Senior Scientist, Upstream Process Development

Umoja Biopharma

Boulder, CO, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 06/02/2021
  • Website: www.umoja-biopharma.com
  • Company Address: 1920 Terry Ave, Seattle, WA, 98101

About Umoja Biopharma

Umoja is advancing an entirely new approach to immunotherapy designed to retool a patient’s immune system in vivo to provide broader access to the most advanced immunotherapies and enable more patients to live better, fuller lives.

Job Description

About the job

Umoja Biopharma is a game-changing biotech start-up in Seattle focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in a newly remodeled production process development lab in Boulder CO , and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development.  Umoja is looking to build a diverse employee-powered company with an inclusive culture.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families. 

 

Umoja Biopharma – Your Body. Your Hope. Your Cure. 

 

Position Overview  

 

Umoja is looking for a strong upstream process development scientist to lead activities for Umoja’s VivoVec (lentivirus) pipelines. Thorough knowledge of multiple areas of upstream, including suspension-based cell-culture, media development, transient transfection, process characterization, tech transfer, supporting analytical method development, as well as experience authoring CMC regulatory submissions is required. The ideal candidate will have a proven track record in upstream process development, CMC, tech transfer, and a demonstrated skillset/knowledge of process and product development. The position will be accountable for the upstream processes for VivoVec (lentivirus) pipeline, which spans from early research and development phases to commercial licensing. The incumbent will work directly with external and internal partners, including R&D, Program, MSAT, Analytical development, Quality, and manufacturing teams to support Umoja’s VivoVec pipeline and regulatory goals, including authoring of CMC sections of INDs and NDA/BLAs. Additionally, the role will support the establishment of new labs to support upstream process development and process characterization, and will work on a cross-functional team to deliver scalable, GMP compatible upstream manufacturing processes with corresponding IPCs, QC release strategies, and successful transfer to internal MSAT and manufacturing teams, as well as CMOs and CTLs.

This candidate will be a leader in the technical operations organizations and will play a critical role in advancing Umoja’s pipeline. The final level of this position will be based on the candidate’s qualifications.

 

Responsibilities:

  • Key contributor to the build out of the upstream process development lab
  • Key technical contributor to the successful design, execution, analysis, and documentation of upstream process development, strategy, and experimental plans for multiple DP candidates in the lentiviral pipeline
  • Technical lead for a scalable upstream manufacturing process per program timeline needs
  • Author, review, and/or approve technical documents including development reports, standard operating procedures, technical reports, and regulatory filings
  • Present findings on product characterization, process and method development to cross-functional teams
  • Participate in program and CMC teams to design and execute CMC activities to support lentiviral product development including participating IND submissions, including specification setting

 

Qualifications:

  • M.S. degree in biochemistry, pharmaceutical science, chemical engineering or related field with 5+ years of relevant experience or Ph.D. in relevant field with 3+ years of experience
  • Extensive experience with upstream process development and analytical assays, preferably for lenti or other enveloped viruses
  • Ability to work in a fast-paced environment with broad responsibilities, meet deadlines, and prioritize work on multiple projects
  • Experience developing CPPs and development plans corresponding in-process controls, product release testing paradigms, and process characterization and validation
  • Experience transferring processes to manufacturing/MSAT internally and externally
  • Significant experience with GxP, ICH, FDA regulations is required
  • Strong communication skills in technical writing and oral presentation. Respectful of others and open to new ideas

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.