Serve as a lead scientist/engineer overseeing technical activities for a product or family of products in the oral dosage form space. Assume technical ownership of a given product(s) across the various stages of development and commercialization in coordination with other functional areas. Maintains product knowledge and serves as product focused subject matter expert.
- Capable of serving as the technical product/process expert of solid dosage form products, representing S&T across multiple functions.
- Contribute to the generation of new scientific proposals and lead those efforts. Maintain awareness of scientific or regulatory advances or competitive threats and implement new strategies as needed.
- Author, review, and/or approve technical reports and/or regulatory submission documents.
- Make significant contributions to the project team, including lab-based activities.
- Maintain a high level of productivity in the lab requiring only minimal direction from or interaction with supervisor.
- Ensure timely and robust technical transfers.
- Seize opportunities to pursue project relevant leads that are in line with the group’s strategy.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.
- Direct mentorship of others is possible.
- Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and 1+ years industrial experience is necessary.
- Experience in unit operations such as granulation, milling, compression, coating and/or extrusion processes for oral dosage form formulations including Amorphous Solid Dispersions and modified release products. Possess thorough theoretical and practical understanding of own scientific discipline.
- Effective writer and communicator of research or other regulatory materials.
- Experience in Amorphous Solid Dispersion, milling, compression and/or extrusion processes preferred.
- Experience leading complex technical projects that cross functional areas, including tech transfers for similar projects.
Significant Work Activities: N/A
Travel: Yes, 15 % of the Time
Job Type: Experienced