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: The Sr. Director of Quality Control is a member of the Quality and Compliance Leadership Team responsible for leading Bionova Scientific’s QC function. This role sets strategy and provides oversight for sample management, stability, in-process and environmental monitoring, release testing, method transfer, qualification, validation, and related QC operations. The role supports client timelines by developing robust analytical transfer and qualification strategies in collaboration with clients and Bionova’s Analytical Development team. Location: Fremont, CA Benefits Direct Hire Medical, Dental, Vision, 401K (match up to 5%, plus an additional 3%, total 8%) Paid time off Annual Bonus eligible Primary Responsibilities: Provide strategic and tactical leadership for Bionova Scientific’s QC laboratories and related operations. Apply deep technical expertise in analytical methods to support development, clinical, and commercial testing, including troubleshooting and investigations. Ensure phase-appropriate compliance with global cGMP expectations for release, stability, and environmental monitoring programs. Partner with clients and internal teams to assess program risks and define analytical strategies that support timely, science-based decisions. Oversee method development, transfer, qualification, and validation for development and commercial programs. Partner with Quality Assurance to maintain fit-for-purpose QC quality systems and data integrity. Drive continuous improvement initiatives, performance metrics, and KPIs to improve laboratory efficiency, effectiveness, and process stability. Lead, coach, and develop the QC team to strengthen technical capability, compliance, and operational execution. Communicate goals, risks, decisions, and results effectively across development and commercial teams. Required Skills: Advanced degree in Pharmaceutics, Biochemistry, Chemistry, Biochemical Engineering, or a related discipline; equivalent experience may be considered. 15+ years of leadership experience in Analytical Sciences, Quality Control, or a related GMP laboratory environment. Strong understanding of biopharmaceutical development, from cell line generation through market authorization. Direct experience interacting with global regulatory agencies. Strong experience with method optimization, transfer, qualification, and validation for release and stability testing. Extensive knowledge of cGMP requirements and data integrity expectations. The base compensation range for this role is $240,000-$280,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions. #LI-MG1 #hybrid 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. Be cautious of fraudulent communications claiming to be from Asahi Kasei. Incidents have occurred in which individuals impersonating Asahi Kasei recruiters have contacted people on LinkedIn requesting personal information. If someone does not have a verification badge, that person is not authorized to engage in recruitment activities on behalf of Asahi Kasei. Please also note that we never ask applicants to make any payments in the recruitment process. If you receive any suspicious messages or recruitment outreach that does not meet these criteria, please do not respond, and report the matter directly to LinkedIn. Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us. As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees. Our People Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions. For assistance in submitting your application or with the careers site, please reach out to Asahi-WFP@ak-america.com. Please note we do not accept resumes or applications via email. Don't see an opening that matches your skills? Setup job alerts by selecting Sign In, located in the upper right of the page, to create an account.

Sr. Director of Quality Control.

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