Responsible for Injectable dosage form manufacturing and packaging for Liquid Vials, Lyophilized vials and Prefilled Syringes for small molecules and large molecules
Job Summary
Responsible for Injectable dosage form manufacturing and packaging for Liquid Vials, Lyophilized vials and Prefilled Syringes for small molecules and large molecules.
Responsible for production & packaging management for Injectables for pilot and commercial plant, ensuring cost-effective operations and facility planning.
Responsible for implementation of cGMP requirements to meet compliance w.r.t. USFDA, EU, MHRA standards and lead client visits/audits.
Matching Summary
Responsible for Injectable dosage form manufacturing and packaging for Liquid Vials, Lyophilized vials and Prefilled Syringes for small molecules and large molecules.
Skills & Requirements
Must-have
Injectable manufacturing and packaging
Liquid Vials and Lyophilized vials
Prefilled Syringes manufacturing
Small and large molecules
cGMP requirements implementation
Isolator based filling line
Nice-to-have
Thought leader experience
Corporate culture promotion
Operational discipline
Proactive planning
Problem-solving skills
Key Requirements
B. Pharm/M. Pharm/MSc. education
Experience handling clinical supply, Exhibit and commercial batches
Media fill and Trouble shooting experience
21 CFR compliance
EU annex 1
Environmental monitoring program for Sterile manufacturing