QC Director
Bionova Scientific LLC

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

Job Description:

Position Summary:
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 validation.

Primary Responsibilities:

• 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 stability testing.
• 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 met.
• 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 organization.

Required Skills:

• Advanced degree in Pharmaceutics, Biochemistry, Physical Chemistry, Organic Chemistry, Biochemical Engineering, or related experience.
• 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 required
• 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 position.

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.

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