Manager/Sr. Manager - R&D

Job Description:

Position:          Manager/Sr. Manager - R&D

Location:         Vadodara

Experience:     10 - 15 Years

Industries:       Pharma

Responsibilities:

• Project & Team Management
• Lead and manage multiple API development projects across various stages (Route scouting, lab development, scale-up, validation).
• Plan and allocate resources effectively among chemists and analysts.
• Mentor and guide junior scientists on technical and professional development.
• Process Development & Optimization
• Design and optimize synthetic routes with focus on yield improvement, impurity profile, and cost reduction.
• Identify and develop alternate synthetic strategies to mitigate IP challenges or improve process efficiency.
• Develop robust and scalable processes suitable for commercial production.
• Technology Transfer
• Prepare technology transfer documents and support plant trials and commercial batches.
• Troubleshoot process-related issues during scale-up and manufacturing.
• Collaborate with manufacturing, QA, QC, and regulatory teams to ensure successful transfer.
• Regulatory & Documentation
• Ensure proper documentation as per GLP, GMP, and regulatory standards.
• Review and finalize development reports, protocols, process documents, and specifications.
• Support regulatory dossier preparation (DMFs, CTD sections) and respond to regulatory queries.
• Compliance & Safety
• Maintain compliance with safety protocols, EHS regulations, and cGMP norms.
• Conduct risk assessments and implement mitigation measures during development activities.
• Collaboration & Communication
• Work closely with cross-functional teams including QA, QC, Regulatory Affairs, and Production.
• Liaise with external partners, CROs, and consultants as needed.

Required Skills:

• Strong expertise in organic synthesis, route design, and process chemistry.
• Sound knowledge of regulatory requirements (USFDA, EDQM, WHO, etc.).
• Hands-on experience in impurity profiling and analytical data interpretation.
• Excellent leadership, project management, and communication skills.
• Proficiency with lab software and documentation systems.

Required Qualification: - B.Sc/M.Sc - Chemistry

Salary :- Upto 10.00 LPA

If you are interested in this opening, please send updated resume on same mail with following details.

Total No. of Years Experience: -

Current CTC: -

Expected CTC: -

Notice Period: -