Principal Scientist, Bioreactor Process Design

Just – Evotec Biologics’ Bioreactor 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 and mammalian cell culture processes.  This person will join a fast-paced, collaborative, and multidisciplinary team to support bioreactor process development (perfusion and intensified fed-batch) at the bench and pilot scale for the advancement of low-cost biotherapeutics manufacturing.  This position will oversee bioreactor process development and will include clone screening, process optimization, technology transfer, and process characterization for continuous perfusion and intensified fed-batch processes as well as technology development to support end-to-end continuous bioprocessing. The successful candidate will be detail-oriented, self-motivated, and efficient in completing hands-on laboratory tasks, and experience with bioreactor equipment operation and maintenance, lab management, and organizing workspace and tasks are required.  The ideal candidate will have strong scientific group management and leadership skills as well as a proven track record of a deep understanding of mammalian cell culture and perfusion bioreactor development for the production of clinical and commercial therapeutic proteins. Strong written and verbal communication skills are required as well as experience in client and multi-site communication.  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.

Responsibilities

• Lead a diverse group of scientists responsible for development and tech transfer of early and late-stage (characterization and validation) upstreamperfusion/intensified fed-batchprocesses for biotherapeutics manufacturing as well as technology development projects. 

• Serve as a Project Team Lead to execute client projects that involve multiple functional areas and the full range of regulatory stages.

• Serve as an internal technical resource for cGMP manufacturing and Process Design as well as for external clients and partners for cell culture and bioreactor processes (small scale models, process transfer, and scale up) and author CMC regulatory sections.

• Collaborate across the organization to accelerate clinical development timelines while reducing development costs.

• Clearly and effectively communicate 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 design, execute, and analyze statistically designed experiments (DOE).

• Author SOPs, reports, and slides which summarize, organize, and interpret experiment results with review by appropriate team members. 

• Train, mentor, and supervise staff and interns.

• Potential for weekend work (5-day work week/ 2 days off) and being on-call for critical bioreactor runs.

Required Qualifications

• BS/MS in Engineering, Biochemistry, Biology, or related field with 12+ years of experience or Ph.D. in Engineering, Biochemistry, Biology, or related field with 8+ years of experience.

• Expertise in bioreactor cell culture and perfusion technology development and tech as well ass CMC sections authoring for regulatory filings.

• Experience with commercial process development, process characterization, and validation.

• Expertise in design of experiments (DOE) and statistical analysis.

• Experience with high throughput cell culture (e.g. HT assays, robotics such as Ambr systems, lab automation, or multi-omic data) is a plus.

Pluses

• Experience analyzing data in tools such as JMP, R, or Python.

• General understanding of cell biology, fluid dynamics, and biotransport as well as knowledge in other functional areas (downstream purification and analytical sciences).

• General understanding of circuits (grounding, power, signal, etc.).

• 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).

The base pay range for this position at commencement of employment is expected to be $140,000 to $170,000;  Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.