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Team Leader - Process Research And Development

10-15 years
Not Disclosed
10 Jan. 27, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here is a more polished version of the Team Leader - Jubilant Biosys Noida-PRD job description:


Job Title: Team Leader - Process Research and Development (PRD)
Location: Noida, India
Company: Jubilant Biosys

Job Description:
Jubilant Biosys is seeking a highly skilled and experienced Team Leader for our Process Research and Development (PRD) team. This leadership position involves overseeing the development and scaling of New Chemical Entities (NCEs), Drug Candidates, and APIs. As the Team Leader, you will drive scientific and technical solutions, lead process development from lab scale to commercial production, and guide the team towards successful project execution in alignment with client needs and company objectives.

Key Responsibilities:

  • Ensure Compliance with Safety, Health, and Environmental (SHE) Standards: Lead departmental adherence to SHE rules and regulations, provide training, monitor compliance, and report workplace incidents, injuries, and accidents immediately.
  • Lead R&D Teams: Manage and guide R&D teams in the Process Research and Development of Early Stage/Late Stage Route Selection and Scale-up of NCEs, Drug Candidates, and APIs.
  • Solve Technical and Scientific Challenges: Provide leadership in addressing complex and interdependent technical challenges across multiple projects, ensuring efficient resolution.
  • Process Development Expertise: Possess a strong understanding of Route Scouting (Alternate/Non-Infringing RoS), Process Research and Development, and Technology Transfer from lab scale to Kilo Lab, Pilot Plant, and ultimately to Commercial Production.
  • Collaborate Across Departments: Develop and execute process research project plans in coordination with teams such as Analytical Services, Operations, Scale-up, GMP, and Quality Assurance.
  • Utilize QbD/DoE Tools: Apply Quality by Design (QbD) and Design of Experiments (DoE) tools and techniques for effective process research.
  • Interpret Analytical Data: Demonstrate proficiency in interpreting data from various analytical techniques such as NMR, MS, IR, GC, HPLC, and Solid-State Characterization (XRD, DSC, TGA, PSD, etc.).
  • Project Monitoring and Review: Track project progress using tools such as status meetings, scientific presentations, Gantt charts, and regularly review project timelines, budgets, and deliverables.
  • Contribute to Project Success: Actively contribute to project outcomes by reviewing lab-scale efforts, overseeing scale-up processes, and ensuring that projects stay on track and within budget.
  • Facilitate Technology Transfer: Collaborate with Technology Transfer, Scale-up, and GMP Manufacturing teams to ensure the smooth transition of processes to larger production scales.
  • Client Communication: Serve as a key point of contact for clients on scientific and technical matters related to ongoing projects, ensuring satisfaction and timely updates.
  • Prepare Project Reports: Manage and review weekly/bi-weekly updates, campaign reports, Process Development Reports (PDR), and Technology Transfer Documentation (TTD) for successful transfer to pilot plant and final project reports.
  • Departmental Leadership: Lead or contribute to key departmental initiatives and responsibilities as assigned by the Director of PRD and Scale-up.
  • Support Business Development: Assist in identifying new business opportunities by collaborating with the Business Development team on RfPs/RfQs.

Qualifications and Experience:

  • Education: M.Sc, Ph.D., or Post-Doc in Organic Chemistry or a related field.
  • Experience: 10-15 years of industrial experience in Process Research and Development of NCEs, Drug Candidates, and APIs within a CRDMO/CRAMS environment.
  • Technical Expertise: In-depth knowledge of route scouting, technology transfer, and scale-up processes, with proven experience leading projects through lab-scale, pilot, and commercial production stages.

Equal Opportunity Employer:
Jubilant Biosys is committed to fostering a diverse workforce. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, color, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion, or any other characteristic protected by applicable local laws, regulations, and ordinances.