MSAT - Manufacturing Sciences & Technology
2 days ago
About Company:
Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.
Website:
Role: DP MSAT - Manufacturing Sciences & Technology / MS&T
Designation: Assistant / Deputy Manager
Job Description:
Primary responsibilities:
- Author & Review for Tech Transfer documents preparation for CMOs.
- Development & PPQs batches execution support to CMOs Mfg. & Tech transfer team.
- Author Product impact assessment for process and equipment-related deviations and out of specification investigations at CMOs site & L1.
- Technical support for Root Cause Investigations for Process Deviations at CMOs site during development and PPQs & commercial support (If require).
- Author Root Cause Investigations for OOS and OOTs for product attributes for in process, release, and stability.
- Review of new processes and new products and the associated Technology transfer.
- Review Hold Time Validation protocol and report.
- Authoring/Review of Continued Process Verification (CPV) protocol. Analysis of batch data and trends and summary of CPV report.
- Authoring/review Protocol and technical reports for justification for process parameters, designation of critical where relevant, output attributes and ranges.
- Authoring/review protocol and technical reports to support process changes, modifications, improvements and scale up to support implementation at manufacturing scale. Authoring study protocols and reports for any trials to support the same.
- Contribute during regulatory inspections and audits.
Secondary responsibilities (Wherever applicable):
- Manufacturing floor technical support in support of Clinical and Commercial campaigns
- Monitoring and analysis of manufacturing data as necessary to provide support for process deviations, investigations, process transfers, or equipment troubleshooting.
- Data analysis and coordination of the execution of experiments (run at Research and Development laboratories) aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment for commercial products. (as needed)
- Review of standard operating procedures and batch manufacturing records for changes made related to equipment or process for validated commercial products.
- Training of manufacturing personnel for manufacturing process.
Qualifications:
Masters or Bachelor's in science with Pharma or Biosimilars experience preferred
Equal Opportunity Statement:
Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.
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