Head of Manufacturing, Biologics

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:

Company Summary:

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. Teamwork, adaptability and an interest in transformative action are also common attributes among our team.

Position Summary:

Bionova Scientific is seeking a dynamic, experienced Head of Manufacturing to lead and expand our GMP manufacturing operations. This leader will oversee manufacturing activities for clinical and commercial biologics production, ensuring operational excellence, regulatory compliance, and continuous improvement in a fast-paced and growing environment.

This is a great Opportunity to play a critical leadership role in a rapidly growing organization.

Bionova offers a collaborative, entrepreneurial culture committed to scientific innovation and operational excellence with competitive compensation, benefits, and professional growth opportunities.

Essential Duties and Responsibilities:

• Lead and manage all aspects of GMP manufacturing operations, including upstream and downstream production.
• Oversee manufacturing planning, scheduling, and execution to meet project timelines and quality standards.
• Ensure compliance with cGMP regulations, internal SOPs, and client-specific requirements.
• Develop, mentor, and manage the manufacturing leadership team and broader staff to foster a high-performing, collaborative culture.
• Collaborate closely with Process Development, Quality, Facilities, and Program Management to ensure seamless technology transfer and campaign execution.
• Drive continuous improvement initiatives in manufacturing processes, operational efficiency, and cost management.
• Contribute to strategic site planning and capacity expansion efforts, including facility design input and organizational scaling as needed.
• Establish and track key performance indicators (KPIs) for manufacturing operations.
• Serve as a key point of contact for clients during technical discussions, audits, and business development activities.

Working Conditions:

• This position requires work in an office and GMP manufacturing environment.  The employee must occasionally lift and or move up to 20 pounds independently. 

Qualifications:

• Bachelor’s degree in engineering, Biology, Biochemistry, or related field; advanced degree (MS, PhD, MBA) preferred.
• 20+ years of experience in biologics manufacturing within a GMP environment, with at least 5 years in senior leadership roles.
• Strong expertise in mammalian cell culture, protein purification, and single-use technologies.
• Demonstrated success in building and scaling manufacturing organizations and facilities.
• In-depth knowledge of cGMP regulations, I