Are you a seasoned quality control professional passionate about biotechnology? Kemwell Biopharma, a leader in biopharmaceutical innovation, is hiring a Manager/Sr. Manager – Bioassay Quality Control to join our dynamic team in Bangalore. This role offers a chance to drive excellence in bioassay development for monoclonal antibodies like trastuzumab, bevacizumab, and rituximab, ensuring compliance with global regulatory standards. If you’re ready to lead a high-performing team and contribute to cutting-edge biopharma solutions, this is your opportunity!
Job Responsibilities
As a Manager/Sr. Manager in Bioassay Quality Control, you will:
- Implement Quality Systems: Develop and enforce Kemwell Biopharma’s quality standards, policies, and procedures for product production.
- Oversee Quality Functions: Collaborate with cross-functional teams to ensure high-quality product delivery on schedule, meeting regulatory and company standards.
- Resolve Quality Issues: Address quality control concerns with vendors, customers, and manufacturing teams for drug substances (DS) and drug products (DP).
- Prepare Regulatory Documentation: Create reports and documentation for regulatory agencies (US FDA, EMA, TGA, CDSCO, WHO) and customer audits.
- Lead Bioassay Method Transfer: Manage method transfer/validation protocols and reports, ensuring compliance with SOPs.
- Provide Analytical Support: Support commercial, pre-clinical, and clinical-stage products with analytical expertise.
- Lead Audits: Guide the QC bioassay team through regulatory and client audits (US FDA, EMA, NPRA, CDSCO).
- Drive Compliance: Maintain section compliance and lead out-of-specification (OOS) investigations.
- Resource Planning: Plan resources for the cell culture/bioassay section to meet project demands.
- Mentor Teams: Share technical expertise and mentor team members to foster growth.
- Digital Transformation: Lead LIMS implementation and document digitalization for a modern QC system.
- Handle Specialized Assays: Oversee cell culture-based bioassays (ADCC, CDC, ELISA) and MCB/WCB release for monoclonal antibodies.
Qualifications
To excel in this role, you should have:
- Experience: 12-18 years in quality control, with exposure to regulatory audits (US FDA, EMA, TGA, CDSCO, WHO).
- Technical Expertise: Proficiency in cell culture-based bioassays for monoclonal antibodies (e.g., trastuzumab, bevacizumab, rituximab) and plate-based assays (ELISA).
- Leadership Skills: Proven experience managing teams of 6-10 people.
- Communication: Strong written and verbal communication skills.
- Digital QC Knowledge: Experience with LIMS implementation and document digitalization is a plus.
- Education: Advanced degree in biotechnology, biochemistry, or related fields (preferred).
Benefits
Joining Kemwell Biopharma offers:
- Competitive Salary: INR 15,00,000–25,00,000 per year, based on experience.
- Career Growth: Opportunities to lead innovative projects in biopharma.
- Dynamic Work Environment: Collaborate with a passionate, cutting-edge team.
- Professional Development: Mentorship and training to enhance your expertise.
- Impactful Work: Contribute to life-changing biopharmaceutical solutions.
How to Apply
Ready to make a difference in biotechnology? Send your CV to srrecruitment.hr@kemwellpharma.com with the subject line “Manager/Sr. Manager – Bioassay Quality Control Application.” Applications are reviewed on a rolling basis, so apply by November 10, 2025, for priority consideration.
FAQs
Q: What specific skills are required for this role?
A: Candidates need 12-18 years of quality control experience, expertise in cell culture-based bioassays (ADCC, CDC, ELISA), and familiarity with regulatory audits (US FDA, EMA, etc.). Leadership and communication skills are essential.
Q: What is the deadline to apply for this position?
A: The application deadline is November 10, 2025, but early applications are encouraged for priority review.
