Biocon - Operational Excellence

About Biocon :

Biocon Limited is India's premier biopharma enterprise focused on innovation to deliver affordable healthcare solutions to patients, partners and healthcare systems across the globe. Established in 1978 by Ms Kiran Mazumdar-Shaw, Biocon is committed to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune diseases to provide access to affordable treatment to patients across the global.

Biocon's key innovations include world's first Pichia based recombinant human Insulin, INSUGEN, insulin analogue Glargine, BASALOG and India's first indigenously produced monoclonal antibody BioMAb-EGFR, for head & neck cancer. INSUPen is a next generation affordable insulin delivery device introduced in India.

With a risk balanced business model comprising small molecules, novel molecules, biosimilars, branded formulations and research services. Biocon has fast evolved into an emerging global enterprise serving its partners and customers in over 80 countries. The Consolidated revenue for FY 12 stands at Rs 21480 million( US$ 445 mn)

Biocon, is among the top 20 global biotechnology companies and is the only Asian company in Top 25. Biocon Group employs over 6200 people including over 1700 high quality scientists at Syngene and Clinigene, the largest scientific talent pool at one site in India. Biocon is the 7th largest Biotech employer in the world.

Role :

- To lead the process engineering function and build the organization with people and work processes.

- Accountable for being the process equipment expert, supporting tech transfers and owing up the process scale equipment performance post transfer.

- Interact with R&D, Manufacturing and Regulatory leadership in maintaining manufacturing processes under validation cycle lead and support continuous improvement supports.

- Interact with manufacturing teams for discrepancy resolutions and CAPA accountability, where applicable. Author various protocols and conduct/facilitate evaluations and studies, especially cleaning validations.

Education: BE / M.Tech or equivalent.

Technical Skills:

- Equipment expertise, engineering background, process design expertise is critical.

- Appreciation of cGMP systems, large scale manufacturing, regulatory expectations in Biotechnology highly recommended.

- Proven CMC capability in academic and/or Biotech industry (India/Abroad) is highly recommended.

- Experience/knowledge in Insulin(s), preparative HPLC systems, protein crystallization and lyophilization is recommended.

- Fermentation and protein purification knowledge and significant stint hands-on is desirable.

Behavioral/Management/other skills:

- Learning and performance orientation skills are critical. Strategic team building and stakeholder relationships are highly recommended.