Job Description

Roles and Responsibilities - Team Leader / Senior Scientist (Biosimilar R&D)
1. Strategic and Program Leadership
? Define and own the end-to-end biosimilar R&D strategy aligned with business, funding,
and regulatory objectives
? Identify and prioritize biosimilar candidates based on market opportunity, patent
landscape, development complexity, and technical feasibility
? Develop a phased development roadmap covering discovery, CMC, preclinical, and
clinical readiness
? Translate commercial goals into scientifically and regulatorily robust development
plans
2. Establishment of R&D Infrastructure
? Design and set up biosimilar R&D laboratories from scratch, including layout,
equipment selection, and utilities planning
? Establish SOPs, workflows, documentation systems, and data integrity practices
? Implement QbD and risk-based development approaches from early-stage R&D
3. Cell Line Development and Expression
? Lead host cell selection, vector design, and expression system strategy
? Oversee stable cell line development, clone screening, and selection based on
productivity and quality attributes
? Ensure genetic stability, productivity consistency, and scalability of selected clones
4. Upstream Process Development
? Design and optimize fed-batch and/or perfusion processes
? Develop scalable, robust, and cost-effective upstream processes suitable for
commercial manufacturing
? Establish process characterization, control strategies, and scale-down models
5. Downstream Process Development
? Design purification strategies to achieve target purity, yield, and product quality
? Develop chromatography and filtration processes aligned with biosimilarity
requirements
? Ensure process robustness, impurity clearance, and viral safety considerations
6. Analytical Characterization and Biosimilarity
? Define critical quality attributes (CQAs) and analytical comparability strategy
? Establish physicochemical, functional, and biological characterization platforms
? Oversee method development, qualification, and validation as per ICH and regulatory
guidelines
? Integrate analytical data to support biosimilarity claims against reference products
7. Formulation and Stability Development
? Lead formulation development to ensure product stability, compatibility, and shelf life
? Design and oversee forced degradation and long-term stability studies

? Support selection of final drug substance and drug product formulations

8. Preclinical and Clinical Enabling Support ? Define preclinical comparability and bridging strategies ? Coordinate in vitro and in vivo pharmacology, PK/PD, and immunogenicity studies ? Support clinical trial material readiness and comparability justification 9. Regulatory and Quality Compliance ? Ensure GLP, GxP, and data integrity compliance across all R&D activities ? Prepare and review CMC sections for IND, CTA, IMPD, and BLA submissions ? Support regulatory interactions, scientific advice meetings, and audit readiness 10. External Partnerships and CRO Management ? Identify, onboard, and manage CROs, CDMOs, and technology partners ? Oversee outsourced studies, ensuring timelines, quality, and cost control ? Act as the primary technical interface with external collaborators 11. Team Building and People Leadership ? Recruit, mentor, and develop multidisciplinary R&D teams ? Build a high-performance, startup-oriented scientific culture ? Set clear goals, KPIs, and performance metrics for team members 12. Budgeting and Resource Management ? Prepare R&D budgets and manage cost-effective execution ? Optimize resource utilization in a capital-constrained startup environment ? Manage procurement, vendor negotiations, and inventory planning 13. Tech Transfer and Scale-Up ? Lead process transfer from R&D to pilot and commercial manufacturing ? Prepare comprehensive tech transfer packages and validation support ? Support scale-up activities at internal facilities or CDMOs 14. Cross-Functional Collaboration ? Work closely with QA, Regulatory, Manufacturing, BD, and Finance teams ? Ensure alignment between R&D timelines and business milestones ? Support commercial readiness and lifecycle management strategies 15. Intellectual Property and Scientific Communication ? Support IP strategy, invention disclosures, and patent filings ? Contribute to grant proposals, investor presentations, and due diligence ? Represent the company in scientific, technical, and investor interactions

Job Types: Full-time, Permanent

Pay: ₹20,000.00 - ₹50,000.00 per month

Work Location: In person