Associate Director, Cell Line Development
Why Join Us?
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 individual to manage cell line development, cell banking, plasmid DNA manufacturing, and cell culture process optimization for Ultragenyx biologics products. This position will report to the Director of Cell Culture Process Development in Technical Development group. Management of CMOs and CROs is a critical aspect of the job. He/she will also be involved in setting up internal development lab and hands-on activities in upstream technology development.
Responsibilities, including but not limited to:
- Responsible for cell line development, cell bank manufacturing and characterization
- Manage and support plasmid DNA manufacturing for mRNA therapeutics.
- Introduce, develop, and implement new strategies/technologies to enable accelerated CMC development
- Design and build internal upstream development lab
- Support cell culture process development, tech transfer, and cGMP manufacturing at CRO/ CMOs.
- Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CMO/CRO.
- Collaborate with downstream, quality control, quality assurance and translational research on development projects.
- Interact with global regulatory and provide support for relevant sections of regulatory filings
- PhD in Cell Biology/Molecular Biology / Chemical Engineering /Biochemistry, with 8+ years of biological process development and manufacturing experience with a strong record of achievement.
- Hands-on experience in cell line development; familiar with regulatory guidelines related to MCB/WCB manufacturing and release
- Experience in managing CMOs and CROs.
- Experience in plasmid DNA manufacturing process development is a plus
- Experience in cell culture process optimization using DOE approach is a plus.
- Knowledge of CMC regulatory requirements for biological pharmaceutical products at both early and late stages of development
- Excellent problem solving skills and verbal and written communication skills.
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.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: email@example.com.