In the development of novel product formulations, technical transfer, and support of corporate strategy, this Sr. Scientist, Formulations role provides technical leadership and project management. This senior technical position is responsible for all elements of product development and leads the team. This position will be responsible for technical, logistical, and financial project management, as well as contributing to the company's intellectual property growth. As a Product Creator, this job will serve as a product SME throughout the lifecycle of assigned products. This position will require collaboration with all technical and quality divisions, as well as marketing (product design and label claim creation), and operations.
Responsibilities:
- Design, draft, and implement development processes and reports; attend project meetings to report on progress.
- Develop and manage project plans for technical services work, including schedules, budgets, and contractual bids.
- Justifications and design choices for raw materials and major packaging materials should be written. Provide technical skills in defining user needs in collaboration with the procurement department and supporting vendors.
- Design, write, and implement engineering research and clinical supplies development protocols and reports.
- In support of a Chemistry and Manufacturing Controls (CMC) filing with the FDA, manages many development projects at various levels from proof of concept to stability and validation.
- To properly design experiments and protocols, you must be able to articulate the goal and objective of the investigations.
- Must be able to assess and analyze raw data as well as comprehend the outcomes.
Experience Required:
- 3+ years' work related experience required with PhD, prefer 7+ years' experience with BS or MS degree required; experience in pharmaceutical formulations to include expertise in bioequivalence studies, PK/PD modeling, and/or process design. 3+ years in project management or expense budgeting required.
- Must have a pharmaceutical, cGMP, background with an FDA regulated laboratory. Familiar with USP and ICH guidelines as well as fundamental principals of project management. Must have strong technical writing and documentation skills.
