Engineer I/II

Generation Bio seeks an energetic and highly motivated Process Engineer I/II to join the Manufacturing, Science and Technology (MS&T) team and focus on ensuring a robust, scalable and efficient manufacturing process to produce LNP-based DNA gene therapy drug products for pre-clinical and clinical phase. Specifically, the person in this role will partner with Product & Process Research, Upstream Process Development, Downstream Process Development, Analytical Development, and Quality organizations to facilitate CMC advancement and success. 

The Process Engineer I/II will be responsible for the initial and subsequent CMC programs in process scale-up, documenting the process control strategy, tech transfer and close communication with related CMOs. The ideal candidate should have experience with bioreactors, column chromatography and TFF. The ideal candidate must be comfortable with early phase IND programs, working in a fast-paced environment, have GMP experience and familiar with using a risk-based approach to process characterization.

Primary Responsibilities Include:

• Support development and scale-up for our novel DNA platform using bioreactors, TFF and AKTA systems.
• Prepare buffers, columns and bioreactors needed for large scale/pilot plant work.
• Maintain necessary inventory levels of materials needed for large scale / pilot plant runs to support ongoing research.
• Document all work and submit samples to the AD group using the ELN system.
• Support technology transfer to a cGMP manufacturing suite for clinical trial material.
• Prepare, analyze, and present data internally to cross functional team to verify CQAs, KPPs and IPCs.
• Identify key vendors for raw materials and develop documentation (part number requests and specifications) for material quality and requirements.
• Work closely with the PD groups to establish key scale-related and manufacturing development strategies, including CQAs.
• Prepare and review process flow diagrams, development reports, SOPs and batch records.
• Identify opportunities to improve systems and practices, and drive harmonization across manufacturing platform.

Qualifications:

• Bachelors of Science with two plus years of experience or Masters of Science in Chemical Engineering, Bioengineering, Biochemistry, or equivalent with zero plus years of experience.
• Sense of urgency, results-driven, and excellent attention to detail
• Ability to drive decisions with internal stakeholders
• Ability to diversify technical skillsets in a fast-paced organization
• Ability to work with others to troubleshoot complex technical and scientific problems while showing independence in execution and thought processes

Desired experience:

• Prior work in a regulated environment (e.g. GMP manufacturing) desired
• Familiarity with enzyme driven bioproduction or nucleic acid production desired
• Proven ability to work independently, effectively plan work activities, and prioritize task completion to meet schedules and deadlines
• Prior work in a cross-functional, matrix-managed format were challenge to others and being challenged are expected