|Specific Duties and Responsibilities:|
Our growing R&D lab is looking for talented Senior Formulation Scientists to join our group.
- Lead formulation development of parenteral formulations in a product development environment using QbD principles.
- Lead activities with help of other scientists, chemists for various formulation development studies required for ANDA and NDA product development of Parenteral drug products - Liquid and lyophilized formulations.
- Plans, develops and implements scientifically well-designed experimental program with minimal supervision.
- Maintain experimental records, procedures to meet cGMP requirements.
- Participate in the review process for appropriate department SOPs, study protocols, and reports.
- Participate in the training of incoming laboratory staff.
- Participate as needed in departmental efforts directed toward equipment maintenance, calibration, and qualification.
- Coordinate technology Transfer to internal commercial site and CROs/CMOs
- Author formulation development activities for Chemistry, Manufacturing and Control (CMC) document for Regulatory submission.
- Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule.
- Provide crucial support to other team members in the conduct of their studies.
Education Minimum / Recommended:
- Ph.D. in Pharmaceutics or other related field with 3+ years’ experience
- MS in Pharmaceutics or other related field with 5+ years’ experience
- BS in Pharmaceutics or other related field with 7+ years’ experience
Work Experience Required:
- Minimum 3 to 7+ years of experience is required.
- Experience in complex sterile injectable products including suspensions, emulsions, oncology products and drug device combination products containing either small molecule or Peptide APIs is a plus.