Director of Downstream & Purification - Process Sciences

Evotec

Toulouse, France

Just-Evotec Biologics is looking for a Director of Process Sciences to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of Purification & Dowstream process for the advancement of low-cost biotherapeutics manufacturing through the refinement and implementation of integrated, continuous bioprocessing. This position will oversee purification development for both early and late stage processes including process development, optimization, characterization and technology transfer to manufacturing. The position requires strong management and leadership skills as well as a deep understanding of biologics process development. Experience developing new technologies including development and operationalizing continuous manufacturing capabilities is preferred.  A proven track record of technical skills in this area, as well as experience leading groups of scientists is required.  Strong written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are necessary. 

Responsibilities:

Lead a diverse group encompassing all aspects of large molecule process sciences;
Optimize strategies for process development for downstream purification processes;
Define, monitor and improve early phase, commercial processes and process characterization activities;
Drive technology development for process intensification and continuous manufacturing to reduce manufacturing costs and footprint;
Be a technical resource on cross functional teams for high throughput and bench scale chromatography, various forms of filtration, small scale model qualification and viral clearance, process transfer and scale up, and authoring CMC regulatory sections;
Collaborate across the organization and be a key member and contributor to the Process and Product Design Leadership Team;
Manage staff and capital resources and planning;
Develop and refine regulatory communication both written and face-to-face;
Be a technical resource for P&PD, Manufacturing, Quality and Regulatory as well as for clients and process development teams.

Basic Qualifications:

Master or Ph.D preferred in a relevant field (e.g. biochemistry, molecular biology, chemical engineering) with 15+ years of experience.

Preferred Qualifications:

15+ years relevant experience in academia and biopharmaceutical industry;
Experience with regulatory filings including IND/INDa/BLA;
Experience leading purification process development teams;
Experience with high throughput resin screening, automation and data systems;
Expertise in purification process development and transfer to manufacturing plants, and authoring CMC sections of regulatory filings. Experience with connected, continuous manufacturing is a plus;
Experience with commercial process development, process characterization, and validation;
Expertise in design of experiments (DOE) and statistical analysis;
Experience leading purification process development teams;
Motivated, self-starter with strong leadership skills;
Customer orientated;
Ability to lead a team;
Good interpersonal, team, and communication skills are a must;
Excellent oral and written communication skills;
Experience with capacity planning tools and allocation of resources and equipment;
Fluency in French though not required is highly preferable.