*On site role in New York*
A leading global pharmaceutical company based in New York is looking for a Formulation Scientist to join their growing team. The company is dedicated to high-quality, branded, generic medicines. This individual will act as an individual contributor and be reporting to the Director of Research and Development.
Responsibilities
- Act as a subject Matter expert (SME) on pre-formulation and formulation, process development and technology transfer for sterile injectable/parental dosage forms
- Responsible for primary packaging development and optimization
- Develop robust-lab sacle, pilot scale, and commercial-scale manufacturing process based on Quality by Design Principles using design of experiments (DOE)
- Review and analyze relevant stability lab data
- Provide support to external collaborators (CDMOs, CROs), act as a single point technical contact
- Draft and/or participate in drafting relevant sections of regulatory fillings, 505(b)(1), 505(b)2 submissions
- Train peers and junior staff members on new techniques
Qualifications
- Ph.D. in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Pharmaceutical Chemistry, Analytical Chemistry, or related field with 2+ years of industry experience
- Masters Degree in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Pharmaceutical Chemistry, Analytical Chemistry, or related field with 4+ years of industry experience
- Experience with basic concepts of sterile injectable/parental products is a must
- Understanding of Industrial Pharmacy, physical pharmacy, and physical chemistry is a must
- Experience with process analytical technologies (PAT) is a plus
Physical Requirements
- Unassisted lifting up to 10 kg. may be required
- Able to wear personal protective equipment at all times, when required
