Deputy Manager – Downstream Process Development
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Department: Process Sciences / Biopharma Development
Employment Type: Full-Time
Experience: 6–10 years of experience in monoclonal antibody (mAb) purification process development from mammalian cell lines within biopharma, biotech, or relevant contract research organizations.
Salary Package: ₹10–15 LPA (As per company CTC range; final compensation depends on candidate experience, technical expertise, and leadership capabilities.)
Role Overview
The Deputy Manager – Downstream Process Development is responsible for designing, executing, and analyzing experiments related to monoclonal antibody (mAb) downstream processing within the Process Sciences group. The role involves leading purification process development activities, managing technical teams, optimizing purification technologies, and supporting clinical-grade drug substance manufacturing.
Key Responsibilities
Downstream Process Development
Lead development activities for monoclonal antibody purification processes.
Design, execute, and analyze experiments related to downstream processing.
Manage multiple downstream unit operations for manufacturing clinical-grade drug substances.
Develop and optimize cost-effective purification technologies for mAbs.
Evaluate emerging technologies for capture and purification of monoclonal antibodies.
Purification Process Management
Oversee operation and maintenance of purification skids and chromatography columns across:
Laboratory scale
Pilot scale
Manufacturing scale
Manage purification materials including:
Chromatography resins
Filtration cassettes
Other purification consumables
Ensure availability and proper management of purification resources.
Support process optimization and improvement initiatives.
Process Characterization & Data Analysis
Utilize statistical tools to evaluate:
Process performance
Process consistency
Process robustness
Apply scientific and engineering principles for process understanding and optimization.
Support process characterization studies and development activities.
Use automation software and tools for purification process operations.
Viral Clearance & Regulatory Support
Collaborate with external CROs for execution of viral clearance studies.
Review and author technical reports related to:
mAb purification processes
Downstream unit operations
Viral clearance studies
Regulatory submission sections
Support IND-enabling data generation for early clinical development programs.
Technology Transfer & GMP Support
Assist in technology transfer of developed purification processes to:
Pilot manufacturing facilities
GMP manufacturing facilities
Apply understanding of GMP requirements for mAb purification processes.
Support clinical-grade drug substance manufacturing activities.
Ensure processes are developed with scalability and regulatory compliance in mind.
Team Leadership & Collaboration
Lead and guide downstream process development team members.
Provide technical mentoring and support to scientists and engineers.
Collaborate with internal teams and external partners.
Drive innovation and continuous improvement within process development activities.
Educational Qualification
Preferred Qualifications:
B.E. in:
Biochemical Engineering
Chemical Engineering
OR
M.Tech with PhD in:
Biochemical Engineering
Biological Sciences
Related disciplines
Required Experience
6–10 years of experience in:
mAb purification process development
Downstream processing
Mammalian cell line-derived biopharmaceutical products
Experience in biopharma, biotechnology, or CRO environments.
Prior experience leading a team focused on mAb downstream operations is preferred.
Technical Skills
Strong expertise in mAb downstream purification processes.
Hands-on knowledge of:
Chromatography operations
Filtration technologies
Purification process optimization
Process scale-up activities
GMP manufacturing practices
Understanding of automation software used for purification operations.
Experience with statistical tools for process analysis.
Knowledge of viral clearance studies and regulatory documentation.
Key Competencies
Strong technical and scientific problem-solving skills.
Ability to lead and mentor technical teams.
Excellent analytical and data interpretation abilities.
Strong understanding of bioprocess development principles.
Good documentation and report-writing skills.
Ability to manage multiple development activities.
Strong collaboration and communication skills.
Innovation-driven approach with focus on process excellence.
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