Process Development Scientist / Engineer (viral vectors)
Process Development Scientist / Engineer (viral vectors)
Location: Bay Area, California
About Us: Azalea Therapeutics is an early-stage biotech startup on a mission to revolutionize genomic medicines. By designing vehicles that enable cell-specific delivery inside the body, the company aims to unlock precision therapeutics for genetic diseases and unleash the promise of cellular-based therapies.
Position Summary:
We are seeking a highly motivated and experienced Process Development Scientist / Engineer to join our dynamic team for a lab based position. The ideal candidate will have a strong background in process development and analytics for cell and gene therapies (e.g. exosomes, virus-like particles, lentivirus, retrovirus, and/or AAV) and possess exceptional leadership and technical skills.The successful candidate will join a team of scientists in the development and optimization of upstream and downstream processes for vector production and characterization.
Responsibilities:
- Scale from research methods to bench scale production methods for viral vectors to improve manufacturing efficiency, yield, and quality.
- Develop and optimize downstream purification processes, including chromatography, filtration, and concentration.
- Develop standardized analytical methods for process characterization and quality control.
- Investigate and troubleshoot process issues to identify root causes and implement corrective actions.
- Support the generation of material for pre-clinical in vivo studies
- Collaborate with cross-functional teams to ensure alignment and effective communication. Support team members to foster a positive and productive work environment.
- Manage project timelines, resources, and deliverables to ensure successful completion of objectives.
- Coordinate and collaborate with external CDMOs to ensure consistency and efficiency in process development and implementation.
- Develop and implement standardized protocols and procedures to maintain quality and compliance.
Qualifications:
- Minimum of Bachelors in a relevant scientific discipline (Biology, virology, biotechnology, chemistry, etc)
- Minimum of 3-5 years of experience in vector manufacturing, with a strong focus on upstream and/or downstream process development.
- Demonstrated expertise in lab scale vectors/biologics production using mammalian cell transient transfection methods.
- Excellent problem-solving, analytical, and organizational skills.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
Preferred Qualifications:
- Viral vector or exosome upstream and downstream process development experience.
- Strong understanding of cGMP manufacturing and regulatory compliance.
- Familiarity with quality management systems and regulatory requirements.
- Over 5 years of cell and gene therapy process development is a plus.
- Adaptable and capable of managing junior scientists/engineers
If you are a passionate and talented scientist/engineer looking to make a significant impact in the field of in vivo delivery, we encourage you to apply.