18 Sep
|
Talental Consultings
|
Vapi
18 Sep
Talental Consultings
Vapi
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.
- Robust 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
📌 Process R&D and ADL Scientist (Vapi)
🏢 Talental Consultings
📍 Vapi