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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Original Message:
Sent: 05-04-2026 10:51
From: Kim Huynh-Ba
Subject: Call for Volunteers – Scientific Team: Specifications of Pharmaceutical Products
Join us in building a collaborative scientific team focused on pharmaceutical product specifications. This group will create a forum to discuss real-world challenges, evolving regulatory expectations, and practical approaches across the lifecycle. Our goal is to spark meaningful conversations, expand professional networks, and learn from each other's experiences.
We are looking for enthusiastic volunteers to help lead and shape this team-organizing webinars, facilitating online discussions, and developing activities based on shared interests. Activities are intentionally flexible and will be defined by the team. Leadership and responsibilities can be shared, and no long-term commitment is required.
If interested, please contact Chair/Vice Chair of the Pharmaceutical Quality Community.
Bests,
Kim
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Kim Huynh-Ba, MS, PMP, FAAPS
Pharmalytik LLC, Managing Director
Temple University, RAQA, Adjunct Professor
Illinois Institute of Technology, Adjunct Professor
[email protected]
Newark DE - USA
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