Lead Scientist, Upstream Process Development & MSAT

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 MSATSupport 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…