Director, CMC Quality Control - Brisbane, CA | Biospace
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Director, CMC Quality Control

Ultragenyx Pharmaceutical Inc.

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Location:
Brisbane, CA
Posted Date:
9/14/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Director, Quality,

Job Description


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 located in Novato, CA, 25 miles north of San Francisco with an additional office in Brisbane, California.

Position Summary:

Ultragenyx is searching for an experienced professional as Director of CMC Quality Control (CMC QC) with the passion and creativity to manage the quality control aspects of product life cycles for rare and ultra-rare diseases.  The Director will be responsible for leading all the analytical and CMC activities for the production of Ultragenyx toxicology, clinical trial and commercial products.  He or she will work with contract organizations including CMOs and Contract Laboratories (CLs) to ensure appropriate ICH and regulatory quality standards are met during product development and production, prior to the release and post approval of our products.  This position will collaborate closely with cross-functional departments such as TechOps, Technical QA, Project Management, Supply Chain and Regulatory to achieve corporate goals and objectives.

The successful candidate must be proficient in biological assays development (ELISA and cell based assays) and end to end CMC regulatory drug approval process for biologic products, be a self-starter with the ability to work independently under minimal supervision, and who is seeking to be part of an innovative and fast-paced team.  This is a rewarding opportunity to join a commercial bound clinical stage biotech company focused on developing life transforming therapeutics for patients with rare and ultra-rare diseases.  This individual will be instrumental in bringing the company’s therapeutic products from early-discovery development stage to commercial launch and be a critical part of creating an innovation team for the development of the company’s next generation products.

Responsibilities, including but not limited to:
•   Manage the development and validation of analytical test methods with an emphasis in biological assays, specification setting and stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines
•   Execute technical review of analytical data, data integrity and laboratory documentation, method validation protocols, method validation summary reports, and method development reports
•   Author, update, and revise CMC regulatory filing sections to support regulatory filings
•   Participate in the selection of CMOs and CLs for support of new and existing projects
•   Ensure compliance with current GMP’s in a manufacturing environment such that the products are assessed to agreed-upon specifications in a timely manner in order to support in-process, lot release and stability testing
•   Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines
•   Maintain QC project plans and their associated timelines
•   Perform deviation investigations and CAPA implementation in support of CMC QC projects and improvement
•   Support inspections/audits (regulatory and internal) and draft audit observation responses
•   Responsible for planning, tracking, monitoring and adhere to annual budget
•   Supervise a small team or contractor when applicable
•   Champion, lead and participate in continuous improvement activities for the quality control operations

Requirements


•   Master’s degree in Cell Biology, Molecular Biology, Biochemistry or a related life science field; PhD degree is highly desirable
•   Working experience with a minimum of 12 years in a GMP environment (Pharmaceutical or Biotech industries) with at least 8 years in analytical method validation
•   Experienced in executing ELISA and cell based potency and activity assays and molecular biology (ie, mRNA technology) characterization and applicable analytical test method validations for raw materials, intermediates, DS and DP of biologic products
•   Excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrix environment
•   Proficient in project and personnel management, excellent organizational skills and the ability to work on multiple projects with tight deadlines
•   Excellent interpersonal and verbal communications skills and the ability to influence in a dynamic cross-functional team
•   Proficiency in MS Office, Word and Excel - Proficiency in statistical analysis software desired

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