Plant Operations Manager/Plant Manager

Responsible for Smooth Functioning of plant & to meet monthly production with optimum utilization of resources of Plant & also responsible for research & development of Immunology - Rapid + Biochemistry + Hematology + Mol Diagnostics and lateral flow test to ensure the addition of new products to fill the gap in portfolio for the business growth and team management. The incumbent will be responsible for adding new products as well as improvement of existing one as per requirement & Plans, Coordinates and Execute Manufacturing activities designed to ensure continuous production of products consistent with established standards.

Responsibilities

Responsible for smooth functioning of plant and meeting monthly production with optimum utilization of resources; Responsible for research and development of Immunology - Rapid + Biochemistry + Hematology + Mol Diagnostics and lateral flow test; Adding new products and improvement of existing ones; Coordinate and execute manufacturing activities to ensure continuous production consistent with established standards; Plant P&L and budgeting; Provide inputs towards plant strategy and create strategic roadmap for Dehradun plant; Manage relationship with regulatory bodies and internal customers; Ensure technical development of plant resources, systems and processes; Ensure Plant Quality compliance with organizational processes and regulatory/statutory requirements; Develop high performance work environment; Ensure Plant EHS Operations in compliance with Global guidelines; Driving ABS Culture in the Plant; Responsible for Plant Procurement and Inventory Controls; R&D team management and project assignment; Handling lifecycle of projects including design, execution, improvement; Project alignment as per business requirement; Project costing and R&D budget planning; Maintenance of company's Intellectual Property; Training on safety, scientific/technical, regulatory and compliance; Handling R&D projects for design, development, troubleshooting, documentation, cost analysis; Vendor identification, finalization, negotiation, sourcing; Reviewing potential of upcoming projects/technologies/products; Preparation and documentation as per ISO 13485; Maintain R&D data and technology methodologies; Technical and scientific support to R&D, production, PMT team; Monitoring in-house developed products; Review and approval of department procedures and protocols; Initiate and approve necessary change controls; Timely completion of investigations and action points for Incidents/CAPA and audit observations; Ensure adherence to records management policies; Conduct trainings timely; Maintain 5S in work area; Ensure safety requirements in place; Ensure cGMP and Good Documentation practices; Timely intimation of NC for investigation and NC closure

Requirements

Minimum 10-12 Yrs Experience in Invitro Diagnostics field; Minimum 5 Yrs of People Handling Experience; Expertise in developing in-vitro diagnostic kits such as ELISA, rapid card test, biochemistry, protein expression and purification; Scientific & technical knowledge in diagnostic/life science business for research and development of diagnostic products; Designing & prototyping various diagnostic products; Sound knowledge of ELISA, clinical chemistry, rapid techniques and hematology; Skilled in resource allocation to meet tactical demands and strategic business needs; Customer (internal and external) driven approach; Knowledge of investigation tools; Demonstrated knowledge and application of ISO 9001 & ISO 13485; Computer skills in MS Office, MS Project etc.; Ability to technically review documents from other areas for departmental impact; Time management; Team Leader; Problem-solving skills; Administrative skills; Effective written, verbal and listening communication skills; Honest and trustworthy; Respectful and flexible

Nice to have

Post Graduate in Biotechnology / BTech Biotech / PhD in Biotechnology or Microbiology; MBA in Operations Management

Benefits

Diverse, equitable and inclusive culture; Learning experiences to support career growth and success; Opportunities to contribute talents, learn new skills and grow career