Manager, Upstream Process Development, Plasmid DNA

Asahi Kasei•The Woodlands, TX

35d

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. 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.

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

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.