Vice President, Analytical Development and CMC Quality Control
Novato, CA or Brisbane, CA
Ultragenyx – Quality
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, and Basel, Switzerland.
Ultragenyx is seeking a highly motivated Vice President Analytical Development & CMC Quality Control, who is a team builder and enjoys a fast paced, dynamic work environment. The ideal candidate has demonstrated leadership and knowledge with the development, validation, implementation and maintenance of Biologic and Pharmaceutical analytical methods and is capable of obtaining tangible results in a short period of time. The position has the responsibility of engaging in and overseeing the development and implementing of all product test methods to ensure the implementation of an effective product control plan and assessment of CQAs in support of product lifecycle management. The leader will work collaboratively with both internal and external executives to include Analytical Development, Technical Development, Technical Operations, Translational Sciences, Quality and Regulatory to ensure timely and robust implementation of the appropriate control system. The leader must be capable of representing the approach and control plan in regulatory inspections and discussions. The individual and their team will be responsible for authorship of analytical development / QC related sections of Regulatory Filings. This position will report to the EVP Translational Sciences, Chief Quality Operations Officer.
Responsibilities, including but not limited to:
- Build and lead the Analytical Development and CMC QC team to develop, validate, deploy and manage Ultragenyx’s development and CMC QC oversight approach to ensure product quality and compliance with applicable ICH guidelines and FDA/EMA/applicable global health authority requirements and expectations
- Lead development, validation and implementation of novel analytical methods for rare and ultra rare disease across multiple modalities to include small molecule, traditional biologics and mRNA
- Proactively engage in collaboration with internal and external stakeholders to include health authorities and industry trade organizations to identify trends and expectations and incorporate them into Ultragenyx’s analytical development strategy, product control plans and CMC QC management approach
- Utilize process development knowledge, the Quality Management System and Health Authority requirements and expectations as the basis for building and executing the analytical development plan and CMC QC control plan/management approach
- Work with Contract Manufacturing Organizations, Contract Testing labs and Internal teams to include; Tech Ops, Quality, Regulatory and Translational Research to identify Control Plan and/or product quality improvements to ensure continuous improvement of manufacturing processes and product quality
- Actively support inspection readiness activities and associated Health Authority Inspections
- Develop, maintain and implement internal and external processes to satisfy contractual and regulatory requirements
- Establish adequate staffing and schedule to support aggressive growth plan for the company
- Lead authoring and approval of analytical/QC related sections of regulatory filings.
- Oversight and approval of method validation, implementation and QC / control plan changes
- Oversight and approval of QC investigations to include confirmed OOS results
- Monitor and trend method and product performance to include product stability
- Ensure active senior management engagement and visibility to Ultragenyx’s program status and risks through the Quality Management Review process
- Manage and develop Analytical Development and CMC QC staff
- Set team objectives in alignment with business objectives and ensures that targets are achieved.
- Maintain department budget and adherence to business plan and the overall goals and objectives of the company.
- Develops department specific SOPS and standards in support of the Quality System and proactive quality program
- Advanced Degree (MS, PhD) is required in Biological Science, Chemistry or related technical discipline
- 15+ years’ experience in Biotech/Pharmaceutical industry, with at least 10 years in a supervisory capacity
- Experience leading a of analytical development scientists and working in partnership with a process development team to deliver an appropriate control strategy for the associated product
- Strong working knowledge and interpretation of FDA/EU and ICH – GxP regulations and guidelines
- Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
- Experience working with Contract clinical, manufacturing, laboratory and distribution organizations is a plus. Capable of collaboratively engaging with external 3rd parties to effectively execute analytical development and QC oversight
- Experienced in all phases of biologic and small molecule drug development is a plus
- Flexible in the face of shifting needs and/or priorities
- Able to interface well with all levels of personnel, including peers and other department heads such as: Clinical, Safety, Clinical Affairs, Data Management, Biostatistics, Regulatory, Technical Operations, Translational Sciences, Quality Operations, Supply Chain and Program Management
- Experience with computerized systems (eg. LIMs) and their associated compliance requirements
- Capacity to produce high quality results across multiple projects and prioritize demands while working under short deadlines associated with a fast-paced dynamic scientific environment
- Focuses on practical, commonsense and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors as well as robust methods
- Willingness to work in a dynamic and changing corporate environment
- Requires a flexible work schedule to accommodate program priorities and international activities as needed
- 20--30% travel (some international travel may be required)
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.