Director, CMC-QC Biologics & Oligonucleotides

Ultragenyx

  • Novato, CA
  • Permanent
  • Full-time
  • 22 days ago
Position Summary:ultraimpact - Make a difference for those who need it mostUltragenyx is looking for an experienced professional as Director of CMC Quality Control (CMC QC) with a passion and creativity to manage the quality control aspects of product life cycles for rare and ultra-rare diseases. This role will report the head of Biologics CMC-QC. The key responsibilities will include:
  • Leading all the analytical and CMC control testing activities for the production of Ultragenyx toxicology, clinical trial and commercial products
  • Managing contract organizations including CMOs and Contract Laboratories (CLs) to ensure appropriate compliance with ICH and regulatory quality standards
  • Working with cross-functional teams, including Technical Operations, Technical QA, Project Management, Supply Chain and Regulatory to achieve corporate goals and objectives
  • Develop internal system to manage QC technical knowledge base for all Biologics & Oligonucleotides assets
The successful candidate must be proficient in QC and Analytical platforms for Biologics & Oligonucleotides. Th ideal candidate have a track record of cGMP and CMC-QC experience. The candidate has an end-to-end CMC regulatory drug approval process knowledge for Biologics & Oligonucleotides, 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 Company working on fascinating clinical molecules focused on developing life-transforming therapeutics for patients with rare and ultra-rare diseases. The 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 innovative team for the development of the company's next generation products.Work Model:Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.Responsibilities:
  • Provide strategic guidance on all QC related agenda for Biologics & Oligonucleotides assets. Collaborate with analytical development or CRO on method selection, development, qualification/validation, technical transfer and troubleshooting.
  • Execute technical review of analytical data, data integrity and laboratory documentation, method validation protocols, method validation summary reports, and method development reports
  • Participate in the selection of CMOs and CLs (contract laboratory) for testing support of new and existing projects. Lead the selection of the CLs for analytical method development, validation and testing. Manage the stability programs Reference standard programs and establish shelf-life.
  • Champion, lead and participate in continuous improvement activities for the quality control and analytical development operations
  • Collaborating with cross-functional teams: The Director, CMC-QC Contracts management works with cross-functional teams within Ultragenyx to ensure that contract organizational needs are met. This may involve working with Analytical development, QC, contract organizational teams, and regulatory affairs.
  • Providing strategic input: The Director, CMC-QC Contracts management may be called upon to provide strategic input on QC activities at global contract organizations and serve as QC representation during clinical or commercial campaigns. This involves staying up to date with CMC-QC and CMC sub teams to proactively identify opportunities to solve challenges.
  • Managing contracts and agreements: The Director, CMC-QC Contracts management is responsible for managing contracts and agreements with contract organizations, partners, and stakeholders. This involves negotiating terms and conditions, ensuring compliance with regulatory requirements, and managing any disputes that may arise
  • Manage the qualification/validation of analytical test methods for all Product Quality parameters, specification setting, managing stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines
  • Author, update, and revise CMC regulatory filing sections to support regulatory filings. Support inspections/audits (regulatory or internal) and author audit observation responses
Requirements:
  • Master's degree in Cell Biology, Molecular Biology, Biochemistry or a related life science field; PhD degree is highly desirable
  • Experience with a minimum of 10-12 years in a GMP environment (Biopharmaceutical Industry) with at least 5- 8 years in CMC-QC environment supporting release and stability management of clinical and commercial assets
  • Excellent knowledge in biological molecules methods, including RP-HPLC, IEX, SEC, SDS-PAGE, ELISA and Bioassay, Western blot, 2D western blots, CE and CIEF. Expertise and familiarity with most of the following characterization techniques including LC-MS, MALDI-TOF-MS, CD, FTIR, DSC techniques
  • Excellent oral and written communication skills in English and European languages (preferably German and/or Italian), and proven ability to work autonomously and manage effectively in a matrix environment.
  • Proficiency in MS Office, Word and Excel - Proficiency in statistical analysis (e.g. JMP) software desired
  • Attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines
  • Excellent interpersonal and verbal communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company
  • Travelling to the US head office and other global CMO/CRO sites will be required - 25% #LI-CS1 #LI-Hybrid

Ultragenyx