3 weeks ago

Principal Engineer, Upstream Process Development

waltham Competitive Permanent

Job Reference: PDE_1621509259

Our client, a fully integrated biopharmaceutical leader, focus on developing innovative medicines that make a meaningful difference to people living with addiction, mental illnesses, and cancer. They are looking to hire a talented Director or Associate Director into their biologics upstream process development team.

This company has multiple sites across the US and Europe, with the shared goal of pursuing great science with deep compassion, striving to make a real impact on the lives of patients, families, and communities.

The position will suit someone who can bring a solid background in biological engineering with a focus on bioreactor engineering, scale-up and technology transfer. The ideal candidate will have several years of experience working with mammalian processes in glass bioreactors as well as single-use technology.

We are looking for a senior candidate who can see themselves either taking on management responsibility or progressing into a Subject Matter Expert for the department without people management. We are hoping to find a candidate with strong communication and interpersonal skills, and a commitment to continuous learning.

Responsibilities:

* Develop robust biological process platforms, enabling successful transition of assets from Discovery Biology into Process Development and provide in-depth expertise in all upstream related activities

* Day-to-day execution of bioreactor experiments at various scales (AMBR-15, 2 L SUB, 10 L glass, 50 L SUB)

* Develop fed-batch processes and feed strategies

* Technical oversight of upstream development activities at CDMOs

* Implement scale-up strategies for bioreactor operations internally and at CDMOs with a focus on process understanding, identification of critical process parameters, and process optimization

* Function as internal lead for Upstream Process Characterization

* Collaborate within cross-functional teams, including Discovery Biology, Analytical Development, Quality Assurance, Technical Operations and Validation

* Write technical reports and deliver presentations to technical, CMC and broader project groups

* Author & review CMC sections of regulatory filing documents (previous experience of doing this is not essential)

Minimum Experience:

* PhD in Biological or Chemical Engineering (or another relevant discipline) with at least 6 years' relevant experience working in the industry

* MS in Biological or Chemical Engineering (or another relevant discipline) with at least 12 years' relevant experience working in the industry

* Experience with stirred tank bioreactors for mammalian culture processes is a must

* Hands-on experience in designing, optimizing, and executing novel bioprocesses in pilot labs or commercial plants

* Process Characterization experience would be preferred, but is not essential

* Team player with excellent interpersonal skills

* Prior managerial experience would be a plus


Please don't hesitate to contact us or apply to this advert to arrange a discussion, or contact Ali Bagheri at abagheri@pararecruit.com. We are excited to hear from you!


Keywords: Biologics, Process Development, Mammalian, Bioreactor, AMBR, GMP, Pharmaceutical, Manufacturing, Process Characterization


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