Lead Scientist II, Process Development, pDNA

Celgard•The Woodlands, TX

64d•Hybrid

About The Position

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.

Requirements

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.
Strong attention to detail.
Effective verbal and written communication skills.

Nice To Haves

Proven client interactions and project management experience desired.

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.