Head of Process Development

We are seeking a Head of Process Development to develop exceptional upstream mammalian bioprocess platforms for diverse therapeutic modalities. You will be an in-lab leader for a growing team that is responsible for designing, executing, and optimizing cell culture processes using AMBR and benchtop bioreactors, with the goal of developing scalable and robust processes that can be tech transferred to our partners for the production of biologics, AAV, and Lentiviral vectors.

Working closely with the Synthetic Biology, Cell Line Development and Modeling and Simulation teams, you will leverage Asimov’s unique in silico genetic design and process predictive technologies to advance the state of the art in manufacturing of next-generation therapeutics. You will also interface with our external partners to ensure effective technology transfer and proactive regulatory compliance. This role reports directly to the VP of Cell Technologies and is a unique opportunity to work at a nimble, forward-thinking synthetic biology startup to help build the future of biological engineering.

About the Role:

• Act as the lead subject matter expert for CHO and HEK biotherapeutic upstream process development, integrating bioprocess modeling, quality by design, and technical transfer at Asimov.
• As a people manager, hire new team members and direct the efforts of our existing team of scientists and engineers in their upstream process development activities for biologics and viral vector production.
• Guide individuals and the team towards personal and professional development milestones, all in support of Asimov's vision and goals.
• Employ hypothesis-driven rational experimental and process design with a solid statistical basis, enabled by Asimov’s process data pipeline. 
• Advance Asimov’s maturity in process quality, process data collection, and data-driven process development.
• Collaborate with the Modeling and Simulation team to develop in silico predictive models of cell culture performance using multi-omics analysis and apply them to process optimization.
• Author, review, and approve study plans, process development reports, and technology transfer protocols.
• Drive technology development efforts within the team based on industry best practices and emerging trends, including the addition of downstream process development capabilities, the development of proprietary cell culture media, new cell culture operating modalities, and integration of data science and modeling solutions into process development workflows.
• You’ll attend and present at industry conferences, contribute to industry forums such as AMBIC and BioPhorum, support patent applications, and write manuscripts for publication.
• This is primarily an on-site role, requiring you to be on-site an average of 4 days a week. Our team works from our brand new lab and office in the Fenway neighborhood of Boston, MA.

About You:

• You have a passion for optimal design of experiments, statistical analysis, and data-driven, rational process design.
• CHO-based biologic or HEK293-based viral vector process development is squarely in your wheelhouse, stemming from years of experience scaling-up an upstream mammalian cell culture process from benchtop to pilot or production-scale manufacturing. 
• You have a history of success managing scientists performing biologics or viral vector upstream process development. 
• You have experience developing processes for a quality- or regulatory-focused environment, e.g in accordance with GMP manufacturing principles or ISO9001 or equivalent quality management system.
• You have a Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field.
• We’re looking for someone with 5+ years of management and 10+ years of upstream process development experience at a biopharma company or CDMO.
• Don’t let this stop you from applying, but it’s a plus if you are familiar with downstream process development.
• Experience working with a global customer base isn’t a requirement for this role but bonus points if you have it.
• Being detail-oriented isn’t just a sound bite for you, it’s part of your DNA. Keeping track of a bunch of moving parts is easy for you because you’re highly organized.