Lead Scientist II, Process Development, pDNA
Bionova Scientific LLC

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:

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:

We are seeking a highly skilled and execution-focused Lead Scientist in Upstream Process Development (USP) and MSAT for Plasmid DNA. This role provides technical leadership and scientific direction across upstream development and MSAT activities within the site.

The Lead Scientist will play a critical role in designing, optimizing, and scaling upstream processes, while supporting robust tech transfer from PD to GMP. This position operates with a strong on-the-floor presence and partners cross-functionally to ensure high-quality, timely delivery of client programs.

This role does not have direct administrative or people management responsibilities but is expected to mentor and guide scientists and associates and drive technical excellence across the team.

Essential Duties and Responsibilities:

• Provide technical leadership and scientific direction for process development activities.

• Lead the development efforts to optimize PD capability. This involves designing experiments, analyzing data, and making recommendations for improvements.

• Analyze and interpret data to drive informed scientific decisions and process improvements

• Serve as a technical MSAT lead, evaluating process scalability, robustness, and tech-transfer readiness

• Support seamless transfer of processes from PD to GMP through technical documentation, training, and on-the-floor support

• Act as a subject matter expert (SME) for upstream processes and provide input on DSP from an MSAT perspective

• Mentor and guide scientists and associates on experimental design, execution, and troubleshooting (without formal reporting responsibility)

• Collaborate cross-functionally with Manufacturing, QA, QC, Program Management, and Business Development to ensure alignment and execution

• Support investigations and troubleshooting activities to identify root causes and implement solutions

• Prepare and present clear, data-driven scientific updates to internal stakeholders and clients

• Interface with clients to provide technical insight, updates, and support program needs

• Author and review technical documents including SOPs, batch records, development reports, and transfer protocols

• Evaluate and implement new technologies to enhance upstream and MSAT capabilities

• Maintain a strong presence in lab and GMP areas to support execution and continuous improvement

• Stay current with industry trends and advancements in plasmid DNA development and MSAT

• Support additional business and operational needs as required to ensure continuity, execution, and organizational objectives are met.

Expectations from the Role:

• Solution-oriented: Thinks and comes with answers, not just problems

• Resourceful: Can navigate constraints, prioritize, and mobilize support

• Clear in ownership: Knows their scope but also sees the bigger picture

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 45 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.

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.