Director, Biologics Drug Product Development
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco, CA with additional office space in Brisbane, CA (10 miles south of San Francisco) and Basel Switzerland. This position will be located in Brisbane or Novato.
We are seeking a highly motivated and experienced technical leader to lead drug product development for Ultragenyx biologics products. This position will report to the VP of technical development and will interact with all levels across the company organizations. He/she will provide strategic direction, technical expertise, and tactical oversight for all activities in the area of biologics drug product development
Responsibilities, including but not limited to:
- Build and lead biologics drug product development group.
- Responsible for formulation development and drug product process development for Ultragenyx’s biologics products.
- Conduct tech transfer, scale up and drug product characterization activities.
- Support translational research programs as a technical consultant.
- Support manufacturing and quality in problem solving production issues and deviation investigations.
- Support CMC assessment of in-licensing opportunities and technology opportunities.
- Interact with global regulatory agencies and responsible for author and review of relevant sections of regulatory filings.
- A Ph.D. in pharmaceutical, chemical, biological sciences or engineering, with at least 10 years of biopharmaceutical experience, including 5 years in a leadership position
- Strong technical and leadership experience in drug product development, with general knowledge across disciplines affecting protein therapeutics
- Experience with liquid and lyophilized formulation development, aseptic processing, and drug product process transfer
- Proficient in quality and regulatory requirements of biologics products including ICH guidelines.
- Experienced in both early stage development and late stage/commercial development with strong record of successful IND/CTD/BLA/MAA.
- Experience leading CMC teams.
- Significant experience working in an outsourcing environment.
- Experienced in DOE statistical approach in process development. Experienced in process characterization and process validation.
- Excellent problem solving skills and verbal and written communication skills.
- Leadership and management experience of internal departments and contract manufacturing sites.
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.