Research Associate – Formulation Development at Lupin, Pune District, Maharashtra, India
Lupin is hiring a Research Associate – Formulation Development in Pune District, Maharashtra, India, for development of inhalation and nasal spray complex generic formulations and related regulatory and technology transfer work.
Job Details
Company: Lupin
Designation: Research Associate – Formulation Development
Location: Pune District, Maharashtra, India
Key Responsibilities
- Responsible for development of Inhalation and Nasal spray non-infringing complex generic formulations using QBD approach and first to file Para IV ANDAs for advance (US, EU) and other regulated markets including IRF.
- Responsible for pre-formulation and formulation development experiments for new drug products.
- Responsible for reviewing the bio study and clinical study designs and protocols, support clinical supply manufacturing and labelling activities along with the drug inventory control and reconciliation.
- Responsible for designing, development and conducting appropriate characterization studies for the novel dosage forms.
- Responsible for following existing and application new SOP’s and equipment operating procedures.
- Preparation, review and finalization of product development report.
- Responsible for preparing stability protocols and compiling stability data for review. Set specifications for raw material and finished products for manufacturing scale up, exhibit, clinical or bio study batches of drug product.
- Responsible for analyzing and interpreting significance of bio/clinical/In-vitro study results. Preparation and review of registration lot documents, technical reports and submission related documents in accordance with the application FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)(2), NDA and Para III and IV certified ANDA with maintaining safety standards of the company.
- Should be able to interact with cross function stake holders such as QC, QA, Regulatory, Marketing, Clinical, Purchasing and Commercial departments for the successful development of new products.
- Responsible for large scale batches execution at site along with preparation, review and ensuring completion of technology transfer related documentation of drug product. To review and ensure drug device control documentation as per guidelines.