Director, Quality Control
Location: Location: Redwood City, CA
- Rezolute is a clinical stage biotech developing transformative therapies targeting rare and metabolic diseases. Recently, Rezolute announced completing a $45M raise.
- Near-term, the company is advancing its lead ultra-orphan pediatric therapy in Phase 2b studies this year in the US and Europe. The Company is also planning to up-list onto a national exchange in the near term.
- More information can be found at rezolutebio.com
Rezolute is seeking an experienced and dynamic leader to build and oversee the Quality Control function in support of Rezolute and strategic partner pipeline advancement. The candidate will have full responsibility for department budget and will be responsible for QC method lifecycle management activities and organizational development.
- Build a QC organization to include internal resource and establishment/management of external testing resource.
- Develop, recommend and approve phase appropriate product specifications to support Rezolute pipeline development and commercial activities
- Develop analytical methods and QC testing at external testing labs, CMO’s and strategic partners
- Manage non-conforming events: OOT, OOS, NCR & CAPA – by conducting effective root cause investigations and implementing corrective actions. Continue to monitor effectiveness by data analytics and improvising procedural controls
- Review notebooks and data packages at release and stability to ensure analytical methodology is followed at drug substance CDMOs, CMOs and CTOs
- Author technical reports to justify specifications, investigations and expiry/retest periods
- Ensure GMP work at relevant CMOs/CTOs is performed in compliance with CFR/ICH guidelines
- Develop, transfer and validate analytical/bioanalytical methods used to support Rezolute’s in-process, release and stability testing programs
- Write, review and approve Analytical Development and QC SOPs, specifications, method validation, verification protocols and technical reports
- Design and execute strategic studies and evaluations in support of product development activities
- Support due diligence efforts for potential in-licensing activities
- Author relevant sections of regulatory submissions and response materials; interface with regulators on all components of QC, Analytical Method Validation and Product Specification establishment
- Develop and implement product and manufacturing process performance metrics in order to monitor key process and program health
- Collaborate with team members and help drive the development and prioritization of outsource improvement activities and the efficient delivery of optimized and actionable QC methods
- Provide technical support for site and product related inspections
- Support Annual Product Review (APR) and Annual Report (AR) activities
- Identify and address technical and validation gaps in analytical methods and QC testing in preparation for all clinical activities including BLA submission and product commercialization
Qualifications/Requirements - We are looking for a candidate with:
- Advanced degree (M.S., Ph.D.) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 10-15 years of relevant experience is preferred
- Direct experience in late phase product development, product validation and commercialization of biologics.
- Direct experience with analytical method development, validation and transfer as well as biologics product characterization and analytical comparability
- Prior experience with authoring and review of Quality owned regulatory filing sections (e.g. JOS, comparability, method summaries etc.)
- Prior experience with external testing vendors/facilities in support biologics drug development and manufacture.
- Comprehensive knowledge of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices and multi-national regulations
- Ability to work in a virtual environment leveraging external collaborations to accomplish individual and team goals
Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that has:
- Strong leadership skills and ability to effectively communicate up, down and across the organization
- Ability to effectively prioritize and deliver high-quality results on tight timelines
- Excellent written, verbal communication and presentation skills
- Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues
Interested and qualified candidates should send resume to firstname.lastname@example.org, to the attention of Melissa Quinn