Lead Scientist II, Process Development, pDNA

Company

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products. It became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group.

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.

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

Benefits

• 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.
• Retail 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.