Executive, Formulation & Development Injectable

• Understanding of product development related activities of all injectable dosage forms for regulated market (General injectable and Onco products)
• Understanding of ANDA and 505b2 product filing.
• Exposure or knowledge to wide range of dosage form (liquid solution, lyophilized, suspension, emulsion etc.)
• Understanding of Drug device combination products and regulatory expectations.
• Exposure or Knowledge to equipment like high shear homogenizer, high pressure homogenizer, lyophilizer, microfluidizer, nano mill etc.
• Experienced in preparation and review of product development report, MFR, stability protocol, other study protocols, SOP etc.
• Basic understanding of implementation of QbD principles for formulation development (QTTP, CQA, CPP, CMA, Risk assessment and Control strategy etc.)
• Exposure or knowledge of various QMS documents like change control, Incidence, planned deviation, unplanned deviation etc.
• Basic understanding of API specification, DMF, Excipients specification, In-process specification, Finished product & Shelf-life specification of injectable products.
• Basic understanding of preparation and review of necessary documents required for ANDA submission and approval of products.

Sill and its level

Formulation Development - solution based injectables | Advanced

Scale-Up and Process Optimization | Intermediate
Regulatory Affairs and Compliance | Grow Material Science and Excipients Selection | Intermediate Cross functional Coordination | Intermediate CoA & Analytical Data Review | Advanced Investigation & CAPA Management | Intermediate Stability Testing | Intermediate Protocol Development and Documentation |Intermediate Cross-functional Collaboration |Intermediate Technical Troubleshooting | Grow

M Pharm