Team Member/Ast. Manager - Capacity Planning Cipla

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

Role Overview: You will be responsible for building the required manufacturing footprint and production capacity based on future demand, developing adequate manufacturing strategy, and facilitating continuous and sustainable business growth. Key Responsibilities: - Analyze Strat-Plan to build capacity roadmap based on business forecast and strategic growth drivers, including capacity and demand deflection analysis in the last 1-2 years. - Make capacity corrections based on capacity adherence report and actual delivery, and identify and address constraints hampering serviceability through bottleneck identification. - Conduct QA/QC related capacity assessment and initiate necessary actions/app...

Posted 1 week ago

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Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Sr Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications. Your responsibilities will include: - Authoring and reviewing CMC sections of regulatory submissions such as INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. - Ensuring completeness and compliance of CMC sections within IND and IMPD applications based on regulatory guidance (FDA, EMA, ICH). - Providing peer review and mentorship to junior writers or team members to maintain consistency and scientific accuracy across deliverables. - Staying up...

Posted 1 month ago

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Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ...

Posted 3 months ago

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