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Scientist or Engineer - Bioprocess Development

Department: Bioprocess
Location: Cambridge, MA
Scientist or Engineer - Bioprocess Development

 

What’s in it for you?

You will have the opportunity to accept the challenge associated with a new class of therapies, including the design, development, and demonstration of fermentation and purification operations for a wide variety of microorganisms.

You’ll establish yourself as a subject matter expert in upstream process development of anaerobic microbial strains commonly found in the human microbiome, with emphasis on translating small scale screening (medium development, high-throughput cultivation systems) into larger scales suitable for the development and demonstration of processes suitable for clinical manufacturing.

You will lead a small team to accomplish objectives related to the development of bioreactor cultivation methods, harvest and purification operations, scale-up to late-phase clinical manufacturing, and tech transfer to in-house and contract manufacturing organizations.  Your team will share responsibilities for pilot manufacturing of pre-clinical materials, and for material supply throughout the development organization from Analytical Development to Formulations.

While becoming a technical subject matter expert, you’ll also develop yourself into a project leader, with focus on overseeing and implementing conceptual scoping, process design, equipment selection, vendor interaction, technology transfer, and process demonstration with varying degrees of responsibility.  

We’re looking for team members that accept these challenges while being awesome coaches, mentors, and teammates for our current associates, engineers, and scientists with a real focus on building and supporting a learning organization and developing you into a leader by influence.

In the course of becoming all of the above, you’ll form really close partnerships within the bioprocess development team (analytical, formulations, and process development). You’ll also partner closely with Quality Assurance and Control, ensuring strict compliance with appropriate cGMPs. You’ll be interacting intimately with both manufacturing and discovery, and providing key input to the project teams, and when you’re ready, you’ll be a part of that product development team!

 

How do you know if you’re the right fit?

If you think you’re ready to build a company that is challenging some of the oldest paradigms in medicine, to contribute to a fast-paced environment encouraged by scientific challenges and regulatory hurdles, and to strive to help patients with a new form of medicine, then we want to hear from you.  To be successful you will have had relevant industrial bioprocess development experience with a focus on microbial systems.  You’ve kept complex projects on-scope, on-budget, and on-time, have demonstrated exceptionally clear communication, and you are comfortable in a dynamic environment which responds quickly to results to accomplish objectives.  A successful candidate will lead from the bench, embracing challenges with new technologies at the front-lines with their team. 

 

Qualifications

This is typically a role best suited for Ph.D. level candidates (or similar experience) in chemical engineering, bioprocess engineering, or equivalent, who have had direct reports in a fermentation development environment, preferably with experience stretching across multiple types of organisms.  Experience with various SCADA/batch management systems incorporating the use of online data acquisition for process control is expected.  Previous successful technology transfer experience is a plus, especially as it relates to modeling unit operations for scale up, and robust identification and assessment of process attributes. 

 

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