Associate Director of Process Development, AFD

Associate Director of Process Development, AFD page is loaded## Associate Director of Process Development, AFDremote type:
On-site locations:
Fremont, CAtime type:
Full time posted on:
Posted 2 Days Agojob requisition :
R5204## The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve.

Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
** Company:
** Bionova Scientific LLC
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* Job Description:

**** Company

Summary:

** Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products.  As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals who are dedicated to advancing the field of Plasmid DNA process development and manufacturing.  

Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client challenges.

Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve.  Adaptability and an interest in transformative action are also common attributes among our team.
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* Position Summary:

** The Associate Director of Analytical and Formulation Development will be responsible for managing analytical activities in support of drug substance and drug product development. This position requires experience with clinical-stage product development, and method development/validation/transfer.
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* Essential Duties and Responsibilities:

*** Oversee and manage a team engaged in AFD and QC transfer activities. Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry and formulation development.
* Provide technical review of analytical data integrity, method development, and method validation protocols/reports.
* Represent functional CMC role and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of drug to support GLP toxicology studies and IND-enabling activities across a portfolio of programs.
* Act as primary liaison for analytical testing performed by external contract organizations and review data collected.
* Ensure that testing methodologies meet phase-appropriate cGMP requirements.
* Work with internal subject matter experts to author and review analytical test methods, protocols, and development reports.
* Review method transfer reports/qualification/validation plans and reports by clients.
* Author analytical CMC modules to support regulatory filings.
* Develop sensitive and robust analytical test methods to support release testing and characterization of drug products.
* Lead and guide the junior analysts for daily analytical activities.
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* Working Conditions:

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