Biocon Hiring for MANUFACTURING SCIENCE & TECHNOLOGY (MSAT) (Biocon Biologics) at   Bangalore Full Time

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan.

Manufacturing tech transfer operations in both Microbial and Mammalian plants

Job Objectives: Directs the development, planning and implementation of product and process development of new products and technologies from pilot plant to manufacturing scale. Provides strategic direction, tactical oversight and technical expertise for all activities with respect to technology transfer and scale up.

Strategic

– Provide strategic direction, tactical oversight and technical expertise for all activities with respect to capacity expansion and qualification.

– Single point of contact for all regulatory discussions.

Operational

– Manufacturing support for Facility fit, technology transfer, scale up and qualification for new products.

– Anchor and be fully accountable for DS and DP validation campaigns.

– Support manufacturing group to troubleshoot and approve unplanned / planned process deviations.

People

Relationship Management: Able to build constructive and effective relationships with a broad and diverse group of business partners. Ability to influence at all levels, as well as a demonstrated ability to work effectively within a team and be assertive in driving successful management strategies

– Support commercial manufacturing operations at facilities to ensure industry standards for quality, regulatory compliance, customer service and cost are maintained.

– Implement metrics to rank performance and communicate the results verses expectations with management.

– Evaluate commercial processes and institute process optimization, debottlenecking and throughput increase initiatives where applicable.

– Direct product technology transfer projects to meet approved quality, timeline and budgetary initiatives.

– Support the Process Development Group and DS Manufacturing Group to facilitate development of robust commercial manufacturing processes.

– Troubleshooting of facility / equipment related deviations and propose CAPA with a clear action and qualification plan for long term resolution.

– Participate/ coordinate facility audits, as assigned.

– Write/review/execute and/or approve all process and equipment qualifications, validation protocols and reports with the QA team

– Write/review/execute and/or approve Facility and equipment related process deviations and investigations with the QA team.

– Represent Operations on the Change Control Committee.

– Best Practices – Improve processes and policies in support of organizational goals. Formulate and implement departmental and organizational policies and procedures to maximize output. Monitor adherence to rules, regulations and procedures.

– Communication – Monitor, manage and improve the efficiency of support services including Engineering, Warehouse, Purchase facility management etc. Facilitate coordination and communication between support functions.

– Represent departmental activities as needed, including project teams, task forces, audits and business or technical meeting with outside groups.

– Work closely with project team while construction of the facility is going on including providing technical inputs in finalizing equipment’s.

15 + years of experience in all aspects of process / product development. Experience with cGMP, process development/scale-up and qualification is preferred. Should have knowledge / experience in process characterization as per regulatory requirements. Should have work experience in end to end manufacturing process of both the microbial and mammalian expression system. Should have strong knowledge in cGMP, global regulatory requirements etc.