance the company's professional image and competitive advantage through patents, presentations, publications, and professional activities.
• Contribute to science and technology development, technical and business strategic improvements, and business process innovations.
• Maintain awareness of relevant current and emerging technologies and capabilities, and share this knowledge with others.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree