Kemwell Biopharma Pvt. Ltd is a biologics focused Contract Development and Manufacturing (CDMO) company providing services to global biopharmaceutical organisations. Kemwell’s facilities, located in Bangalore, India, are designed with technological support from a leading German biopharma company. Kemwell provides customers with cost-effective access to state-of-the-art technology for all mammalian cell culture based products’ development and cGMP manufacturing of both drug substance and drug product. Kemwell is capable of supporting novel, bio-better and biosimilar programs’ preclinical development, clinical development, cGMP clinical manufacturing and cGMP commercial manufacturing.
“We are Hiring”
Kemwell Biopharma Pvt. Ltd. Is hiring for below functions
1. QC- Bioassay : Executive
- Candidates preferably with experience of 3-5 years in handling of cell lines and primary cells including all routine tissue culture practices, cell-based assays, ELISA, reporter cell line-based assays, Immunophenotyping.
2. DS- Quality Assurance: Executive/Sr. Executive
- Candidates preferably with experience of 3-6 years in handling mAbs DS manufacturing process and change over procedure with Review of MFR, BMR, SOPs, protocols, Reports & QMS elements
3. QC- Microbiology: Executive/Sr. Executive
- Candidates preferably with experience of 5-7 years in handling Media preparation, GPT and non-routine protocol based studies/validation activities with required and defined level of compliance to defined procedures and cGMP requirements & to perform /review of compressed air analysis, viable and non-viable Environmental monitoring of clean rooms and trending of data.
- Preparation of SOPs, STPs, protocols and reports related to Microbiology section
3. QC- Analytical: Dy. Manager
- Candidates preferably with experience of 10-12 years in handling coordination activities with QA, Engineering, Manufacturing department, PD and other section in QC for sampling, analysis, reporting of results and related activities in timely manner &
- To participate in the execution of qualification (URS, IQ, OQ, PQ and RQ), execution and preparation of report for equipment related to Biochemical sections.
- To prepare method validation protocol and ensure timely execution and compilation and report preparation. To involve in troubleshooting the problems in the analysis of method validation.
- To ensure overall GMP, GDP and GLP compliance in Biochemical section.
4. QC- Physico chemical
- Candidates preferably with experience of 8-10 years in supervising all analysis, sample distribution and outsource activities under the purview of Physico-chemical laboratory, as per approved documents and EHS recommendations & to review DRS and periodic verification of all reagents/solutions in Physico chemical section.
- Preparation and Review of SOP, Specifications and STP for Physico-chemical section. Draft protocols, execute (wherever applicable), compile results and prepare reports for general study, method transfer, method and equipment qualification & method validation activities pertaining to Physico -chemical section.
Qualification: M.Sc(Microbiology/Biotechnology/Biochemistry)
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