Kreative Organics Pvt. Ltd.
Website:
kreativeorganics.com
Job details:
Job Title:
Team Leader – Peptide Synthesis (CRO/CDMO)
Location:
University of Hyderabad, Hyderabad, India
Department:
Research & Development (R&D)
Employment Type:
Full-Time
Job Summary
The Team Leader – Peptide Synthesis will be responsible for leading peptide synthesis projects from route development to scale-up in a CRO/CDMO environment. The role involves supervising a team of scientists, driving process optimization, ensuring quality and regulatory compliance, and delivering projects to meet client and business objectives.
Key Responsibilities
• Peptide Process Development: Lead the design and development of synthetic routes for linear and complex peptides using SPPS and solution-phase synthesis for CRO/CDMO client projects.
• Team Leadership & Mentoring: Manage, mentor, and guide a team of scientists/executives to achieve project goals, timelines, and quality standards.
• Process Optimization & Scale-Up: Optimize reaction conditions, coupling strategies, purification processes, and scale-up peptide synthesis from lab to pilot/commercial scale at CDMO facilities.
• Project & Client Management: Handle multiple CRO/CDMO projects, participate in technical discussions with clients, and ensure timely delivery of project milestones.
• Technology Transfer: Support seamless transfer of peptide processes from R&D to manufacturing, including documentation and troubleshooting.
• Regulatory & Documentation: Prepare and review technical reports, development summaries, SOPs, and contribute to regulatory submissions (DMF, CMC documentation) for client filings.
• Quality, Safety & Compliance: Ensure adherence to GLP, GMP guidelines, and safety protocols within the laboratory.
• Cross-Functional Collaboration: Work closely with QA, QC, Analytical, and Regulatory Affairs teams to support development and commercialization activities.
Qualifications & Experience
• Education: M.Sc. / Ph.D. in Organic Chemistry, Peptide Chemistry, or related discipline.
• Experience: 10 years of relevant experience (M.Sc.) or 5 years (Ph.D.) in peptide synthesis within a CRO, CDMO, or pharmaceutical industry, including 2+ years in a leadership role.
Technical Skills
• Strong expertise in solid-phase peptide synthesis (SPPS) and solution-phase synthesis
• Knowledge of coupling reagents, protecting groups, and peptide purification techniques (HPLC, prep-HPLC)
• Hands-on experience with analytical techniques such as HPLC, LC-MS, NMR, IR
• Understanding of scale-up challenges, impurity profiling, and yield optimization
• Knowledge of GMP/ICH guidelines related to peptide manufacturing in CRO/CDMO settings
Soft Skills
• Strong leadership and people-management skills
• Excellent problem-solving and decision-making abilities
• Effective communication and client-interfacing skills
• Ability to manage multiple projects in a fast-paced CRO/CDMO environment
• High level of accountability and quality mindset
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