Senior Manager, Purification Process Development

Senior Manager, Purification Process Development

Evotec

Toulouse, France

General Summary:

Just – Evotec Biologics’ Purification Process Development group is seeking an enthusiastic and hardworking team member who is passionate about expanding worldwide access to biotherapeutics through the advancement of continuous bioprocessing technology. This person will join a fast-paced, collaborative, and multidisciplinary team to support purification process development at the bench and pilot scale for the advancement of low-cost biotherapeutics manufacturing. Process design at Just-Evotec means exposure to innovative technologies like high throughput automated robotic screening and continuous processing technologies for a first-of-its-kind flexible and reconfigurable manufacturing facility. The successful candidate will have experience in chromatography and filtration theory and operations. Experience with high throughput chromatography screening, chromatography mechanistic modeling, multicolumn chromatography and/or process modeling is a plus. The ideal candidate will have strong scientific group management and leadership skills as well as proven track record of a deep understanding of purification process development for Biosimilars. Strong written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are necessary.  Experience with common software packages (such as Microsoft Office, Google Suite, etc.) is required. Finally, the ideal candidate is curious, creative, engaged, and the type who works well independently and in teams while constantly looking for ways to advance scientific processes and improve technology.

Missions and responsibilities:

• Leading a diverse group of scientists encompassing all aspects of purification process development, characterization, and validation as well as technology transfer to cGMP manufacturing for hybrid and continuous processes;
• Serving as an internal technical resource for cGMP manufacturing and Process Design as well as a resource and subject matter expert for external clients and partners for cell culture and bioreactor processes (small scale models, process transfer, and scale up) and authoring CMC regulatory sections;
• Collaborating across the organization to accelerate clinical development timelines while reducing development costs;
• Clearly and effectively communicating scientific information, experimental plans, and data to internal project teams, senior management, external clients, vendors, and technology development collaborators as well as the external scientific community such as regulatory agencies, review boards, and conferences;
• Independently designing, executing, and analyzing statistically designed experiments (DOE);
• Authoring SOPs, reports, and slides which summarize, organize, and interpret experiment results with review by appropriate team members;
• Working with vendors and manufacturers in developing, ordering, and troubleshooting equipment prototypes;
• Training, mentoring, and supervising staff and interns;
• Driving technology development for process intensification and continuous manufacturing to reduce manufacturing costs and footprint through improvements in culture productivity, control of product quality, and data management;
• Supporting the management of staff, capital resources, and planning within the department.

Knowledge, skills and abilities:

• Expertise in purification technology and process development, transfer to cGMP manufacturing plants, and authoring CMC sections of regulatory filings;
• Experience in Biosimilar development;
• Experience with commercial process development, process characterization, and validation;
• Expertise in design of experiments (DOE) and statistical analysis;
• Experience in training, mentoring, and supervising team members as well as leading development teams for external client projects and collaborations and internal technology development initiatives;
• Experience with high throughput process development systems is a plus.

Pluses

• Experience analyzing data in tools such as JMP, R, or Python;
• General understanding of cell biology, fluid dynamics, mechanistic modeling for chromatography, and protein chemistry as well as knowledge in other functional areas (upstream and analytical sciences);
• Experience working in a cGMP or clean room setting (this job is non-GMP but knowledge of GMP is helpful for process/tech transfer activities).

Experience and education:

• Master’s degree in engineering, Biochemistry, Biotechnology or related field with 12+ years of experience or PhD with 10+ years of experience;
• Proficiency in both verbal and written English is essential.

Other information:

• Availability to work occasionally on weekends and evenings is required.