Sr. Director, Analytical Sciences
- 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 and dynamic leader to build and oversee the Analytical Sciences function in support of Rezolute and its strategic pipeline advancement. The incumbent will act as the Product Lead for all Rezolute product candidates in clinical development. The candidate will be responsible for drug substance and drug product analytical method lifecycle development activities and operational execution to support advancement of biologics and small molecule programs in a fully externalized manufacturing and testing environment.
- Act as the Product Lead on the CMC team for early to late-stage clinical products; lead and manage Product and Analytical development from pre-clinical development to commercialization
- Accountable for product characterization and product comparability study design and execution, conducted through outsourced CDMO laboratories
- Establishment for development of associated analytical methods used in support of product characterization and comparability studies
- Establishment and justification of product specification and Critical Quality Attributes across the development lifecycle
- Development, optimization and establishment of in-process test methods, release and stability methods
- Provide active management of the Outsource / Contract laboratories and facilities supporting product development objectives
- Collaborate with QC to establish and execute overall analytical lifecycle management strategy.
- Provide technical review and assessment prior to submission of data to Quality and/or Regulatory Affairs:
- Review CMO/CTLs protocols (method development, qualification, validatation, etc.), reports, and data.
- Product characterizations and changes in manufacturing process as applicable
- Upon QC request, support the evaluation of test data from Test records and raw data related to release testing of drug substance, drug product, critical reagents and reference standards
- Author and/or review technical reports to justify specifications, investigations and expiry/retest periods
- Author relevant sections of regulatory submissions and response materials; interface with regulators on all components of Analytical Method Development, Validation and Product Specification establishment, and Analytical Product Characterization.
- Support Annual Product Review (APR) and Annual Report (AR) activities as required by Quality
- Support due diligence efforts for potential in-licensing activities as assigned
Qualifications/Requirements - We are looking for a candidate with:
- Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 6 years in GMP environment in biopharmaceutical analytical or process development experience.
- Direct experience in early to late phase product development, product characterization and commercialization of monoclonal antibody and small molecule products
- Direct experience with analytical method development, validation and transfer as well as monoclonal antibody product characterization and analytical comparability
- Prior experience with authoring and review of CMC and eCTD regulatory documents
- Comprehensive knowledge of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices and global regulations
- Must be willing to travel domestically and internationally as required (up to 25%)
- Ability to work in a highly collaborative, virtual, entrepenurial 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
- Act with HONOR: Honesty, Open with Direct Communication, Nimbleness, Open-minded, Respect
Interested and qualified candidates should send their resume to email@example.com to the attention of Melissa Quinn.