Manager, Upstream Process Development, Plasmid DNA

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 upstream process development 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 ensure Plasmid DNA development activities are completed per agreed upon timelines and deliverables. Essential Duties and

Responsibilities:

· Establish Plasmid DNA upstream 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 upstream development activities.

• Provide guidance, mentorship, and performance feedback.

· Lead the development efforts to optimize upstream capability. This involves designing experiments, analyzing data, and making recommendations for improvements. · Lead a team of scientists to design, develop and implement development and optimization work for both internal and external client projects.

· Facilitate the seamless transfer of developed processes to manufacturing teams, providing detailed documentation, training, and ongoing support. · Ensure all upstream development 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, Quality Control, Quality Assurance, Program Management, and Business Development to ensure alignment of upstream development activities with overall company and client objectives. · Support investigations via equipment troubleshooting and testing to identify root causes.

· Prepare and present concise, sound scientific presentations of study results 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 equipment SOPs (Standard Operating Procedures), batch records, process development reports, and transfer protocols/reports.

· Evaluate new technologies and innovations to improve operational efficiency or expand upstream development capabilities. · Perform general laboratory duties associated with equipment maintenance and good housekeeping. · Keep abreast of industry trends, emerging technologies, and best practices in Plasmid DNA development to ensure the company remains competitive and innovative.

• Present or publish within the industry as appropriate.

Working Conditions: · This position is 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 Biology, Chemical Engineering, Microbiology 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 upstream and upstream process development (upstream controllers, tangential flow filtration (TFF) systems, centrifugation, cell lysis and single use technologies). ·

Experience:

with new laboratory start-up and equipment commissioning. · Hands-on

experience:

in running and developing upstream processes. · Creative thinker that can identify and efficiently improve processes 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. 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.

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skills:

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