Company overview:
Hetero Drugs is an Indian pharmaceutical company and the world's largest producer of anti-retroviral drugs. Hetero's business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
Job Title: Scientist II - Formulation Research and Development (Injectables)
Department: Formulation R&D (FR&D)
Location: Jeedimetla, Hyderabad
Experience: 7-10 Years
Reports To: Group Leader / Manager - FR&D
Job Summary:
We are seeking a highly experienced and motivated Scientist II to join our Formulation R&D team focused on the development of sterile injectable formulations including aqueous, non-aqueous, lyophilized, and peptide-based oncology products. This role is critical to advancing product development for regulated markets (US, Europe, and ROW) and involves comprehensive formulation design, process optimization, regulatory documentation, and interdepartmental coordination.
Key Responsibilities:
- Independently lead the development of sterile injectable products: aqueous, non-aqueous, lyophilized, and peptide-based formulations.
- Conduct formulation studies, process optimization, and scale-up activities to develop robust and reproducible manufacturing processes.
- Perform material compatibility studies including container-closure components (filters, tubing, rubber stoppers).
- Prepare critical product development documents including:
- Test/Manufacturing license applications
- Master Formula Cards (MFCs)
- Exhibit batch procurement packages
Job Description - Scientist II (FR&D)
- Stability study protocols and notes
- Process evaluation protocols
- Product development reports
- Conduct and support filter validation and terminal sterilization studies.
- Prepare technology transfer documentation for successful transfer to commercial manufacturing.
- Collaborate with Analytical Development, Regulatory Affairs, and Tech Transfer teams throughout the development lifecycle.
- Contribute to regulatory submissions (ANDA, EU dossiers) and actively participate in responding to regulatory queries.
- Ensure compliance with cGMP and ICH guidelines, and support audits and inspections as required.
Required Qualifications:
- M.Pharm / M.S. in Pharmaceutics, Pharmaceutical Technology, or related field.
- 7-10 years of industry experience in formulation development of sterile injectables.
- Hands-on expertise in oncology injectables, peptide formulations, and lyophilization process development.
- Strong working knowledge of USFDA, EMA, and ROW regulatory requirements.
- Proven experience in technology transfer, scale-up, and regulatory documentation.
- Excellent communication, problem-solving, and cross-functional collaboration skills.
