Sr. Director, Manufacturing Sciences & Technology – Drug Product
- 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
The primary purpose of the position is to lead Drug Product development and manufacturing for antibody and small molecule drug development programs. The Sr. Director must provide technical and scientific expertise to the CMC teams accountable for clinical and commercial drug product development.
The Sr. Director leads the design and execution of complex experiments with sound scientific and engineering principals to resolve problems, recognizes and resolves problems under minimum guidance and executes against specific deliverables developed by the CMC team and executed at CDMO organizations. The Senior Director creates proposals to reduce risk and develop CMC programs to meet global regulatory standards and expectations. Additionally, the Sr. Director occasionally serves as Process Science representative on project teams.
- Design experiments to be conducted at CDMO organizations, including Drug Product process characterization and validation in support of commercial process development.
- Provides technical and scientific oversight to CDMO partners in the execution of development, characterization and validation studies.
- Leads the tech transfer and establishment of cGMP Drug Product manufacturing processes at CDMO organizations
- Leads the establishment of Drug Product manufacturing Critical Process Parameters (CPPs), developed by leading the CMC team in the execution of industry- standard risk assessment processes such as FMEA and PHA.
- Supports Drug Product manufacturing preparation, execution and disposition by providing technical expertise in the development of master batch records, in-process controls and operating conditions, batch record technical review and resolution of deviations and implemention of corrective actions.
- Executes Initial Facility Fit assessments for Drug Product c GMP Manufacturing facilities.
- This position identifies and proposes continuous process improvements. The incumbent independently executes process and procedural changes to improve Drug Product Manufacturing process performance, robustness, productivity, safety and efficiency
- 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 Drug Product Process Development, Characterization, Validation and Manufacturing
- 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:
Bachelor’s/Master’s degree from an accredited institution with six plus years’ experience OR PhD from an accredited institution with four plus years of industry experience
- Demonstrated Technical knowledge in Drug Product Process Development and cGMP manufacturing. Technical knowledge of antibody (sterile liquid and lyophilized) and small molecule (solid and capsule oral dosage forms) Drug Product/aseptic manufacturing principles, techniques, facilities and equipment
- Understanding of validation of biopharmaceutical facilities, equipment and process. The Director/Sr. director must have expert knowledge of Drug Product processes and related manufacturing equipment and facility attributes.
- Proven skills building and maintaining productive relationships with organizational partners such as manufacturing and quality and external service providers such as CDMOs
- Experience with writing technical sections of CTD documents such as INDs, NDAs, IMPDs, MAAs and BLAs
- Direct experience in mid to late phase product development, product characterization and commercialization of monoclonal antibody and small molecule products
- 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; Ability to lead effectively in a matrixed organization
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 firstname.lastname@example.org to the attention of Melissa Quinn.