Biocon - Leadership Role - Injectables/Fill Finish Manufacturing

Leadership Role in -Injectables / Fill Finish Manufacturing

Job Purpose :

This is a Leadership Role in the Fill Finish Manufacturing Function of Insulin Business, aimed at leading the FFM Team to deliver the objective of Production Function.

Key Responsibilities :

- Develop the manufacturing team and supervise manufacturing activities as per the plans.

- Strategize production activity for the plant in co-ordination with Business, Supply Chain & Finance.

- Lead the packing team for packing of products day to day basis based on planning.

- Expert knowledge of the regulatory requirements like USFDA, MHRA, ANVISA and MCC etc. Should have been part of similar audits in the past.

- Lead & front end audits related to the plant in participation with quality.

- Review and approve production related documentation (the SOPs, Batch Records etc).

- Identify opportunities for continuous improvement in plant operations and implement them through management team, demonstrated ability to optimize costs, resource management skills.

- Provide regular reports and inputs to Senior Management.

- Hands-on experience in operation of Filling machine, Lyophilizes, Autoclaves, Particle counter,Intigrity apparatus,Filteration techniques, Different type of filters, clean equipment, Mobile tanks, Sterilization of equipments,CIP, SIP operation etc

- Should have in-depth knowledge in Current Good Manufacturing Practices. (CGMP)

- Experience in technology transfer & scale-up operations.

- Knowledge of new product development programs.

Educational Qualification :

- Graduate or Post Graduate from Premier Institute like ( NIT/REC, IIT,IIM,UDCT or equivalent )

Work Experience :

- No. of years : 15 Plus years

- Area of work : Fill Finish Manufacturing ( Injectables,Vials,PFS,SVP)

Technical/Functional Skills :

- Hands-on experience in operation of Filling machine, Lyophilizes, Autoclaves, Particle counter,Intigrity apparatus,Filtration techniques, Different type of filters, clean equipment's, Mobile tanks, Sterilization of equipment's,CIP, SIP operation etc

- Should have in-depth knowledge in Current Good Manufacturing Practices. (cGMP)

- Knowledge of new product development programs.

- Should have good communication skills.

- Resource management skills

- Demonstrated ability to optimize costs.

- Ability to identify opportunities for process improvement.

Behavioral/Managerial skills :

- High on initiative

- Ability to interact with cross functional departments.

- Ability to manage & motivate production teams.

- Conflict management (intra & inter- department)

- Planning & delivery skills - good prioritizing skills.

- Risk management.

- Talent management & development skills.