Location: Bend, OR
- Rezolute is a clinical stage biopharmaceutical company dedicated to advancing therapies for rare, metabolic, and life-threatening diseases.
- In October 2020, Rezolute announced a $41 million private placement which was led by CAM Capital with Federated Hermes Kaufmann, Surveyor Capital and BVF Partners participating, among others.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead asset, RZ358, which is a potential treatment for CHI, a rare pediatric endocrine disorder.
- Rezolute is preparing to initiate a Phase 1 study, for RZ402, in Q1 2021. RZ402 is an IND-ready orally available plasma kallikrein inhibitor for the treatment of diabetic macular edema.
- Earlier this year, Rezolute received a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com
The CMC Coordinator will play a pivotal role in daily execution of Pharmaceutical Drug Development and GMP Manufacturing activities supporting advancement of the product pipeline. The CMC Coordinator will directly report to the CMC Team Lead and work hand in hand with functional leaders and experts. The CMC Coordinator will establish and maintain the pivotal systems and tools necessary for robust on-time completion of critical CMC program activities to include project management, vendor management, financial management, GMP and Development documentation management, and Manufacturing systems and procedures establishment within a cGMP regulated environment. This position requires excellent communication, collaboration, organization, multi-tasking, planning, documentation and influencing abilities. The position will be directly supporting members of the CMC team whose direction will support daily work assignment and execution methodology.
- Provide CMC project management supporting early to late phase pharmaceutical program advancement.
- Oversee Documentation Management for Pharmaceutical, Analytical, Formulation and Process Development as well all cGMP activities in conjunction with Quality Assurance Document Control. The position will work daily with the CMC and Quality teams and our external vendors to ensure timely receipt, review, approvals and introduction to our QADC system. Leads the CMC technical document management function.
- Supports coordination of day-to-day project planning, meetings, budgeting, tracking, resourcing (external/internal) and execution of CMC activities; Ensures CMC activities are progressing actively toward program goals striving to achieve agreed timelines, milestones, and resource / budget forecasting
- Owns the CMC project financial management system working with the CMC Program Lead and finance department to account for Scopes of Work pricing, purchasing, invoicing and demonstration of earned value
- Directly interfaces with external vendor network supporting the program including Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), Contract Laboratories (CTLs) and consultants
- Coordinates CMC meetings and acts as the Point of Contact (POC) with associated vendor network for project communications (email, memos, reports, data, proposals, scopes of work (SOWs))
- Authors GMP documents to include change controls, deviations, and standard operating procedures; Works daily with Quality Assurance to ensure compliance with cGMP regulations and Quality Systems in concert with Quality Assurance
- S. degree in chemistry, biology, pharmaceutics, engineering, or related scientific field
- A minimum of two years of experience in the pharmaceutical industry with prior experience in a CMC environment
- Excellent communicator both verbal and written
- Proven ability to work independently, proactively; works daily with cross-functional teams and senior management
- Strong collaborative and relationship-building skills
- Ability to effectively prioritize and deliver high-quality results on tight timelines
- Experience and competence with Office365 tools
- Ability to generate Gantt charts, spreadsheets and presentations
- Prior formal project management in a pharmaceutical/biotechnology setting is strongly desired
- A passion for the work you do and the people you do it with!
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Melissa Quinn.