Senior Scientist, Viral Vector Process Development
Process and Product Development | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
We are seeking a highly motivated, self-driven and collaborative downstream process engineer to join the Process and Product Development organization. The successful candidate will be a hands-on technical leader and work within a technical team focused on developing and advancing allogeneic cell therapies into clinical and commercial products.
In particular, this individual will engage with our external and internal partners to ensure robust and efficient viral vector manufacturing through process characterization, monitoring and technical support of external CDMOs. In addition, the successful candidate will help in advancing unit operation technology development, process scale up and parameter optimization. This position will be responsible for communicating with internal and external collaborators and will work in cross-functional teams supporting pre-clinical and clinical programs.
Responsibilities include, but are not limited to:
- Trouble-shoot upstream and downstream viral vector processes relying on strong experience of downstream unit operations such as filtration and chromatographic separation
- Support on-going activities with external collaborators and service providers
- Ensure effective information flow across internal and external partners and resolution and documentation of manufacturing issues
- Review/author process control strategy documents throughout product lifecycle
- Coordinate and ensure successful technical execution of pre-clinical, clinical and PPQ batches
- Oversee the monitoring and trending of process performance data
- Oversee root cause investigations for major production deviations and provide appropriate impact assessments and mitigation strategies
- Develop thorough understanding of manufacturing process to support successful launch of late-stage products.
- Build strong cross-functional partnerships with internal and external clients.
- Other duties as assigned
Position Requirements & Experience:
- PhD in engineering, biological sciences, or related discipline, with 2+ years of experience and proven record of related industry experience
- MS or BS in Chemical Engineering, Biochemistry or the related field with 8+ years of relevant experience in industrial cell culture process development
- Extensive experience and knowledge of upstream and/or downstream bioprocessing
- Strong organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Strong communication skills and ability to work independently as a leader.
- Proven ability to successfully work in a matrixed environment.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.
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.