Formulation Development
5 days ago
Role & responsibilities
- Lead formulation strategy for new product development and lifecycle management.
- Drive end-to-end launch readiness: exhibit batches, scale-up, tech transfer, and validation.
- Collaborate with cross-functional teams (RA, QA, BD, SCM, PMO) to ensure launch timelines are met.
- Manage documentation for regulatory submissions (ANDA, CTD, etc.).
- Oversee equipment readiness, raw material planning, and pilot batch execution.
- Participate in project review meetings and provide technical updates to leadership.
- Identify risks and implement mitigation strategies during formulation and launch phases.
- Mentor and guide junior scientists and technical staff.
Preferred candidate profile
- M.Pharm / M.Sc in Pharmaceutics or related field.
- 10-15 years of experience in formulation development and commercial launch.
- Strong knowledge of cGMP, ICH guidelines, and regulatory expectations (USFDA, EU, ROW).
- Proven experience in handling oral solid dosage forms (OSD), injectables, or complex generics.
- Excellent project management, communication, and leadership skills.
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