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.  As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals who are dedicated to advancing the field of Plasmid DNA process development and manufacturing.  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 challenges.

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.

Position Summary:

This role presents a unique opportunity to establish the foundation and set direction for the facility currently being designed and constructed. The role will be responsible for leading quality control activities, staffing the functional area, and building the infrastructure to enable on-time and within budget execution and completion of future client projects.  Partnering closely with cross-functional representatives and clients, this role will enable Plasmid DNA testing activities are completed per agreed upon timelines and deliverables. 
As a manager of the QC team, you will be able to influence decisions and develop your own talent with the team to meet project goals that ultimately will improve patient outcomes.

Essential Duties and Responsibilities:

• Establish Plasmid DNA QC laboratories, including selecting equipment, setting up layouts and workflows, and ensuring alignment with industry standards and safety protocols.
• Recruit, train, and lead a team of scientists and associates responsible for QC activities. Provide guidance, mentorship, and performance feedback.

• Ensure all testing activities adhere to applicable regulatory guidance and industry best practices.
• Compile and/or support the creation of documentation for regulatory submissions.
• Collaborate with cross-functional teams and clients, including Manufacturing, Process development, Analytical Development, Quality Assurance, Program Management, and Business Development to ensure alignment of analytical method qualification and testing activities with overall company and client objectives.

• Prepare and present concise, sound scientific presentations of testing data to the internal and external team for decision making.
• Face-to-face interaction with clients to discuss laboratory capabilities and provide feedback.
• Author technical documents such as laboratory and assay SOPs, method transfer protocols/reports, and method qualification protocols/reports.
• Manage/perform general laboratory duties associated with equipment maintenance and good housekeeping.
• Establishment of select QC functions through implementation of GMP procedures, processes, and systems.
• Manage a team of QC analysts, mentor and train staff members based upon prior experience level.
• Oversee day-to-day operations of the department and direct reports.
• Manage/Perform QC testing to support GMP production, raw material testing, facility controls (environmental monitoring), stability studies, and standalone QC testing projects.
• Manage/author of deviations, CAPAs and change controls. 
• Lead or oversee method transfer and qualification of analytical test methods (HPLC/UPLC, CE-SDS, SDS-PAGE, PCR, ELISA, Sequencing and others) as required.
• Project management and coordination of various high impact internal and external projects where analytical/Micro/EM input is valued.
• Author/review/approve technical documents such as method validation and qualification protocols/reports, and regulatory filing documents per project needs.
• Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
• Lead select QC function meetings with clients to move projects forward and/or triage issues.
• Evaluate new technologies and innovations to improve operational efficiency or expand QC capabilities.
• Interpret/review analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to manufacturing.
• Represent the QC function during inspections from regulatory agencies and client audits.

Working Conditions:

• This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching.  The employee must occasionally lift and or move up to 20 pounds independently.
• Initially, remote working conditions transitioning to long term permanent, onsite position; occasional travel.

Qualifications:

• BS, MS or PhD in Pharmaceutical Sciences, Chemistry, Biophysics or Biochemistry with 10+ years for BS, 7+ years for MS and 5+ year for PhD of relevant research and/or industry experience.
• 3-5 years of people leadership or managing people in direct reporting roles or in matrix organizations.
• In-depth understanding of analytical and microbial test methods and industry-standard analytical tools (HPLC/UPLC, sequencing, PCR, ELISA, microbiological assays, compendial assays, etc.).
• Experience with new laboratory start-up and equipment commissioning. 
• Hands-on experience in running, qualifying, and validating analytical methods.
• Creative thinker that can identify and efficiently improve methods to address issues and gaps.
• Demonstrate ability to work independently and on cross-functional teams.
• Proven client interactions and project management experience desired.
• Strong attention to detail.
• Effective verbal and written communication skills.

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.