Scientist II/III - Downstream Process Development - Genezen

JOB SUMMARY

The Downstream Process Development Scientist will be responsible for developing and optimizing purification processes for Adeno-associated viruses (AAV), Lentiviral vectors (LVV) and Retroviral Vectors (RVV) at Genezen Lexington, MA facility. The ideal candidate will have extensive experience in downstream processing, including chromatography, Tangential flow filtration, and formulation techniques. This role involves designing and executing experiments, analyzing data, and collaborating with cross-functional teams to establish scalable and robust downstream processes that meet both client and regulatory requirements.

This is a client-facing position that demands constant interaction and adherence to strict timelines. The individual must collaborate with cross-functional teams to establish and implement the best regulatory and laboratory practices and lead the execution of complex experiments.

ESSENTIAL JOB FUNCTIONS

• Develop and optimize downstream processes for AAV purification, including clarification, chromatography, filtration, and formulation.
• Scale-up processes from bench-scale to pilot and production scales up to 2000L, ensuring consistency and efficiency
• Responsible for monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality
• Develop and support process optimization efforts to increase process robustness, reduce costs, and improve viral yield and purity
• Conduct process characterization studies to identify and control critical process parameters.
• Support the commercial function in the assessment of new opportunities and provide appropriate technical input to prospective customers, including the demonstration of capability at customer visits
• Design and execute experiments independently: accurately record, analyze, and communicate data to senior management and team members
• Maintain open communication via one-on-one and team meetings
• Stay current with relevant technologies and needs to be adept at identifying new approaches
• Perform and lead single-use system design, selection, implementation, and control strategies
• Collaborate closely with upstream processing, analytical development, quality control, and quality assurance teams to ensure integrated process development and transfer.
• Maintain external technical relationships and collaborate with equipment and material suppliers
• Stay current with advancements in downstream processing technologies and methodologies.
• Propose and implement innovative solutions to enhance process efficiency, product purity, and yield.
• Serve as process SME for regulatory and client audits
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

•  Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail