Principal Scientist, Purification Process Design

About the role

The Role:

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.

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. Strong written and verbal communication skills are required as well as experience in client and multi-site communication.

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 purification processes (small scale models, process transfer, and scale up) and authoring CMC regulatory sections.
• Serving as a functional area lead for platform or complex client early-stage (FIH) and late-stage Process Characterization (PC) projects as well as technology development projects.
• 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.

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 purification technology and process development, transfer to cGMP manufacturing plants, and authoring CMC sections of regulatory filings.
• 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

Skills

• Strong scientific group management and leadership skills.
• Proven track record of a deep understanding of purification process development.
• Strong written and verbal communication skills.
• Experience in client and multi-site communication.
• Experience with high throughput process development systems is a plus.

Benefits

• Base pay range for this position at commencement of employment is expected to be $154,000 to $174,000; 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, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Pay

The base pay range for this position at commencement of employment is expected to be $154,000 to $174,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value.

Schedule

Not specified