Sr. Director of QC
Bionova Scientific LLC

Job Info

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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 Quality Control role is a member of the Quality and Compliance Leadership Team and is accountable for leading the Bionova Scientific's Quality Control function. The incumbent leads and outlines the strategy for all aspects of the QC operation including sample management, stability program, in process monitoring, environmental monitoring, release testing, method transfer, method qualification, method validation, etc.

The Sr. Director of QC plays a critical role in supporting clients' timelines and as such establishes the method transfer and method qualification strategy in collaboration with clients and the Bionova Analytical Development team.

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, clinical 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 fit for purpose Quality Systems for in-house QC labs. Ensures data integrity in the QC lab operations.
• 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, development, 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.

Working Conditions:

• This position is required to work in an office and laboratory setting.

Required Skills:

• Advanced degree in Pharmaceutics, Biochemistry, Physical Chemistry, Organic Chemistry, Biochemical Engineering, or related experience.
• 15+ 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 method optimization, method transfer and method qualification and validation for drug substance/drug product release and stability testing is required
• Extensive experience and knowledge of GMPs is required

Compensation Range: The base compensation range for this role is between $180,000 and $230,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

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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