Director/ Sr. Manager- Formulation Development – Innogenix Inc.
- Lead projects (Generic products) from formulation development to exhibit batch manufacturing to Validation Batches.
- Assist with pre-formulation and formulation development of Immediate/Delayed/Controlled release oral Solid pharmaceutical dosage forms (includes Tablets, Capsules and Powders for Solution/Suspension)
- Development of manufacturing processes at lab scale
- Technical transfer to manufacturing site including providing assistance during batch manufacture
- Assist in responding to CMC deficiencies from FDA
- Write technical reports for Submission and Validations.
- Hands on experience on R&D and production equipment’s related to Solid dose processing.
- Preparation of all documents related to Exhibit batches/ Validation and site transfer batches.
Qualification: MS in Pharmaceutics or Related field with at least 6-10 years of Solid Dosage forms development experience or BS in Pharmaceutics, Chemical Engineering or related field with more than 8-12 years of Solid Dosage form product development experience.
Skills:
Experience with other dosage forms such as Suspensions and Solutions is a plus. Experience in transfer of technical process information to manufacturing site. Excellent technical writing skills (experimental protocols, development reports, and technology transfer reports). Ability to work independently with minimal supervision
Job Type: Full-time
Pay: $125,000.00 - $140,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Supplemental pay types:
Experience:
- Generic product development: 8 years (Required)
- Project management: 3 years (Required)
- Business consulting: 1 year (Preferred)
Ability to Commute:
- Amityville, NY 11701 (Required)
Ability to Relocate:
- Amityville, NY 11701: Relocate before starting work (Required)
Work Location: In person