Company: Asahi Kasei Corporation
Posted on: January 26, 2023
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.
Bionova Scientific LLC
The Senior Director Analytical Laboratory Services role is part of
our Quality and Compliance organization responsible to lead Bionova
Scientific's analytical laboratories across the entire CDMO
organization. They are directly accountable for leading all
analytical development, process development analytical support, and
QC testing. These activities include raw material testing,
in-process monitoring, facility monitoring, product release, method
development, method transfer, method qualification, and method
- Ensure the success of the of Bionova Scientific's analytical
laboratories through strategic and tactical leadership.
- Demonstrate a comprehensive understanding of analytical test
methods used in development and commercial product testing to
enable prompt and effective transfers and troubleshooting of
methods and investigations.
- Demonstrate a deep understanding of the phase appropriate
global cGMP regulations and expectations surrounding release and
- Work closely with internal teams and clients to assess program
risks and develop analytical strategies.
- Support development of new and existing methods for development
and commercial programs and transfer of methods from/to partners to
ensure that the phase appropriate testing expectations are
- Work closely with Quality Assurance colleagues in establishing
appropriate Quality Systems for in-house QC labs.
- Work closely with process Development colleagues in
establishing appropriate analytical support for dynamic,
accelerated process decisions.
- Define and execute on continuous improvement opportunities for
QC laboratory to drive efficiencies in operations.
- Establish clear expectations, metrics and KPIs, to monitor
business process performance and stability.
- Provide leadership, coaching and guidance to the team.
- Be an effective communicator of ideas, project goals and
results to team members across the development and commercial
- Advanced degree in Pharmaceutics, Biochemistry, Physical
Chemistry, Organic Chemistry, Biochemical Engineering, or related
- 10+ years of experience leading and managing large teams in a
AS/QC environment is required
- Experience with direct interaction with global regulatory
agencies is required
- Experience with analytical method validation and optimization
for drug substance/drug product release and stability testing is
- Experience with applying the principles and techniques of
analytical chemistry is required
- Extensive experience and knowledge of GMPs is required
Compensation: The expected annual base compensation for this role
is: $180,000 - 210,000. Actual base compensation within the
identified range will vary based on factors relevant to the
As an equal opportunity employer, Asahi Kasei believes a diverse
workforce will provide us with the ability to continuously support
the changes in the economy, society, and environment.
Keywords: Asahi Kasei Corporation, Fremont , QC Director, Executive , Fremont, California
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