Associate Director, Bioreactor Process Design

About the role

We're 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.

Responsibilities

• Leading a mammalian cell culture department with a diverse group of scientists encompassing all aspects of upstream process development, characterization, and validation as well as technology transfer to cGMP manufacturing for continuous processes.
• Leading highly complex projects and investigations by integrating deep knowledge of upstream process development and broad knowledge of project work with knowledge of multiple functional areas.
• Collaborating across the organization to accelerate clinical development timelines while reducing development costs.
• Driving technology development for process intensification and continuous manufacturing to reduce manufacturing costs and footprint through improvements in cell culture productivity, control of product quality, and data management while working with vendors and external partners as well as influencing the biologics industry.
• Serving as a Project Team Lead within the process development organization to execute on client projects that involve multiple functional areas and the full range of regulatory stages.
• 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 perfusion bioreactor processes (small scale models, process transfer, and scale up) and authoring CMC regulatory sections.
• Clearly and effectively communicating scientific information, experimental plans, and data to internal project teams, cross-functional area teams, senior management, external clients, vendors, and technology development collaborators as well as the external scientific community such as regulatory agencies, review boards, publications, and conferences.
• Managing staff, training, capital resources, and planning within the department while supporting multiple client projects at various stages of process development and characterization.
• Other tasks as assigned.

Requirements

• BS/MS in Engineering, Biochemistry, Biology, or related field with 15+ years of experience or Ph.D. in Engineering, Biochemistry, Biology, or related field with 9+ years of experience.
• Expertise in mammalian cell culture and perfusion bioreactor technology 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 upstream development teams for multiple external client projects and collaborations and internal technology development initiatives.
• Experience with high throughput cell culture (e.g. deep-well plate assays, robotic systems such as Ambr) as well as other functional areas (purification and analytical sciences) is a plus.

Qualifications

• Curiosity
• Resilient
• Creative mindset
• Teamplayer
• Forward-thinking
• Adaptable

Skills

• Strong scientific group management and leadership skills
• Proven track record of a deep understanding of upstream process development for clinical and commercial therapeutic proteins
• Strong written and verbal communication skills
• Experience in client and multi-site communication

Benefits

• Base pay range at commencement of employment: $154,000 to $180,000
• 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 $180,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value.

Schedule

N/A