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 GENEZENMany 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 SUMMARYThe 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 EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBS, MS, or PhD in biological engineeringDesiredON-THE-JOB EXPERIENCE4-5 years of relevant industry experienceDesiredSolid foundation in the fundamentals of biochemical engineering, virology and cell biologyEssentialEntrepreneurial experience dealing with customers in product developmentDesiredPharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing OrganizationsDesiredExperience with cell culture technologies, molecular biology, upstream processing, and aseptic processingDesiredSKILLS / ABILITIESWorking knowledge Downstream process and AKTA chromatography and tangential flow filtration.DesiredAbility to interface successfully with multi-disciplined teamsDesiredExtremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand toolsDesiredPHYSICAL 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
GENEZEN'S CURES VALUE-BASED COMPETENCIESCommitted to ScienceWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.Urgency in action for the patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.Resilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principals.Solutions driven for our partnersWe are committed to being a proactive, collaborative, creative and open-minded partner.GENEZEN'S BENEFITS
- Paid vacation days, amount based on tenure
- Paid sick time
- 9 observed holidays + 1 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
- Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.