Job Title: Technical Lead – Upstream Development
Job Category: Biopharmaceutical Research & Development / Upstream Process Development
Location: Ahmedabad, Gujarat, India
Req ID: 1391
CTC Range: INR 10,00,000 – 15,00,000 per annum
Company Overview
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The organization delivers integrated, end-to-end clinical research solutions to innovator, biotech, and generic pharmaceutical companies worldwide.
With strategic operations across India, North America, and Europe—including Mehsana, Las Vegas, Toronto, Barcelona, London, and Warsaw—the company supports global drug development programs through regulatory-compliant infrastructure and scientific excellence.
Role Overview
We are seeking an experienced Technical Lead – Upstream Development to drive mammalian cell culture–based monoclonal antibody (mAb) upstream process development programs. This role requires strong expertise in GMP-compliant bioprocessing, process optimization, scale-up execution, data analysis, and technical leadership within a biopharma or CRO setting.
Key Responsibilities
Lead sterile mammalian cell culture operations and upstream development activities.
Manage autoclaving, stirred tank reactor (STR) systems, and wave bioreactor setup, including calibration and maintenance.
Operate and optimize AMBR 15 and AMBR 250 systems for clone screening and process optimization.
Execute scale-up and consistency batches using 50L and 200L disposable bioreactors in GMP suites.
Handle process analytical instruments including Vi-Cell analyzer, BGA, and CEDEX systems.
Optimize processes to achieve targeted Critical Quality Attributes (CQA) and improve productivity.
Apply Quality by Design (QbD) principles for process characterization and scale-up/down strategies.
Utilize DOE software such as Minitab and JMP for statistical modeling and process analysis.
Prepare and review technical protocols, process development reports, electronic lab notebooks, and CAPA documentation.
Support technology transfer, troubleshooting, deviation management, and lab compliance.
Provide technical guidance and lead upstream development teams when required.
Required Experience
6 to 10 years of hands-on experience in monoclonal antibody (mAb) upstream process development using mammalian cell lines.
Experience in biopharmaceutical, biotechnology, or contract research organizations.
Proven expertise in AMBR systems and large-scale disposable bioreactors (50L and 200L).
Prior team leadership experience in mAb upstream processing is strongly preferred.
Strong technical writing and GMP documentation skills.
Educational Qualification
MSc / MTech / PhD in Biotechnology or a related life sciences discipline.
Qualified professionals seeking leadership opportunities in biologics upstream development are encouraged to apply through ThePharmaDaily.com for confidential consideration.
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