Senior Scientist, Downstream Process Development

Senior Scientist, Downstream Process Development

Cambridge, MA

Our client is a pre-clinical, VC-backed biotechnology company that is leveraging naturally derived extracellular vesicles (EVs) to deliver gene therapies in vivo. They are operating on a hybrid-virtual model. Meetings are mostly virtual, but teams will meet in person to whiteboard strategy, visit partners to advance programs, and celebrate wins!

THE PERSON AND ROLE

The Process Development Scientist position is full-time and will be 100% in-person designing and conducting experiments. You will work directly with the CMC leadership at the client and its CDMO partner to manage process development, optimization, process scale-up, and preclinical manufacturing. This is a critical development position that enables working in cross-functional teams, learning and developing all aspects of manufacturing process (upstream, downstream, and analytics) and provides significant career growth opportunities.

To be successful in this role, you should be someone who is self-starter, always up or a challenge and finds the unique demands of the fast-paced startup environment motivating. You will need to be adept at managing both internal projects and external collaborations, and be able to do both while espousing the people-first, simplicity-oriented values we hold as core to culture.

KEY RESPONSIBILITIES

• Design, execute, and analyze experiments to help develop a scalable manufacturing process and establish process parameters for Extracellular Vesicle (EV) production to support research and preclinical programs
• This opportunity will be in both cell culture and purification process development. Hands-on experience in at least one of cell culture or purification process development is preferred
• Develop, optimize, and scale-up a cell culture process for the production of EVs
• Develop, optimize, and scale-up Tangential Flow Filtration (TFF) for isolation and concentration of EVs
• Develop, optimize, and scale-up a purification process of high quality EVs
• Identify and implement relevant in-process analytics to gain more thorough process understanding.
• Work effectively with CDMO partner to design experiments, review data, and make scientific recommendations
• Author and review batch records, technical reports, and supporting procedures.
• Work closely with team members (internal and external) to maintain project development, implementation and troubleshooting of experiments, and ensure deliverables for both internal research projects and external scientific partnerships
• Attend and present at team meetings to share results, and plan projects and experiments, with a keen eye for achieving company milestones
• Perform other duties as assigned, including all those associated with facilitating the smooth operation in the lab.

QUALIFICATIONS & EXPERIENCE

Required:

• Ph.D. in Biological Sciences, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or Biomedical Engineering, MS degree in life sciences with 3 years of related industry experience, or BS degree in life sciences with 5 years of related industry experience.
• Ability to balance/prioritize research efforts across multiple programs, meet deadlines, and shift plans in service of a rapidly changing startup environment
• Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors.
• Action oriented, results driven, and able to accomplish project objectives and meet or exceed expectations.
• Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
• Proficiency with Microsoft Office suite, with excellent PowerPoint and Excel skills
• Exceptional communication, writing, organizational and time management skills
• Exemplary lab notebook practices, and attention to detail in recordkeeping

Preferred:

• Knowledge and experience in developing and scaling up cell culture, isolation and concentration of biologics, and purification of biologics or gene therapy products are highly preferred
• Understanding of gene therapy vector characteristics and critical attributes so as to direct bioprocess development and product/process control strategies
• Experience in hematopoietic stem cell biology and hematologic diseases
• Experience working with collaborators and CDMOs
• Experience with electronic lab notebooks (ELNs)

KEY POSITION DETAILS

• Full-time Position
• Salary and benefits consistent with the competitive market of Boston/Cambridge and commensurate with experience
• In-person benchwork in Boston/Cambridge area and/or at partner headquarters location(s)
• Current U.S. work authorization required

SDL2017