Scientist I - Downstream Process Development

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

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 knowledge and experience in downstream processing, including chromatography, Tangential flow filtration, and formulation techniques. This role involves designing and executing experiments, analyzing data, writing reports, and collaborating with cross-functional teams to establish scalable and robust downstream processes that meet both client and regulatory requirements.

This position has the potential to be client-facing and 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, manufacturing science and technology, 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

 

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS or MS in biological engineering, chemical engineering, biology or other relevant degree

Essential

ON-THE-JOB EXPERIENCE

 

1-3 years of relevant industry experience

Desired

Solid foundation in the fundamentals of biochemical engineering, virology and cell biology

Essential

Entrepreneurial experience dealing with customers in product development

Desired

Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organi