Sr. Scientist, Gene Editing Materials Process Development(temp)

include, but are not limited to:

• Serve as technical subject matter expertise supporting CDMOs to provide process development expertise for gene editing and/or gene delivery materials
• Partner with internal and external R&D, External Manufacturing, MSAT, and Quality to ensure cross-functional alignment
• Contribute to process development, process characterization, control strategy development and PPQ planning activities
• Work with internal and external partners to assess impact to process and method change for gene editing and/or gene delivery materials
• Support planning, execution and troubleshooting deviations of Process Development and GMP runs at CDMOs
• Assess impact of gene editing and/or gene delivery materials on CART production process
• Engage with broader Process and Product Development team to contribute to achievement of Department goals
• Other duties as assigned

• PhD in biological sciences, engineering or related discipline with 5+ years of relevant experience in process development for the manufacturing of gene and cell therapy or related field is required (or MS with 10+ years, BS with 12+ years of industry experience)
• Strong knowledge background and direct experience developing, characterizing, scaling, or supporting GMP manufacturing processes for gene editing materials (e.g., mRNA, nucleases) and/or gene delivery materials (e.g., AAV, lentiviral vectors, non-viral delivery systems) is strongly preferred.

solely using these materials for gene editing applications without involvement in process development or manufacturing is unlikely to meet the requirements of this role.

• Experience with applying Design of Experiments (DOE), statistical analysis, and data visualization tools (JMP, Spotfire, or equivalent) for process development or characterization studies
• Prior experience serving as technical support for internal and external teams to manage process development and manufacturing at CDMOs is a plus
• Experience with analytical assay development, qualification, transfer is a plus
• Familiarity with cGMP manufacturing and regulatory expectations for biologics gene editing material or cell therapy products is a plus
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
• Ability to work independently and in a matrixed environment
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Ability to travel up to 10%
• Candidates must be authorized to work in the U.S
• This is a 1-year contract opportunity with the possibility of extension or contract-to-hire.

We offer a chance to work with talented people in a collaborative environment.

The expected hourly range for this role is $60 to $70 per hour.

Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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