Principal Scientist, Mixed Modalities, Sterile Product Development Full-time

Principal Scientist – Mixed Modalities, Sterile Product Development

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 Principal Scientist (R5) 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

• Be a seasoned formulation scientist responsible for the design and development of sterile products across injectable, implantable, ophthalmic, and inhaled dosage forms.
• Provide active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones.
• 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.
• Collaborate with key stakeholders across the organizations (Research Division / Manufacturing Division) to drive key capability evaluations / builds and champion strategic and innovation objectives aligned with organizational goals.
• Maintain a strong network internally and across the external academic and regulatory community and build collaborations across internal company departments and key stakeholders.
• Mentor and/or supervise a small group of scientists to perform the above duties and to develop the above capabilities.

Minimum Education Requirements

• Ph.D. with 8+ years industry experience, M.S. with 10+ years, or B.S. with 14+ years with a degree in Chemical / Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related discipline.

Required Experience and Skills

• Deep drug product development expertise with exposure to all stages and aspects of development (preclinical, clinical, and commercial) and cGMP industrial background.
• Demonstrated scientific leadership and a strong track record in parenteral formulation and process development reflected through industry experience and external publications and patents, including development of sterile products for IV, IM, and/or SC route of administration (liquid and lyophilized).
• Experience, desire, and a track record of effective mentorship of junior scientists towards timebound goals.
• Strong knowledge of QbD principles and experience applying the QbD tools to drug product development, and experience in designing appropriate DOE studies to inform on risks.
• Experience with process scale-up, definition of critical attributes, and technology transfer of early phase and/or late phase drug product manufacturing processes to GMP production facilities.
• Experience authoring regulatory filings, and demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC. Strong understanding of integration and partnering with Quality, Regulatory, Operations, Non-clinical, Clinical, and other functional areas.
• Demonstrated experience leading cross-functional teams and driving key capability evaluations and technology selection / builds.
• Excellent verbal and written communication skills, demonstrated initiative, strong interpersonal and collaboration skills, and a strong desire to learn and contribute.

Preferred Experience and Skills

• Experience with intermediate modalities (including oligonucleotides and peptides), non-conventional sterile dosage forms (including ocular and inhaled products), and/or alternate delivery technologies (e.g., high concentration, hydrogels, emulsions, suspensions, injectable depot).
• Experience influencing regulatory strategies and a track record of supporting global filings.
• Experience on a large capital project team, knowledgeable of the Sterile Standards and equipment design standards, and understanding of project / engineering work process and deliverables (e.g., equipment fabrication, FAT, SAT, qualification / validation).