Research Associate, Formulation Development

About the Role

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.

Key Responsibilities

• 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 drug inventory control and reconciliation.
• Responsible for designing, developing, and conducting appropriate characterization studies for novel dosage forms.
• Responsible for following existing and application new SOPs and equipment operating procedures.
• Preparation, review, and finalization of product development reports.
• 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 the significance of bio/clinical/In-vitro study results.
• Preparation and review of registration lot documents, technical reports, and submission-related documents in accordance with application FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)(2), NDA, and Para III and IV certified ANDA, while maintaining company safety standards.
• Responsible for large scale batch 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.

Interactions

• Should be able to interact with cross-functional stakeholders such as QC, QA, Regulatory, Marketing, Clinical, Purchasing, and Commercial departments for the successful development of new products.

Requirements & Tech Stack

• Inhalation and Nasal spray formulation development
• QBD approach
• Para IV ANDAs
• IRF
• Pre-formulation
• Formulation development
• Bio study review
• Clinical study review
• Clinical supply manufacturing
• Drug inventory control
• Characterization studies
• SOPs
• Product development reports
• Stability protocols
• Stability data
• Raw material specifications
• Finished product specifications
• In-vitro study results analysis
• Registration lot documents
• Technical reports
• FDA guidelines
• ICH guidelines
• CMC
• CTD sections
• IND
• 505(b)(2)
• NDA
• Para III ANDA
• Para IV ANDA
• Large scale batch execution
• Technology transfer documentation
• Drug device control documentation