About Kemwell Biopharma Pvt Ltd:
Kemwell is a biologics focused Contract Development and Manufacturing (CDMO) company providing services to global biopharmaceutical organizations. 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 facility consists of a cGMP drug substance manufacturing area with over 5000L bioreactor capacity, sterile fill and finish areas for cGMP drug product manufacturing and process development laboratories to support production of protein therapeutics such as monoclonal antibodies, bi-specific antibodies, fusion proteins, etc. Kemwell is capable of supporting novel, bio-better and biosimilar programs’ preclinical development, clinical development, cGMP clinical manufacturing and cGMP commercial manufacturing.
Kemwell, was established in 1980 and has had long term associations with pharma majors such as Bayer, GlaxoSmithKline, Merck KGaA, Novartis, Pfizer and others for small molecule contract mfg. and R&D. In 2016, Kemwell divested its small-molecule division to focus on biologics. Leveraging its vast and rich experience, Kemwell provides high quality service to enable its customers to be competitive and reach the market faster.
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About Kemwell Biopharma Pvt Ltd Jobs Vacancy:
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.
4. QC- Analytical: Dpty 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.
5. QC- Physicochemical:
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.