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

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