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Principal Scientist, Analytical Development (Tech Transfer)

Process and Product Development | South San Francisco, CA | Full Time

Job Description

Principal Scientist, Analytical Development (Tech Transfer)

Location: South San Francisco, CA


About Allogene Therapeutics, Inc:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Job Description

We are seeking a highly motivated Principal Scientist to join Allogene’s Process and Product Development organization to lead the analytical method transfer, You will support the transfer of analytical release methods to internal or CDMO partner. You will work with a multidisciplinary group of engineers and scientists to prepare the technology transfer package and provide onsite support at the CDMO as needed. You should be familiar with release methods performance and cGMP operations.

You must collaborate effectively with cross-functional teams including Process Development, Supply Chain and External Manufacturing to coordinate critical deliverables.

Responsibilities include, but are not limited to:

  • Draft method transfer packages and other technical documents including SOPs, test methods and transfer protocol in close collaboration with the CMC, QC and Process leads
  • Provide internal or onsite support at the CDMO, train new analysts, and oversee assay execution
  • Lead investigations to troubleshoot, execution challenges including RCA
  • Communicate effectively and work collaboratively with external manufacturing partners
  • Work with internal groups and CMDO to develop strategies to meet program timelines
  • Track CDMO technical performance and provide regular updates to program leaders
  • Develop workflows compatible with a cGMP environment
  • Scientific understanding and oversight of development and performance robustness of analytical methods for in-process, release and stability testing for a late stage biologics development program
  • Preparation and/or review of documents in support of CMC Regulatory BLA/ MAA filings and addressing queries from health authorities
  • Other duties as assigned

Position Requirements & Experience:

  • PhD in analytical sciences, biotechnology, pharmaceutical sciences, immunology, or equivalent life sciences field with 5 years of experience in late-stage analytical development for Cell therapy, MS 7+ years relevant experience, or bachelors with 10+ years of relevant experience
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines
  • Strong collaboration and interpersonal skills, including verbal and written communication, and ability influence
  • Proficient with relevant analytical methods including flow cytometry and cell-based assays
  • Ability to work independently and as part of a matrixed team
  • This position will require ability to travel to/ spend time at CDMO site(s)
  • Candidates must be authorized to work in the U.S.

 

As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

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