Associate Principal Scientist, Mixed Modality Product Development

Merck • Rahway, NJ

2d • $142,400 - $224,100

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 studies through commercialization. The team selects robust compositions, primary packaging and devices, and scalable processes based on fundamental understanding and characterization, while protecting product stability, safety, efficacy, and delivery. Development work uses experimental design, advanced analytical tools, and predictive approaches to guide molecule, formulation, and process selection and to translate preclinical candidates into non-oral drug products.

The Associate Principal Scientist will develop parenteral drug products across modalities including small molecules, peptides, proteins, antibody-drug conjugates, and biologics. The role involves leading or contributing to innovative biologics sterile-product development, supporting early- and late-stage candidates, and providing strategic and technical leadership on multidisciplinary program teams. The scientist will build fundamental product knowledge, support milestones and regulatory documentation, lead project activities at external manufacturing sites including technology transfers, mentor scientists, and advance technical, scientific, and business innovations. The role also contributes to the organization’s professional standing and competitive advantage through patents, presentations, publications, and professional activities.

Requirements

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related discipline and a minimum of 4–5 years of relevant industry experience; alternatively, a B.S. or M.S. in Engineering, Pharmaceutical Sciences, or a related discipline and a minimum of 8 years of relevant industrial experience.
• Experience in biologics process development and characterization, particularly for late-stage programs.
• Ability to lead formulation development activities in matrix-team environments and define robust formulations and manufacturing processes.
• Recognized technical expertise and scientific contributions, with a demonstrated 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 backgrounds and skill sets.
• Strong verbal and written communication skills.
• Strong track record in product development, regulatory filings, drug delivery, or complex formulation and process development and characterization, reflected through industry experience and external publications or patents.
• Ability to take initiative, manage multiple tasks, communicate and collaborate effectively, and demonstrate motivation to learn and contribute.

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.
• Desire to build new capabilities by 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.
• Skills listed in the posting include 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, and toxicology.

Responsibilities

• Lead or contribute to innovative approaches for biologics sterile-product development through experimental design, execution of experimental plans, and data analysis.
• Support early- and late-stage development candidates, including screening and developing robust drug-product compositions and scalable processes.
• Develop primary packaging and characterize compatibility for processing and administration.
• Support regulatory filings.
• Build deep fundamental knowledge of drug products to 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 aligned with organizational goals.
• 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.
• Advance 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, and compassionate and sick days.
• Eligible for an 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