Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma in Bangalore. Apply by November 10, 2025 via email.
Kemwell Biopharma – Pioneering Biopharmaceutical Excellence
Kemwell Biopharma, a globally recognized leader in biopharmaceutical innovation, is inviting experienced professionals to join its team as Manager/Sr. Manager – Bioassay Quality Control in Bangalore, India. This is an outstanding opportunity for senior-level quality control experts who are passionate about biotechnology, biologics, and monoclonal antibody testing. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
As a company known for its commitment to quality, innovation, and global regulatory excellence, Kemwell Biopharma offers a work environment that fosters leadership, collaboration, and growth. This role will give you the opportunity to lead advanced bioassay operations, ensure regulatory compliance, and contribute to cutting-edge biopharmaceutical manufacturing. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
If you have strong experience in cell culture-based bioassays, regulatory audits, and quality systems, and are ready to lead a high-performing QC team, this position is a perfect fit. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
About Kemwell Biopharma
Kemwell Biopharma Pvt. Ltd. is one of India’s leading biopharmaceutical contract development and manufacturing organizations (CDMO), specializing in biologics and biosimilars. Headquartered in Bangalore, the company partners with global biopharma companies to deliver end-to-end solutions — from cell line development and process optimization to commercial manufacturing. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
With a strong focus on quality, compliance, and technological excellence, Kemwell Biopharma has successfully developed products for multiple international markets under strict regulatory frameworks, including US FDA, EMA, TGA, WHO, and CDSCO.
Its cutting-edge facilities, global collaborations, and emphasis on innovation make it one of the most respected names in the biopharmaceutical manufacturing ecosystem. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
Job Overview
Job Title: Manager/Sr. Manager – Bioassay Quality Control
Company: Kemwell Biopharma Pvt. Ltd.
Location: Bangalore, Karnataka
Education: Any Life Science Degree (Advanced degree in Biotechnology, Biochemistry, or related field preferred)
Experience Required: 12–18 years in Quality Control (Biopharma)
Department: Quality Control (Bioassay)
Type of Job: Full-Time, Permanent
Application Mode: Email Application
Application Email: srrecruitment.hr@kemwellpharma.com
Application Deadline: November 10, 2025
Salary Range: ₹15,00,000 – ₹25,00,000 per annum (based on experience)
Verified Job: Yes
Role Overview
The Manager/Sr. Manager – Bioassay Quality Control will oversee quality control processes for monoclonal antibody (mAb) bioassays, including trastuzumab, bevacizumab, and rituximab. The role involves leadership in bioassay method development, validation, regulatory compliance, and team mentoring.
You will work closely with cross-functional teams, including manufacturing, R&D, QA, and regulatory affairs, to maintain the highest quality standards in biopharmaceutical production. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
This position is ideal for a highly experienced professional who thrives in a dynamic, innovation-driven environment and is motivated by challenges in biologics quality control.
Key Responsibilities
1. Quality Systems Implementation
- Develop and implement quality systems, policies, and procedures in accordance with Kemwell Biopharma’s quality standards.
- Ensure adherence to global regulatory guidelines (US FDA, EMA, WHO, CDSCO, TGA).
2. Oversee Quality Control Operations
- Lead bioassay QC functions related to drug substances (DS) and drug products (DP).
- Collaborate with production, analytical development, and regulatory teams to maintain consistent product quality.
3. Bioassay Method Transfer and Validation
- Manage method transfer and validation activities for bioassays, ensuring alignment with approved protocols and SOPs.
- Oversee analytical testing for monoclonal antibodies and biosimilars.
4. Regulatory Documentation
- Prepare and review reports, validation documents, and audit-related materials for submission to global regulatory agencies such as US FDA, EMA, NPRA, WHO, and CDSCO.
- Support client audits with comprehensive technical documentation.
5. Analytical and Technical Support
- Provide analytical support to commercial, clinical, and pre-clinical product stages.
- Address out-of-specification (OOS) and out-of-trend (OOT) investigations effectively.
6. Leadership and Team Mentoring
- Manage a QC team of 6–10 professionals.
- Foster a culture of continuous learning and technical excellence within the department.
7. Resource and Project Management
- Plan and allocate resources for bioassay and cell culture sections to meet timelines and project goals.
- Coordinate cross-functional activities for efficient execution.
8. Digital Transformation and LIMS Implementation
- Lead initiatives for Laboratory Information Management System (LIMS) implementation.
- Digitize QC documentation for improved efficiency and traceability.
9. Specialized Bioassay Handling
- Oversee complex cell culture-based bioassays such as ADCC (Antibody-Dependent Cellular Cytotoxicity), CDC (Complement-Dependent Cytotoxicity), and ELISA (Enzyme-Linked Immunosorbent Assay).
- Manage Master Cell Bank (MCB) and Working Cell Bank (WCB) release activities.
10. Regulatory and Client Audit Leadership
- Represent the QC department during regulatory and client audits.
- Drive compliance initiatives and ensure that audit findings are addressed promptly and effectively.
- Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
Required Qualifications and Experience
To qualify for this position, you should meet the following criteria: Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
- Educational Background:
- Bachelor’s or Master’s degree in Biotechnology, Biochemistry, or a related life science discipline.
- Advanced degree preferred.
- Experience:
- 12–18 years of experience in Quality Control within a biopharmaceutical manufacturing environment.
- Proven track record of handling regulatory audits such as US FDA, EMA, TGA, WHO, and CDSCO.
- Technical Expertise:
- Strong understanding of cell culture-based bioassays for monoclonal antibodies (trastuzumab, bevacizumab, rituximab).
- Proficiency in plate-based assays such as ELISA.
- Leadership Skills:
- Demonstrated ability to lead and mentor teams of 6–10 people.
- Excellent project management and resource planning capabilities.
- Digital Proficiency:
- Experience in LIMS implementation, digital documentation systems, and data integrity practices.
- Communication Skills:
- Strong written and verbal communication abilities to coordinate across teams and present findings during audits.
Benefits of Working at Kemwell Biopharma
Kemwell Biopharma values its employees and offers a supportive, growth-oriented work culture. Joining the organization as Manager/Sr. Manager – Bioassay QC gives you access to numerous benefits, including: Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
- Competitive Compensation:
Attractive salary range of ₹15,00,000 to ₹25,00,000 per annum, depending on qualifications and experience. - Career Advancement:
Opportunity to lead high-impact biopharma projects and grow into senior leadership roles. - Dynamic Work Environment:
Work in a collaborative, technology-driven environment with a team of dedicated biopharma professionals. - Professional Growth:
Access to mentorship programs, training sessions, and exposure to international regulatory frameworks. - Meaningful Contribution:
Be part of a team that contributes to developing life-saving biopharmaceutical products impacting global healthcare.
How to Apply
Interested candidates who meet the eligibility criteria can apply through email. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
To Apply:
Send your updated CV to srrecruitment.hr@kemwellpharma.com
Subject Line:
“Manager/Sr. Manager – Bioassay Quality Control Application”
Application Deadline: November 10, 2025
Applications are reviewed on a rolling basis, so early submissions are encouraged for priority consideration.
Important Guidelines
- Ensure your resume highlights relevant experience in bioassay QC, regulatory compliance, and leadership.
- Mention details of major regulatory audits you have faced or led.
- Clearly list bioassay techniques and analytical tools you have mastered.
- Include your expected CTC and notice period in the application email.
- Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
Frequently Asked Questions (FAQs)
Q1. What skills are required for the Bioassay Quality Control role at Kemwell Biopharma?
Candidates should have 12–18 years of experience in quality control with hands-on expertise in cell culture-based bioassays (ADCC, CDC, ELISA) and experience in managing regulatory audits like US FDA, EMA, TGA, and WHO. Strong leadership and communication skills are essential. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
Q2. What is the salary offered for this position?
The salary range is between ₹15,00,000 and ₹25,00,000 per annum, depending on experience and qualifications.
Q3. What is the last date to apply?
The last date to apply is November 10, 2025, but early applications are given priority.
Q4. Is this a permanent job?
Yes, it is a full-time, permanent position at Kemwell Biopharma’s Bangalore facility.
Q5. Does Kemwell provide opportunities for professional development?
Yes, employees receive continuous training and exposure to advanced analytical and regulatory practices, ensuring career growth and technical mastery.
Conclusion
The Manager/Sr. Manager – Bioassay Quality Control role at Kemwell Biopharma is a prestigious opportunity for seasoned professionals looking to make an impact in the global biopharmaceutical industry. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
If you have strong technical expertise, leadership skills, and a passion for quality excellence, this is your chance to join a company that values innovation, integrity, and professional growth.
Take the next step in your career — apply now and be part of Kemwell Biopharma’s mission to deliver world-class biopharmaceutical solutions. Manager/Sr. Manager Bioassay Quality Control Job at Kemwell Biopharma
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