Job Title: Senior Manager – Upstream Process Development (mAbs)
Location: Ahmedabad, India
Employment Type: Full-Time
CTC Range: INR 15,00,000 – 25,00,000 per annum
Experience Required: 8–14 years
Job ID: 1264
Industry: Biopharma / Biotechnology / Clinical Research
Company Overview
Lambda Therapeutic Research Ltd. is a globally recognized, full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With state-of-the-art facilities and operations across Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda delivers comprehensive end-to-end clinical research and biopharmaceutical development services to innovator, biotech, and generic pharmaceutical companies worldwide.
Role Summary
Lambda Therapeutic Research is seeking an experienced Senior Manager – Upstream Process Development to lead monoclonal antibody (mAb) upstream process development activities. This on-site leadership role requires deep technical expertise in mammalian cell culture, process scale-up, technology transfer, and cGMP-compliant operations, along with proven people and project management capabilities.
Key Responsibilities
Provide technical leadership for upstream process development of monoclonal antibodies (mAbs) using mammalian cell culture systems.
Design, develop, and optimize upstream processes aligned with Quality by Design (QbD) principles and Design of Experiments (DoE).
Lead cell bank preparation, characterization, and aseptic cell culture operations.
Support consistency batches, engineering runs, clinical trial manufacturing campaigns, and drug substance generation for preclinical and clinical studies.
Perform detailed process characterization, capability studies, process improvement, and cleaning validation activities.
Analyze, collate, and present complex process data using DOE tools such as Minitab and JMP.
Oversee process scale-up, technology transfer, and collaboration with downstream purification teams.
Manage glass, single-use, and stainless-steel bioreactors, including ATF systems.
Evaluate and implement innovative upstream technologies to improve mAb yield and cost efficiency.
Ensure qualification, validation, maintenance, and compliance of laboratory, pilot-scale, and manufacturing equipment.
Author and review technical reports, upstream process documentation, and regulatory submission sections supporting IND-enabling studies.
Lead, mentor, and develop a high-performing technical team, fostering continuous learning and performance excellence.
Key Deliverables
Upstream process development, scale-up, and technology transfer
Team planning, leadership, and performance management
Technical documentation writing and review
Advanced data analysis and experimental design
Cross-functional collaboration and alignment
Allied Responsibilities
Ensure strict adherence to cGMP regulations and best laboratory practices
Maintain high standards of documentation, including paper-based and electronic records
Manage cross-functional stakeholder interactions effectively
Demonstrate strong organizational and prioritization skills in a fast-paced environment
Required Experience
8 to 14 years of hands-on experience in monoclonal antibody upstream process development using mammalian cell lines
Proven industry experience within biopharma, biotech, or contract research organizations
Educational Qualifications
MSc, MTech, or PhD in Biotechnology or a closely related discipline
Why Join Lambda Therapeutic Research
Work on advanced biologics and monoclonal antibody development programs
Lead high-impact projects supporting global clinical trials
Collaborate with international teams across regulated markets
Accelerate your leadership career within a globally expanding CRO
Apply Now to advance your career in biopharmaceutical process development with Lambda Therapeutic Research through thepharmadaily.com, your trusted global pharma and life sciences job portal.
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