Senior Scientist, Gene Editing Materials Process Development

Role Description

We are seeking a highly motivated, self-driven and collaborative individual to join the Process and Product Development organization. The successful candidate will serve as a technical lead working with internal teams and external CDMOs focused on development and continued improvement of the manufacturing processes of gene delivery and/or gene editing materials used in allogeneic cell therapies. This individual will provide technical leadership across the product lifecycle, from early-stage process development through late-stage process characterization, control strategy development and commercial manufacturing readiness to support BLA submission and commercialization. This position will also provide technical oversight to support the production and re-supply of gene delivery and gene editing materials, as appropriate. This position can be remote with some travel to San Francisco and various CDMO sites.

• 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

Qualifications

• 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
• 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

Requirements

• This is a 1-year contract opportunity with the possibility of extension or contract-to-hire

Benefits

• 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

Company Description

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.