Deputy General Manager – Downstream
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Department: Biopharma / Process Development
Employment Type: Full-Time
Experience: 13+ years of experience with M.Tech + PhD in Biochemical Engineering or equivalent, or 15+ years of experience with B.Sc./M.Sc. in Biochemical Engineering or related disciplines, with strong expertise in monoclonal antibody (mAb) downstream process development.
Salary Package: ₹30–55 LPA (As per company CTC range; final compensation depends on candidate experience, technical expertise, and leadership capabilities.)
Role Overview
The Deputy General Manager – Downstream is responsible for providing technical leadership in downstream process development for monoclonal antibody (mAb) purification. The role involves leading development activities across purification platforms, process characterization, scale-up, regulatory support, and technology innovation to enable preclinical and clinical development programs.
Key Responsibilities
Downstream Process Development Leadership
Provide technical leadership for downstream process development activities for monoclonal antibody (mAb) purification.
Lead development and optimization of downstream unit operations, including:
Clarification
Chromatography
Tangential Flow Filtration (TFF)
Formulation development
Develop robust purification processes for mAbs and advanced molecules such as bispecific antibodies.
Drive process improvements and implementation of innovative purification technologies.
Process Development & Optimization
Develop and execute:
Consistency batches
Engineering campaigns
Clinical trial manufacturing campaigns
Drug substance (DS) generation for preclinical and clinical studies
Support process characterization using Quality by Design (QbD) principles.
Perform process capability studies and establish robust manufacturing processes.
Lead cleaning validation activities and resin/TFF reuse studies.
Evaluate emerging technologies for cost-effective and scalable purification solutions.
Viral Clearance & Regulatory Support
Collaborate with CROs and external partners for viral clearance studies.
Review and support viral validation activities.
Author and review technical reports related to:
mAb purification processes
Downstream unit operations
Viral clearance studies
Regulatory submission documents
Support preparation of IND-enabling data packages for early clinical development programs.
Technical Documentation & Compliance
Prepare, review, and approve technical reports and process development documentation.
Ensure scientific data is accurately documented and aligned with regulatory expectations.
Support regulatory submissions through technical input and documentation review.
Maintain compliance with applicable quality and regulatory standards.
Team Leadership & Development
Build, develop, and manage a highly skilled downstream process development team.
Mentor team members and support technical and professional growth.
Provide guidance to scientists and engineers in executing development activities.
Promote innovation, technical excellence, and continuous improvement.
Educational Qualification
Preferred Qualification:
M.Tech + PhD in Biochemical Engineering or equivalent discipline.
Alternative Qualification:
B.Sc./M.Sc. in Biochemical Engineering, Biotechnology, Biochemistry, or related field with extensive relevant experience.
Required Experience
13+ years of experience with M.Tech + PhD qualification, or
15+ years of experience with B.Sc./M.Sc. qualification.
Strong experience in downstream process development for monoclonal antibodies.
Experience with mammalian cell culture-derived biopharmaceutical products.
Experience in:
Chromatography process development
TFF operations
Purification process optimization
Viral clearance studies
Process characterization
Scale-up activities
Technical Skills
Expert knowledge of mAb downstream purification processes.
Strong understanding of biopharmaceutical manufacturing processes.
Hands-on experience with:
Protein purification platforms
Chromatography technologies
Filtration technologies
Process scale-up and optimization
QbD-based process development
Knowledge of regulatory expectations for biologics development.
Experience preparing technical documentation and regulatory support packages.
Leadership Competencies
Strong scientific and technical leadership skills.
Ability to manage and mentor multidisciplinary teams.
Excellent problem-solving and decision-making abilities.
Strong collaboration skills with internal teams and external CRO partners.
Ability to drive innovation and technology improvements.
Excellent communication and stakeholder management skills.
Strategic thinking with strong execution capabilities.
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