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4 days ago


Hyderabad, India Aurigene Pharmaceutical Services Limited Full time

Role Overview - Position Title: Team Leader - Process R&D - Role Band : L1 - Location: Hyderabad Purpose: Lead the design, development, and scale-up of safe, robust, and cost-efficient chemical processes that meet client specifications for quality, yield, and timelines. Objective: Ensure on-time delivery with scientific rigor, data-driven decision-making, and measurable value addition across route selection, optimization, and tech transfer. Minimum Requirements - Education: PhD in Organic Chemistry with 10 + years of experience (Mandatory) - Business/Domain Understanding: Strong grasp of CDMO workflows, client expectations, IP awareness, and drug discovery/development interfaces (non-GMP to GMP handoffs). Areas of Responsibilities (AOR) AOR 1: Project Execution and Delivery - Plan and distribute daily/weekly experimental work, track plans vs. actuals and de-risk critical path tasks. - Review and interpret complex analytical datasets (e.g., HPLC/UPLC, GC, LC–MS, NMR) for mass balance, assay, purity, and chiral integrity; ensure data integrity and scientific traceability. - Coordinate with SCM, ARD, SHE, and E&M to align material availability, method readiness, safety clearances, and equipment uptime. - Forecast and ensure timely procurement of raw materials, solvents, and consumables with suitable alternates. AOR 2: Process Development, Troubleshooting, and Value Addition - Anticipate chemistry and scale-up risks; resolve issues using literature (Reaxys, SciFinder) and structured experimentation (e.g., DoE, mechanistic probes). - Map impurity genesis, fate, and purge; implement control strategies via reagent/solvent selection, stoichiometry, temperature profiles, and workup design. - Improve routes for safety, robustness, and COGS (e.g., step telescoping, solvent swaps, greener reagents, reduced PMI/E-factor). - Develop crystallization strategies (solvent/anti-solvent screening, seeding, supersaturation control) for polymorph selectivity and particle-size control; minimize column chromatography. AOR 3: Team and Laboratory Management - Provide day-to-day scientific mentorship; conduct technical reviews and ensure high-quality ELN documentation. - Build team competencies in key unit operations (e.g., hydrogenations, low-temperature chemistry, moisture/air-sensitive handling, continuous/flow where applicable). - Enforce GLP/SLP, PPE compliance, chemical hygiene, waste segregation, and instrument calibration; maintain audit readiness. - Escalate instrument downtime, safety hazards, or deviations impacting delivery or safety to the Group Leader promptly. AOR 4: Client Communication and Proposal Preparation - Prepare high-quality technical updates, data packages, and final dossiers with clear narratives, risks, and mitigation plans. - Lead/participate in client calls; communicate progress, deviations, and next-step experiments with timeline and resource implications. - Support proposals with feasible synthetic routes, preliminary control strategies, and realistic costing/throughput estimates within required TAT. AOR 5: Safety, Health, and Environment (SHE) - Comply fully with SHE guidelines; conduct risk assessments (e.g., thermal/pressure hazards), and define safe operating spaces. - Drive continuous improvement via incident/near-miss analysis, CAPA implementation, and periodic safety audits. AOR 6: People Management - Create a collaborative, high-performance environment with clear objectives and feedback. - Identify training needs, develop skill matrices and IDPs, and ensure completion of mandatory training. - Ensure smooth administration and adherence to organizational policies and procedures. Required Knowledge and Skills - Technical Expertise: Deep command of synthetic organic chemistry, route scouting, and lab-to-pilot scale-up principles. - Analytical Literacy: Proficient interpretation of NMR, LC–MS, HPLC/UPLC, GC, KF, and related in-process controls to drive decisions. - Literature and IP: Expert use of Reaxys and SciFinder; strong patent and prior-art orientation for route/source ability. - Software and Documentation: Proficient in Word, PowerPoint, Excel; disciplined ELN practices and data management. - Leadership: Proven ability to lead and develop 7–10 scientists/RAs; strong prioritization and resource levelling. - Communication: Clear scientific writing and presentation for internal stakeholders and external clients. - Problem Solving: Hypothesis-driven experimentation, DoE mindset, and data-driven optimization with clear acceptance criteria.



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