Biocon - Assistant Manager - Biosimilars Downstream Manufacturing

Responsibilities:

- Scheduling, planning, executing, monitoring and control of shift based manufacturing operations.

- Responsible for the downstream operations for the purification of cell culture processes for the production of monoclonal antibodies.

- Preparation and review of cGMP documents like SOP, batch records, checklists, protocols and reports.

- Maintaining the equipment and facility in a state of compliance with effective calibration, preventive maintenance and validation programs.

- Organizing workflow by assigning responsibilities and preparing work schedules to meet the production targets.

- Managing and mentoring a small group of experienced employees for downstream operations.

- Analyzing and resolving equipment, process and operational problems in an effective and timely manner.

- Coordinating with cross functional teams for the smooth functioning of operations to achieve the departmental objectives.

- Facing internal and external audits, ensuring highest level of compliance for cGMP and EHS norms.

Education & Experience Required :

- Graduate/Post graduate in life sciences with 10+ years of experience.

- Experience in large scale purification of biologicals for commercial and clinical requirements.

- Good communication and interpersonal skills.

- Problem solving skills, highly motivated with a results driven approach.