Director, Manufacturing Management

Ultragenyx Pharmaceutical - Novato, CA (30+ days ago)4.4


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, and we also have an office in Brisbane, CA, 10 miles south of San Francisco. This position can be located in Novato or Brisbane.

Position Summary

We are seeking a highly motivated and experienced Biotech leader to support CMC development and manufacturing for Ultragenyx’s small molecule products. Ultragenyx currently has small molecule projects at the pre-clinical and clinical phases of development. The role will require leadership skills that could include CMC lead, CMO relationship, and team member of various projects in the CMC area. Additionally, the ideal candidate should be willing to learn and develop new areas of expertise that could include some work on large molecules. This position will report to the Senior Director, Manufacturing Management.

Responsibilities, including but not limited to:
Lead/support CMC projects of Ultragenyx´s portfolio.
Drive required components of the CMC strategy to accomplish CMC team goals.
Conduct integrated planning and cross-functional tracking
Manage CMO relationships using performance management and continuous improvement strategies and tools.
Support global CMC filings.
Manage process optimization where appropriate, tech transfer, and cGMP manufacturing.
Contribute to CMO selection and implementation.
Drive RFPs, SOWs, MSAs, and other governance documents.
Summarize, interpret and escalate appropriately
Promote and implement knowledge management processes for appropriate sharing and storage of documentation

Requirements:
Ph.D. or equivalent work experience in Pharmaceutical, Chemical, or Biological Sciences.
10 years or more of relevant experience in small biotech and/or large pharma environment, working in global organizations as well as leading people.
Demonstrated experience with participation (or leading) on CMC teams, and executing CMC activities.
Proven accomplishments in cGMP manufacturing, and jointly with Quality (e.g. validation, deviation management, QC of small molecules).
Strong project management skills including working knowledge of MS Project, collaboration tools (e.g. SharePoint), and ideally CMC Project Lead experience.
Proven ability to build and sustain CMO relationships.
Excellent problem solving skills and verbal/written communication skills.
Ability to contribute to filing processes (INDs, MAAs, NDAs, and other regulatory related documents.
Ability to work with automated systems and business processes that include Legal, Finance and Accounting, Quality, inventory, and logistics.
Excellent English proficiency, 2nd language e.g. German, Japanese, French welcome, but not required.
Travel approximately 25%.

People Management Skills:
Clarify Direction & Priorities: Set clear direction for your direct reports aligned with functional and corporate goals. Reprioritize work, as needed. Enable others to do their job well by communicating information and making decisions in a clear, timely manner.
Partner & Collaborate Effectively: Listen to and value others’ thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.
Support Learning & Growth: Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others.
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: hr@ultragenyx.com.

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