Dear Kim and PQC Leadership Team,
I hope you are doing well. I am very much interersted for this volunteer oppertunity.
With over 15 years of experience in pharmaceutical development-spanning sterile injectables, drug–device combination products, CMC strategy, analytical method development, and regulatory interactions-I have worked extensively on setting, justifying, and lifecycle‑managing product specifications across multiple modalities. I have also collaborated with CDMOs, supported NDA/ANDA submissions, and contributed to quality‑by‑design and control strategy development.
I am particularly interested in helping facilitate discussions, share practical case studies, and support activities that strengthen understanding of evolving regulatory expectations around specifications. I would be happy to assist with webinars, online discussions, or any collaborative efforts the team plans to undertake.
Please let me know if any additional information would be helpful. I would be glad to support the PQC community in this initiative.
Warm regards,
Bhasker Sambar
LinkedIn: https://www.linkedin.com/in/bhasker-sambar-b5052933
Email: [email protected]
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Bhasker Sambar
Sr. Manager, External R&D and Technical Services
Alvogen INC
Exton PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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