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Principal Scientist - Mixed Modalities, Sterile Product Development
Merck KGaA Darmstadt Germany - Rahway, NJ
posted 2 months ago
About the position
The Principal Scientist (R5) position within the Mixed Modalities team at Sterile Product Development focuses on the design and development of parenteral drug products, including injections, implants, inhaled, and ocular dosage forms. The role requires collaboration in a multidisciplinary team environment to ensure robust product composition, scalable processes, and successful regulatory filings, ultimately translating preclinical candidates into viable non-oral drug products.
Responsibilities
- Design and develop sterile products across injectable, implantable, ophthalmic, and inhaled dosage forms.
- Provide strategic and technical leadership on program development teams, interfacing with key stakeholders.
- Support early and late-stage development candidates, ensuring robust drug product composition and scalable processes.
- Collaborate with stakeholders across the organization to drive capability evaluations and champion strategic objectives.
- Maintain a strong network internally and externally, building collaborations across departments and with key stakeholders.
- Mentor and supervise a small group of scientists to develop capabilities.
Requirements
- Ph.D. with 8+ years industry experience, M.S. with 10+ years, or B.S. with 14+ years in relevant fields.
- Deep drug product development expertise with exposure to all stages of development and cGMP industrial background.
- Demonstrated scientific leadership and a strong track record in small molecule parenteral formulation and process development.
- Experience in developing sterile products for IV, IM, and/or SC routes of administration.
- Experience with complex drug delivery systems including long-acting injectables and particle-based systems.
- Strong knowledge of QbD principles and experience applying QbD tools to drug product development.
- Experience with process scale-up and technology transfer to GMP production facilities.
- Experience authoring regulatory filings and knowledge of FDA, ICH, and other regulatory requirements.
Nice-to-haves
- Experience with intermediate modalities such as oligonucleotides and peptides.
- Experience with non-conventional sterile dosage forms and alternate delivery technologies.
- Experience influencing regulatory strategies and supporting global filings.
- Experience on large capital project teams and knowledge of Sterile Standards and equipment design standards.
Benefits
- Bonus eligibility
- Long term incentive if applicable
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Sick days
