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Senior Manager

Lambda Research Accelerated
Lambda Research accelerated
8-14 years
preferred by company
10 Dec. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.