Senior Associate Scientist / Principal Associate Scientist – Upstream Process Development

SUMMARY

Generation Bio seeks an enthusiastic and highly motivated Senior/Principal Associate Scientist to guide Drug Substance Upstream Process development as part of the Chemistry, Manufacturing and Control (CMC) department.  The Upstream Process Development team is focused on creating, optimizing and understanding the control strategy for our GMP compliant process. The successful candidate will have good laboratory skills and attention to detail to help develop and optimize enzyme-based production processes for DNA-based drug substance. This role will have high visibility in a company that is expanding to support a dynamic pipeline.

RESPONSIBILITIES:

Primary responsibilities for this role include:

• Design, execute and analyze process development and characterization experiments for enzyme-based production of DNA-based drug substance
• Document experimental execution and analysis via electronic lab notebook
• Establish scale-down process models and perform process characterization utilizing DOE principles
• Support development and optimization of RES ceDNA production and process methodologies for lead candidate and subsequent platform programs.
• Create and edit documentation including protocols, SOPS, batch records, reports.
• Identify and/or optimize unit operations to improve robustness, cycle time, throughput, and cost while maintaining product quality
• Support the development and optimization of the lead candidate through process innovation, and identification of key variables to improve process performance
• Prepare, analyze, and present data internally to cross functional teams

QUALIFICATIONS: 

• Degree in Molecular Biology, Bioengineering, Cell Biology or related discipline
• Minimum of 2 years of relevant industry experience
• Experience in developing processes for synthesizing biologics, enzymatic reactions, and/or purification of complex biomolecules
• Understanding and practical application of molecular biology techniques
• Sense of urgency, results-driven, and excellent attention to detail
• Proven ability to work independently, effectively plan work activities, and prioritize task completion to meet schedules and deadlines
• Strong collaboration and team-working skills

Desired experience:

• Knowledge of cGMP and regulatory guidelines and practices, and how these relate to and impact upstream development
• Track record of managing multiple projects and responsibilities simultaneously
• Experience with high throughput screening technologies and developing enzyme activity assays

POSITION: Full-Time, Non-Exempt