Actalent Senior Process Development Scientist in Boston, Massachusetts
Drive the development / optimization of E. Coli expressed recombinant protein manufacturing from downstream fermentation to upstream purification to support upcoming Clinical Trial
Design methodical and detailed experiments to develop and optimize recombinant protein manufacturing process, with risk / benefit assessed at each step
Oversee manufacturing of clinical material
Lead the evaluation of any issues related to manufacturing deviations, non-conformances, root cause analysis, CAPA implementation, and GMP compliant Change Control documentation
Interact directly with CRO/CMO and increase the communication
Interpret data from the last two years to present findings
GMP manufacturing experience
Draft, review, and/or approve quality related documentation, which includes raw material specifications, component specifications, batch records, deviation reports, Change Control documentation, validation protocols/reports and CAPA plans
Create and present slide decks with data reports and create plans to CEO, CSO, Quality, internal and external stakeholders
Set and participate in meetings weekly with internal and external partners
Organize data, explain reasoning behind responses to data sets
Involved in designing validation strategies as part of the team
Reviewing, writing procedures,
Lead in investigating deviations, assessing impact, resolving deviations
Additional Skills & Qualifications:
Minimum Master’s degree in science field preferred
Minimum 5+ years’ experience in E. Coli expressed recombinant protein process development and optimization.
Minimum 2+ years’ experience in GMP manufacturing of E. Coli expressed recombinant protein.
Strong understanding of GMP requirements and FDA regulations.
Superior organizational skills.
Strong written and oral communication skills.
Strong problem solving abilities, critical thinking, with the ability to move team discussions forward into executable actions items.
Attention to detail and ability to fully comply with Quality System documentation requirements
May need to use team communication platforms such as slack and google meets
Diversity, Equity & Inclusion
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Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
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