Director, CMC Team Leader – Small Molecule Programs
- 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 (Congenital HI), 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 chemist, chemical engineer, or pharmaceutical scientist to lead the CMC development programs for our portfolio of small molecule drug candidates. They will be responsible for all aspects of CMC strategy, process - analytical development and cGMP manufacturing. They will lead and collaborate with a cross functional CMC/Quality team tasked with defining and delivering CMC objectives necessary to support early to mid-stage development of our small molecule product candidates.
Principle Duties and Responsibilities Include:
- Leads a cross functional - matrixed- internal CMC/Quality team. Establishes and manages the detailed CMC project plan and associated timelines, deliverables and budgets. Defines CMC resource requirements needed to support approved product development activities.
- Represents the CMC team on the global product team(s)
- Acts as primary CMC interface with CDMOs, for both active pharmaceutical ingredient (API) and oral solid dosage forms (OSD). Responsible for establishing and managing the CMC scope-of-work and clinical trial material supply agreements
- Evaluates and leads the selection of CDMOs to support the process – analytical development and cGMP manufacturing of multiple small molecule product candidates. Act as the project and technical lead for small molecule (drug substance and drug product) process and analytical development activities performed at CDMOs.
- Lead facility fit assessments and process/facility gap assessments prior to GMP manufacturing
- Leads Technology Transfers to CMO’s and acts as the primary technical lead for cGMP manufacturing of drug substance and drug product.
- Leads all process and analytical development work performed on behalf of Rezolute at CDMOs.
- Providing technical and scientific leadership as subject matter expert (SME) relating to technology transfers, manufacturing processes, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control and process development and optimization
- Provides leadership and technical guidance for manufacturing investigations. Proposes remedial actions/plans consider both technical and business impacts. Presents proposed solutions and supporting technical data to internal and external stakeholders (including health authorities if required).
- Acts as person-in-plant and technical advisor during tech transfer, start-up, validation studies and clinical manufacturing
- Develop, optimize and review Master Batch Records, test methods and product specifications prior to and during development and clinical manufacturing
- Defines phase-appropriate process and product characterization studies throughout the product development lifecycle.
- Manages overall supply and inventory of drug substance and drug product. Forecasts future manufacturing requirements required to support current and anticipated clinical trials.
- Authors, reviews and approves technical reports.
- Authors and reviews relevant sections of regulatory submissions and dossiers (IND, NDA, IMPD etc.) including responses to Heath Authorities associated with submissions.
- Interfaces with Health Authorities in support of regulatory submissions.
Qualifications/Requirements - We are looking for a candidate with:
- Bachelors or Master’s degree in Chemistry/Chemical Engineering, Pharmaceutical Science or related discipline with a minimum of 10 years relevant industrial experience
- Alternatively, Ph.D. in Organic Chemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Science or related discipline with 7 years of industrial experience
- Experience leading cross-functional project teams
- Direct leadership experience with OSD product process and analytical development and/or formulation
- Demonstrated expertise in organic chemistry
- Demonstrated expert knowledge in DS and/or DP manufacturing and scale-up of small molecule compounds (organic chemical synthesis, crystallization, chromatography, filtration, precipitation, drying, API formulation, spray drying, milling & micronization, API physical characterization, blending, compaction, film-coating, encapsulation, tableting and typical analytical tests for OSD products).
- Experience with SM API and DP manufacturing for oral dosage forms; experience working with Contract Development and Manufacturing Organizations
- Strong scientific and technical experience within relevant manufacturing process technologies and unit operations. Preferably experience with equipment utilized in commercial cGMP manufacturing facilities
- 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
- Project Management certification preferred.
- Ability to travel up to 20% of the time
Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that is:
- Self-starter, with the ability to independently identify and resolve significant scopes of work with minimal oversight and direction.
- The ability to work effectively and lead small matrix and cross-functional teams in a fast-paced environment with a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams.
- 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.