Senior Director, Quality Control and CMC Statistics
- Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (CHI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
- The company’s second clinical-stage asset, currently in Phase 1, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
- Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com
Rezolute is seeking an experienced, dynamic leader to build and oversee the Quality Control department and establish the statistical analysis function within the Technical Operations organization. This role provides a critical interface with the broader Rezolute organization 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. The incumbent will be an essential and accountable member of product teams and key advisor to senior management and key stakeholders in the organization in providing statistical expertise. The incumbent will apply fit-for-purpose, advanced and state-of-the-art statistical principles and tools in a wide variety of situations.
- Lead Quality Control activities for clinical and commercial products, including management of in-process, release and stability 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 Operations product teams.
- Apply appropriate statistical methods and tools in cGMP clinical and commercial stability planning, execution, data analysis and data trending in support of product expiry/shelf-life determination. Own the stability programs, with regard to program design, data analysis, trending and regulatory submissions.
- 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
- Develop and implement performance metrics to monitor the health and status of QC method performance; develop and implement improvement where indicated by the data.
- In partnership with CDMO laboratories, lead the qualification and validation of analytical methods and QC test plans in preparation for clinical and commercial manufacturing.
- 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 improved procedural controls
- Provide technical support for site and product related inspections
- Write, review and approve SOPs, specifications, and protocols and technical reports
- Support Annual Product Review (APR) and Annual Report (AR) activities
- Review 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 (e.g., IMPD, IND, MAA, BLA); interface with regulatory agencies on all components of stability and reference standard programs and analytical method qualification and validation.
- Author/review technical reports to support investigations and expiry/retest periods
- Provide statistical expertise for global development in compliance with current ICH / FDA guidelines and QbD current practices.
- Remain current with latest developments in the field of statistics and explore CMC and other applications for our organization.
- Support improvement of data collection and management processes and systems to enable quick and reliable data analysis.
Qualifications/Requirements - We are looking for a candidate with:
- Bachelor of Science with at 10 years of relevant experience in biotechnology/pharmaceutical industry, with hands-on expertise with statistical analysis methods, tools and processes
- Direct experience with analytical method development, qualification, validation and transfer as well as product characterization and analytical comparability
- Direct experience with authoring and review of Module 3 CTD content; experience interfacing with international health authorities
- 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:
- University degree in Chemistry, Biology, Statistics, Data Science or a related field with at least 10 years of relevant experience is preferred
- Self-starter, with the ability to independently identify and resolve significant scopes of work with minimal oversight and direction.
- 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 their resume to email@example.com to the attention of Melissa Quinn.