Job Description

Exciting Opportunity at Kemwell Biopharma!
We are urgently looking for Manager / Sr. Manager – Bioassay – Quality Control

Job role: Scientist
Department: Quality Control
Experience Level – 12 – 18 Years
Job Location – Bangalore

Requirements –
Experience: 12-18 years in Quality control and exposer to regulatory audit like US FDA, EMA, TGA, CDSCO, WHO etc.
Good communication, writing skills, and must have experience to handled team of 6-10 people
Experience field: Cell culture-based Bioassay for monoclonal antibody such as trastuzumab, bevacizumab, Rituximab and other bi-specific or tri-specific monoclonal antibody.
Job responsibilities:
1. Implements and ensures adherence to Kemwell Biopharma quality system. Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of products.
2. Responsible for managing all Quality functions and working with other departments to deliver high quality products on schedule. The QC Manager makes decisions over the shipment of products and accepts the responsibility for products being in compliance with all regulatory and company standards.
3. Reviews and resolves quality control problems/concerns with others including vendors, customers, and DS/DP manufacturing
4. Prepares reports and other documentation required or requested by regulatory agencies and customer audits to support the quality function.
5. Assumes quality role on bioassay method transfer and validations. Will be responsible for Method transfer/validation protocol and reports. To provide leadership and technical expertise to achieve quality control standards as per SOPs for all product at every stage of process.
6. Provide analytical support to commercial products as well as products in pre-clinical and clinical stage.
7. Lead QC bioassay team for all regulatory audits such as US FDA/EMA/NPRA/CIDSCO etc. and client audits.
8. Actively engages in overall project and ensures own work is aligned with overarching goals.
9. Overall responsible for maintaining the compliance of section.
10. Responsible for OOS investigations.
11. Works with cross-functional teams within the organization to solve/support both technical and process-related issues.
12. Responsible to plan resources required for Cell culture/Bioassay section.
13. Shares technical expertise with team members and serves as a mentor for them.
14. Should lead way for LIMS implementation and document digitalization process and lead the organization towards digital QC system.
15. Knowledge of handling cell culture-based bioassay for monoclonal antibodies (mAbs) such as ADCC, CDC assay. Experience in plate-based assays (ELISA) preferrable.
16. Should have experience in MCB/WCB release.

If you are passionate about cutting-edge biotechnology and want to be part of a dynamic team driving innovation, apply now!

Interested candidates can share their CVs at srrecruitment.hr@kemwellpharma.com