Process Development Scientist / Engineer (viral vectors) - Azalea Therapeutics, Inc.

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.