Process R&D and ADL Scientist API
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Job Summary
Job Title
Process R&D and ADL Scientist - API
Description
We are a leading pharmaceutical company based in Vapi seeking an experienced Process R&D Scientist with an API background to support Process Research & Development and Analytical R&D (ARD) activities. The successful candidate will drive laboratory and pilot-scale development of synthetic routes optimize processes for safety and manufacturability and partner with analytical teams to develop and validate methods that ensure product quality and regulatory compliance.
Responsibilities
Position: Sr. Executive / Asst. Manager
Dept.: Process R&D
Major Job Role:
- Strong expertise in route scouting process development optimization and scale-up of APIs and intermediates.
- Hands-on experience in technology transfer pilot plant batches and process troubleshooting.
- Sound knowledge of impurity control crystallization and process validation activities.
- Ability to independently lead development projects and mentor a team of scientists/executives.
- Good understanding of regulatory requirements development documentation and cross-functional coordination.
Position: Sr. Executive / Asst. Manager
Dept.: ADL
Major Job Role:
- Expertise in method development validation transfer and troubleshooting for HPLC GC UPLC KF UV and related analytical techniques.
- Strong understanding of ICH USP EP and regulatory requirements.
- Experience in impurity profiling stability studies cleaning validation and analytical support for process development.
- Ability to lead a team of analysts/scientists and manage multiple projects simultaneously.
- Experience in preparing and reviewing analytical development reports AMV protocols/reports and regulatory documentation.
Location: Vapi Gujarat India
Required Skills:
Process Research and Development Analytical Research and Development API Development Process Development and Scale-up Technology Transfer Process Optimization Reaction Engineering Synthetic Organic Chemistry Crystallization and Polymorphism Solid-state Characterization HPLC Method Development GC Method Development Analytical Method Validation Stability Studies cGMP Compliance Regulatory Submissions Process Analytical Technology (PAT) Design of Experiments (DOE) Statistical Data Analysis Root Cause Investigation Risk Assessment (FMEA) Process Safety Quality by Design (QbD) Analytical Instrumentation Process Documentation and Batch Records Project Management Team Leadership Cross-functional Collaboration
