Associate Director, Analytical Development and CMC Quality Control
Company: Ultragenyx Pharmaceutical Inc.
Posted on: September 23, 2018
Why Join Us? Be a hero for our rare disease patients Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives. Come join our team during this exciting time of growth and opportunities Position Summary: ultra curious - Apply your biggest ideas in courageous ways Ultragenyx is seeking a highly motivated and experienced professional as Associate Director of Analytical Development and CMC Quality Control. The ideal candidate has demonstrated knowledge in managing the analytical and quality control aspects of product life cycles for rare and ultra-rare diseases. The position will be responsible for leading all the CMC analytical activities for the production of Ultragenyx toxicology, clinical trial materials 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. This position will collaborate closely with cross-functional departments such as TechOps, Quality Assurance, Project Management, Supply Chain and Regulatory to achieve corporate goals and objectives. The successful candidate must be proficient in analytical method development/qualification/validation, product characterization and end to end CMC regulatory drug approval process for biologic products. 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 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: Lead the analytical activities for IMP drug substance (DS) and drug product (DP)/placebo from GLP Tox to GMP manufacturing (Phase I-III), including method development to support process development and product release/stability, specification setting, stability program, reference standard, regulatory filing, change control, QC investigations (OOS, discrepancy), and client Quality oversight of CRO/CMO QC operations. Manage the development and validation of analytical test methods used to release and stability monitoring of the clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines Manage analytical method transfer process from development labs to QC testing sites, if required. Provide strategic guidance on molecular structural characterization of protein and mRNA products. Provide technical review of analytical data, data integrity and laboratory documentation, method development reports and method validation protocols/reports. Author, update, and revise CMC regulatory filing sections to support regulatory filings. Address CMC comments regulatory responses. Participate in the selection of CMOs and CLs (contract laboratory) 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. 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 Chemistry,Biochemistry or a related life science field; PhD degree is highly desirable. Working experience with a minimum of 8 years in a GMP environment (Pharmaceutical or Biotech industries) with working knowledge in analytical development and quality control activities. Experience and knowledge in molecular structural characterization. Mass spectrometry expertise in protein and mRNA characterization is highly desired. 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 Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit 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 : hrultragenyx.com .
Keywords: Ultragenyx Pharmaceutical Inc., Parkway-South Sacramento , Associate Director, Analytical Development and CMC Quality Control, Executive , Novato, California
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