Process R&D and ADL Scientist - API
Talental Consultings · Vapi, India
Job Description
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
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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
. Skillset Required: 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 CollaborationDetails
| Company | Talental Consultings |
| Location | Vapi, India |
| Type | FULL TIME |
| Niche | general |
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