Manager/Sr. Manager - R&D

Quality HR Services

10 - 15 years

8 - 10 Lacs

vadodara

Posted:1 day ago| Platform:

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Skills Required

r&d team management process development project management glp gmp

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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