Senior Scientist, Parenteral Drug Product Development

What You'll Do

• Design and execute formulation and process development studies supporting preclinical, clinical, and commercial drug product development.
• Lead development of sterile parenteral drug products, including formulation optimization, manufacturing process development, and technology transfer.
• Provide technical support during GMP manufacturing campaigns, engineering runs, process validation, PPQ, and commercial manufacturing.
• Lead studies supporting process characterization, process validation, manufacturing robustness, and lifecycle management.
• Collaborate closely with drug substance, analytical development, device engineering, manufacturing sciences, quality, regulatory, and external manufacturing organizations.
• Develop scientifically sound strategies for primary container closure systems, including vials, prefilled syringes, and other advanced delivery systems.
• Support selection, qualification, and compatibility assessment of manufacturing equipment, single-use systems, filters, and container closure systems.
• Prepare and coordinate drug product supply for nonclinical and clinical studies.
• Author technical reports, development protocols, validation protocols, regulatory submission documents, responses to health authority questions and contribute to global regulatory submissions.

Qualifications

You have a strong understanding of parenteral drug product development and manufacturing. You are a collaborative and scientifically curious professional who enjoys solving complex technical challenges and advancing innovative therapies. You thrive in a fast-paced, matrixed environment where you can independently drive development activities while partnering across functions to achieve shared goals. You communicate effectively, exercise sound scientific judgment, and are motivated by delivering high-quality solutions that support the development of novel parenteral drug products. Your adaptability, initiative, and commitment to excellence make you a valuable contributor to a growing and evolving development organization.

Education Requirements

• Ph.D. in Chemical Engineering, Materials Science, Pharmaceutical Sciences, Pharmaceutics, Analytical Chemistry or related fields with 4+ years of experience in pharmaceutical or biotech settings.
• OR M.S. degree with 8+ years of relevant experience
• OR B.S. degree with 10+ years of relevant experience

Required Skills

• Demonstrated experience with sterile drug product development and parenteral formulations preferably with hands-on experience with oligonucleotide, peptide, antibody, or conjugated therapeutics.
• Strong understanding of drug product manufacturing process operations including mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
• Prior experience working in a biopharmaceutical product development environment or working with CDMOs and familiarity with GMP guidelines.
• Experience conducting technical risk assessments using quality-by-design principles.
• Experience with process validation, PPQ, engineering batches, technology transfer, and authoring technical reports, validation documents, and regulatory submissions including IND, IMPD, NDA and responses to health authority's questions.
• Experience in analytical and characterization techniques used for characterization of sterile drug products.
• Demonstrated ability to independently lead technical initiatives, solve complex scientific problems, and effectively collaborate across multidisciplinary teams.

Preferred Skills

• Experience with formulation development of proteins, antibodies, antibody-drug conjugates, or other complex biologics is highly desirable.
• Experience in developing and analyzing drug delivery systems and targeted conjugate molecules is a plus.
• Knowledge of statistical software, design or experiment programming and general visualization of sophisticated data sets is a plus.