Job Description

🚨 We Are Hiring | Team Lead – Biologics Upstream Production 🚨
Kwality Pharma Ltd. is looking for a skilled professional to join our growing team.
📍 Location: Amritsar, Punjab
💼 Industry: Pharmaceuticals
Exp- 7year +
Salary-10 LPA

Key Responsibilities:
Team Leadership & GMP Execution: Directly supervise a team of USP Specialists. Schedule, train, and ensure flawless execution of all USP operations in a cGMP environment, emphasizing aseptic technique and compliance.
Bioreactor Process Mastery:
o   Oversee the entire seed train expansion in from flask level to glass bioreactors (5L – 15L) and inoculation of production-scale bioreactors.
o   Serve as the subject matter expert (SME) for the operation and control of large-scale stainless steel (SS) bioreactors (50L – 500L), including CIP (Clean-in-Place) and SIP (Steam-in-Place) cycles.
o   Master the control loops for critical process parameters (CPPs): pH (via CO₂/sparge), dissolved oxygen (pO₂ via gas blending), temperature, agitation, and back-pressure.
o   Execute and optimize fed-batch processes, including feed addition strategies and sample scheduling.
Process Monitoring & Advanced Troubleshooting:
o   Utilize real-time data trends (via SCADA, etc.) to monitor cell growth, metabolism and process performance, making proactive adjustments.
o   Lead complex troubleshooting efforts for process anomalies (e.g., cell viability drops, off-gas analysis shifts, contamination events, pH Fluctuations) and author thorough deviation investigations and CAPAs.
Technology Transfer & Scale-Up: Provide critical hands-on support for technology transfer and process validation, applying scale-up principles (e.g., constant P/V, kLa) from pilot to commercial scale.
Harvest & Clarification: Oversee the harvest process, including cell separation via centrifugation or clarification using depth filtration systems.
Must-Have Qualifications:
7+ years of hands-on, technical USP experience in a cGMP environment.
Must have proven experience operating and troubleshooting both glass/applied and large-scale stainless steel bioreactors.
Deep understanding of mammalian cell metabolism, cell culture media, and the impact of process parameters on critical quality attributes (CQAs).

📧 Interested candidates can share their CV at career@kwalitypharma.com

or WhatsApp CV – 9837454653