Title: R&D Senior Scientist - Leading Global Pharmaceutical Company
Location: New York Area
Base Salary: 80,000 - 100,000
I am partnered with a a leading global pharmaceutical generics company. The 'R&D Senior Scientist, Sterile Injectable/Parenteral/Solid Oral Formulations' position is an individual contributor role and reporting to the Director of Research & Development (R&D). My client is looking to bring on strong scientists that want to challenge their scientific skillset through exposure to several stages of development as well as numerous modalities.
Responsibilities:
- Operate as the subject matter expert (SME) on pre-formulation and formulation, process development and technology transfer to sterile injectable / parenteral formulations.
- Lead formulation and process development, product characterization, process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products.
- Analyze data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction.
- Draft relevant sections of dossiers towards 505(b)(1), 505(b)(2) or 505(j) submissions.
Qualifications:
- PHD in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
- Experience working with multiple dosage forms including injectables, solid oral dosage, and parenteral products
- Experience with manufacturing scale equipment
- In depth understanding of pre-formulation and formulation studies
