Director, Quality Control
Location: Redwood City, CA
- Rezolute is a clinical stage biopharmaceutical company developing transformative therapies targeting rare and metabolic diseases.
- Near-term, the company is advancing its lead asset in a Ph 2b trial in an orphan indication and is planning to advance another asset to clinical stage in 2020.
- More information can be found at rezolutebio.com
Rezolute is seeking an experienced and dynamic leader to build and oversee the Quality Control department. This role is a fundamental interface with the Technical Operations group and global vendors, providing Quality Control oversight and collaborating on GMP execution to support advancement of biologics and small molecule programs including development of QC method lifecycle activities and organizational development.
- Lead Quality Control activities for clinical and commercial products, including management of in-process and release testing of GMP Biologics and small molecule products.
- Develop Quality Control strategy and direction in conjunction with the development of analytical methods and manufacturing processes by Technical Development teams.
- Oversee GMP clinical and commercial stability planning, execution, data analysis and data trending in support of product expiry/shelf life determination.
- Qualify and maintain reference standards for all Rezolute programs
- Oversee Quality Control requirements for compliance with cGMP/CFR/ICH regulations and guidelines at external contract manufacturing and testing organizations
- Drive continuous improvement projects in collaboration with internal and external stakeholders.
- Work closely with CMOs, CTLs and Technical Operations to coordinate and execute GMP related activities with respect to timelines and compliance.
- Develop and implement performance metrics to monitor key process health and drive prioritization of improvement activities to ensure delivery of scientifically sound and efficient QC methods
- Identify and address technical and validation gaps in analytical methods and QC testing in preparation for clinical and commercial product.
- 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
- Provide technical support for site and product related inspections
- Write, review and approve Quality Control SOPs, specifications, and verification protocols and technical reports
- Support Annual Product Review (APR) and Annual Report (AR) activitiesReview notebooks and data packages at release and stability to ensure analytical methodology is followed at drug substance CMOs and CROs
- Author relevant sections of regulatory submissions and response materials (eg IMPD, IND, MAA, BLA); interface with regulatory agencies on all components of stability and reference standard programs
- Author technical reports to support investigations and expiry/retest periods
Qualifications/Requirements - We are looking for a candidate with:
- Bachelor of Science with at 15 years of relevant experience in biotechnology/pharmaceutical industry
- Direct experience with analytical method development, validation and transfer as well as product characterization and analytical comparability
- Prior experience with authoring and review of Quality owned regulatory filing sections (e.g. JOS, comparability, method summaries etc.)
- Comprehensive knowledge of current Good Manufacturing Practices (cGMPs) and multi-national regulations
- Ability to travel up to 20% of the time
Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that is:
- Advanced degree (M.S., Ph.D.) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 10 years of relevant experience is preferred
- 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 email@example.com, to the attention of Melissa Quinn