Assistant Manager Manager– Manufacturing (Biologics – Mammalian Microbial)
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Job Location:
Monthly Salary:
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
About Client
Leading Biopharma client catering to global markets.
Position Overview
We are seeking highly motivated professionals to join our Biologics Manufacturing team focusing on the production of mammalian cell–derived monoclonal antibodies (mAbs). The role involves hands-on execution monitoring and optimization of upstream (cell culture) and downstream (purification) processes in compliance with GMP standards.
Key Responsibilities
Upstream Manufacturing (Cell Culture)
- Operate and monitor bioreactors (seed train to production scale) for mammalian and Microbial cell culture.
- Prepare and sterilize media feeds and supplements.
- Execute inoculation expansion and harvest operations.
- Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
- Troubleshoot cell growth viability and productivity issues.
- Maintain batch records and ensure compliance with SOPs and GMP guidelines.
Downstream Manufacturing (Purification)
- Perform harvest clarification (centrifugation depth filtration).
- Execute chromatography steps (Protein A ion exchange hydrophobic interaction).
- Conduct ultrafiltration/diafiltration (UF/DF) for buffer exchange and concentration.
- Operate automated purification skids and filtration systems.
- Monitor yield purity and process consistency.
- Support viral clearance and impurity removal validation activities.
Cross-Functional Responsibilities
- Collaborate with Process Development Quality Assurance and Quality Control teams.
- Participate in technology transfer and scale-up activities.
- Support deviation investigations CAPAs and continuous improvement initiatives.
- Ensure equipment calibration cleaning and preventive maintenance.
- Contribute to drafting and reviewing SOPs batch records and validation protocols.
Qualifications
- Bachelor’s/Master’s degree in Biotechnology Biochemistry Chemical Engineering or related field.
- 8–10 years of experience in biologics manufacturing (mAbs preferred).
- Hands-on experience with mammalian cell culture and purification technologies.
- Familiarity with GMP regulatory guidelines (FDA EMA ICH).
- Strong analytical troubleshooting and documentation skills.
- Ability to work in a fast-paced team-oriented environment.
Desired Competencies
- Knowledge of single-use technologies (SUT) for bioreactors and purification.
- Experience with process automation and SCADA systems.
- Understanding of viral safety and regulatory expectations for biologics.
- Strong communication and organizational skills.
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
