Upstream Process Developer

Company: Orum Therapeutics
Location: Cambridge
Posted on: May 13, 2022

Job Description:

Orum Therapeutics is seeking to expand our in-house process development capabilities to help advance quality compounds toward the clinic. The successful candidate will provide technical leadership, management and oversite for process development and manufacturing performed at contract organizations. The candidate will also collaborate with multiple stakeholders including Quality Control, Quality Assurance, Research, Analytical Development, Chemistry and Biology.

Principle Duties and Responsibilities
--- Manage development of stable cell-lines and cell banks for GMP manufacturing
--- Manage development and optimization of robust upstream manufacturing processes
--- Oversee tech transfer, scale-up and manufacture of biologics to support nonclinical and clinical studies
--- Utilize advanced statistical techniques such as DOE to optimize early and late-stage processes
--- Prepare CMC documentation for regulatory filings
--- Establish and maintain an understanding of current trends and upstream process development technologies
--- Participate in CMC due diligence activities
--- Provide clear communication to relevant teams regarding progress against technical objectives and milestones
--- Ensure well-organized, clear, and complete documentation of all activities across areas of responsibility

Skills, Abilities & Competencies
--- Hands-on experience in upstream process development required
--- Experience in clinical-phase and/or commercial cGMP biologics regulations; working knowledge of product development and clinical manufacturing requirements
--- Experience managing vendors/external labs preferred
--- Knowledge with the use and interpretation of guidance including ICH, USP/NF, EP.
--- Strong organizational and time management skills. Ability to organize and prioritize to meet deadlines in an unknown environment with competing priorities
--- Excellent oral and written communication skills and proven ability to work autonomously and manage effectively in a matrix environment
--- A track record of innovation and scientific rigor, strong problem solving and troubleshooting skills, and ability to contribute constructively to discussions

Education - Ph.D. in Chemical Engineering, biochemistry or closely related field with 3+ years, MS with 6+ years or BS with 8+ years of relevant experience

Orum offers a Core benefits program which includes: medical, dental, short and long term disability, life insurance and a 401k.

*U.S. citizens and those authorized to work in the U.S. (green card) are encouraged to apply. We are unable to sponsor at this time.
*Candidate must be able to pass a background investigation.
*Only local residents to the Boston area will be considered.
*Unable to work with 3rd party candidates or agencies.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Orum Therapeutics is an Equal Opportunity Employer (EOE).

Keywords: Orum Therapeutics, Cambridge , Upstream Process Developer, IT / Software / Systems , Cambridge, Massachusetts