
People on the Move: Alfred Chun joins Precigen as Director, Quality Systems and Compliance
Precigen appoints Alfred Chun as the Director, Quality Systems and Compliance where he will be responsible for preparing the site for regulatory inspection.
December 5, 2024
BioBuzz’s mission is simple: to be more connected. Our regionally-focused storytelling, programs, events and experiences connect, amplify and create impact across the life science workforce in growing biohubs. Submit your People On The Move (free and ongoing) to showcase your company’s growth by promoting your new hires and recent promotions. |
Precigen is a dedicated discovery and clinical-stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases.
About Alfred Chun
In his role at Precigen, Alfred Chun is responsible for overall compliance and preparing the site for regulatory inspection. This includes, managing inspections by the FDA and other regulatory bodies; ensuring compliance with all regulations, requirements and industry standards; contributing to the transition of Precigen’s Quality System to commercial readiness; managing Quality Systems; and assisting with writing, compiling, and reviewing IND/BLA and other regulatory filings.
Alfred has a proven track record of over 10 years of relentless commitment to compliance, operational excellence, and team development. With a background encompassing senior roles at Charles River Laboratories and Emergent BioSolutions, he has consistently driven forward-thinking strategies in Quality Control, Quality Management Systems and Regulatory Compliance. Throughout his tenure, he has orchestrated the development and implementation of robust QMSs aligned with global regulatory requirements. His expertise in leading high-performing teams to meet and exceed quality standards has been pivotal in ensuring seamless operations and strategic growth. Notably, his strategic oversight extends to managing CDMOs and overseeing comprehensive supplier/vendor qualification programs, where he leverages insights gained from his experience to mitigate risks and optimize supply chain operations effectively.
“Precigen is pleased to have Alfred join the QA team. His many years of experience in Quality Control, Quality Assurance, and Regulatory Compliance will be an invaluable asset as we prepare for FDA submission and potential commercialization of our lead adenovector-based therapy for the treatment of RRP (Recurrent Respiratory Papillomatosis).” states Andy Romano, Vice President and Head of Quality Assurance
About Precigen
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical-stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Their technologies enable them to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization.
- About the Author
- Latest Posts
BioBuzz is a community led, experience focused, biotech and life sciences media and events company. BioBuzz highlights regional breaking news, industry professionals, jobs, events, and resources for business and career growth. Their weekly newsletter is subscribed to by thousands in the BioHealth Capital Region and Greater Philadelphia as the go-to for industry updates.