Head of Quality Control
Location: Redwood City, CA
- Rezolute is a clinical stage biopharmaceutical company developing transformative therapies targeting rare and metabolic diseases.
- Recently, Rezolute announced completion of a ~$50M raise. Near-term, the company is preparing to commence Phase 2b clinical studies for its lead program RZ358, an antibody targeting and ultra-orphan pediatric indication as well as advancing its other programs into the clinic, including RZ402, an oral kallikrein inhibitor to treat diabetic macular edema.
- More information can be found at www.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.
- As an integral part of the CMC / TechOps team, provide active management of the Outsource / Contract laboratories supporting pipeline advancement:
- Provide direct oversight of GMP laboratory functionality at CDMO/CMO and CTL’s.
- Act as Subject Matter Expert on assigned scopes of work, using working knowledge of methods, equipment and associated GLPs to ensure vendor right first time execution while driving highest standards of quality
- Ensure compliance with CFR/ICH guidelines in support of drug development and regulatory product submissions strategies and deliverables
- Provides QC technical review for:
- Stability assessments, stability data and trend analysis review, including statistical analysis
- Product characterizations and changes in manufacturing process as applicable
- Test records and raw data related to release testing of drug substance, drug product and reference standards
- Manage non-conforming events: OOT, OOS, Deviations & CAPA – by conducting effective root cause investigations and implementing corrective actions. Continue to monitor effectiveness by data analytics and improvising procedural controls
- Develop, recommend and approve phase appropriate product specifications to support Rezolute pipeline development and commercial activities
- Author technical reports to justify specifications, investigations and expiry/retest periods
- Develop, transfer and validate analytical/bioanalytical methods used to support Rezolute’s in-process, release, stability and reference standard testing programs
- 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
- 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 as required
- 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 8 years in GMP environment in biopharmaceutical analytical experience.
- Direct experience in late phase product development, product validation and commercialization of biologics, experience with small molecule also preferred.
- 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 CMC and eCTD regulatory documents (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
- Experience interfacing with regulatory authorities
- 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