Cell Line Development & Media Operations Director

Evotec

Toulouse, France

The Role: Your challenge …in our journey

We’re looking for a passionate and curious CLD & Media Operations Director to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a CLD & Media Operations Director at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

What You’ll Do:

Lead and grow a team including managers and Scientists in Molecular and cellular engineering as well as media support and media development to support all aspects of biologic cell line development from pre-clinical through late stage development;
Optimize strategies, and workflows that increase efficiency and de-risk projects;
Lead efforts to identify, evaluate and promote new cell line and media development technologies to support the mission of low cost biotherapeutics;
Collaborate across the organization and be a key member and contributor to the Process and Product Design Leadership Team;
Be a technical resource on CLD for novel biologics and biosimilars for Discovery, Process Design, Quality, and Manufacturing, as well as a resource and subject matter expert for clients, service providers and collaborators;
Serve as a CLD lead for complex projects and/or oversee leads on cross-functional project teams;
Manage and develop staff, and manage capital and resource planning;
Develop and refine CLD strategies that incorporate best practices and align with evolving regulatory expectations;
Support successful MCB and WCB manufacturing for client projects;
Ensure compliance with relevant ICH and pharmacopeia requirements;
Ensure compliance with EHS practices and the company's CSR policy;
Represent Just-Evotec Biologics at external meetings and conferences.

Who You Are:

An expert in cellular and molecular biology techniques to create stable cell lines suitable for protein therapeutics;
Experienced with expression construct design for cell lines expressing large molecules, such as mAbs, fusion proteins, and bi-specifics;
A strong expert in cell line development for protein therapeutics including experience with a multiple mammalian cell linesProficiency creating novel expression vectors to obtain highly productive cell lines that express material to meet process development product quality targets;
Experienced in cell line development for commercialization of novel biologics and biosimilars, including experience designing cell lines to match innovator PQA/CQA;
Gifted with a strong knowledge of regulatory guidelines and practices, and experience authoring IND/IMPD/BLA/MA sections;
Experienced utilizing high throughput automation and data systems;
Able to provide track record of scientific, management and leadership skills with the ability to work collaboratively and flexibly in a team environment with other functions to solve problems and deliver on projects;
Experienced with resource planning tools, capital planning and budgeting, and allocation and tracking of resources and equipment;
Gifted with an excellent written and verbal communication skills, with expertise communicating effectively over teleconference and web-based meetings;
A people-oriented and team player;
Your degree : Ph.D. preferred in a relevant field (e.g. biochemistry, chemistry, chemical engineering) or Master in Science;
Your experience: 15+ years (Ph.D.) or 20+ years (M.S.) of experience, or equivalent experience in the biotechnology or biopharmaceutical industry.