Senior Scientist – Drug Product Development

Senior Scientist I – Drug Product Development

Join an innovative pharmaceutical organization where you'll play a pivotal role in advancing therapies from early development through commercialization. We're looking for a collaborative scientist and technical leader with expertise in drug product development to drive formulation strategies, lead cross-functional teams, and deliver high-impact CMC programs. If you're passionate about solving complex scientific challenges and bringing new medicines to patients, this is an opportunity to make a meaningful impact.

• Lead drug product development activities across preclinical, clinical, and commercial programs for small molecules, peptides, and oligonucleotides.
• Develop and execute formulation strategies, including solid oral dosage forms, process optimization, technology transfer, and manufacturing support.
• Serve as the technical lead for cross-functional CMC teams, partnering with Analytical Development, Drug Substance, Manufacturing, Quality, Regulatory, Packaging, Engineering, and external manufacturing organizations.
• Drive project execution by managing timelines, identifying risks, tracking milestones, and ensuring successful delivery of program objectives.
• Provide scientific oversight for formulation development, manufacturing, technology transfer, and process optimization activities performed internally and with CDMOs.
• Contribute to CMC documentation, regulatory submissions, development reports, and technical reviews.
• Mentor junior scientists while fostering collaboration, innovation, and technical excellence across multidisciplinary teams.

• Master's degree in Pharmaceutics, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related scientific discipline required. Ph.D. preferred.
• 7–10+ years of pharmaceutical or biotechnology industry experience in drug product development, formulation development, or CMC, with a proven track record of leading cross-functional programs.
• Hands-on experience with solid oral dosage form development, including pre-formulation and formulation of tablets, capsules, and oral solutions.
• Strong expertise in formulation development, process optimization, technology transfer, manufacturing support, and CMC activities.
• Experience leading multidisciplinary teams and collaborating across functions including Analytical Development, Manufacturing, Quality, Regulatory, and external CDMOs/CMOs.
• Experience supporting regulatory submissions, CMC documentation, and technical reports.
• Working knowledge of GMP regulations and pharmaceutical development.
• Excellent leadership, communication, project management, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.

• Experience with parenteral formulation development and fill/finish operations.
• Knowledge of small molecules, peptides, oligonucleotides, biologics, or gene therapy products.
• Experience supporting technology transfer, process validation, and commercial manufacturing.
• Familiarity with analytical techniques including HPLC, SEC, ion exchange chromatography, DSC, UV spectroscopy, particle size analysis, DLS, and stability testing.

This is a highly visible leadership opportunity where you'll influence product development strategy from concept through commercialization while working alongside talented scientists and technical leaders. You'll have the opportunity to solve complex scientific challenges, lead impactful programs, and help bring innovative therapies to patients in a collaborative, fast-paced environment.