CMC Project Manager

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Location: Bend, OR or REMOTE

Company Description
  • Rezolute is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients suffering from debilitating metabolic diseases.
  • Rezolute’s lead clinical asset, RZ358, is a monoclonal antibody in late-stage development for the potential treatment of Congenital Hyperinsulinism (HI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
  • The company’s second clinical-stage asset, 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
Position Description
Overview

Rezolute is looking for a motivated, independent, and action-driven CMC project manager. The position requires a skilled communicator that has experience in cross-functional project management and working knowledge of CMC operations. The CMC Project Manager role is critical for coordination of CMC and Quality activities of drug development programs in Rezolute’s portfolio. Under supervision of a CMC Program Leader, this position supports partnerships and ensures deliverables are met both internally and with contract development and manufacturing organizations (CDMO’s). Individuals are team-oriented and expected to act as a key point of contact for internal colleagues and external stakeholders.

Principle Duties and Responsibilities Include:
  • Project management of drug substance and drug product development, manufacture, material deployment, and maintenance.
  • Work closely with the CMC Program Director to develop, track and manage integrated CMC/Quality plans and timelines while ensuring deliverables and activities are aligned across all functions.
  • Ensure that CMC and Quality project timelines and dependencies feed into the integrated master project plan and timeline.
  • Identify project risks, gaps, and develop and manage appropriate mitigation strategies.
  • Review CDMO contracts for completeness and generate Purchase Orders for approval.
  • Aid in the management of the CMC project financial management system working with the CMC Program Leader and Rezolute Finance department to account for Scopes of Work pricing, purchasing, invoicing, demonstration of earned value, and budget.
  • Effectively manage team meetings, including the scheduling of meetings, the preparation and distribution of agendas, the development and distribution of meeting minutes and tracking of action items.
  • Facilitate day-to-day communication to ensure clarity, completeness, transparency, and ensure the team is set up to successfully deliver on all CMC project commitments.
  • In combination with QA Document Control and QA GMP Manufacturing leads, help manage Documentation Management for Pharmaceutical, Analytical, Formulation Process Development, and corresponding cGMP activities. Partner daily with Rezolute CMC SME’s, Quality teams and our external vendors to ensure timely receipt, review, approvals, and introduction to our QADC system. 
  • Leads and tracks the CMC technical document management function.
  • Support CMC SME’s with GMP documents including change controls, deviations, and standard operating procedures; Partner daily with Quality Assurance to ensure compliance with cGMP regulations and Rezolute Quality Systems in concert with the Rezolute Quality Assurance.
  • Support and Track CMC content for regulatory filings (IND/IMPD for CTA and BLA).
  • Contributes to best practices, develops value-added PMO tools, and periodically seeks feedback on project management.
Qualifications/Requirements:
  • Minimum Bachelors’ degree in scientific/technical discipline.
  • Minimum 5 years total relevant experience (including industry, project management, or private/government institution), with at least 3 years in a define project management role.
  • Understanding of biotech, cGMP requirements for Upstream and Downstream Biologics Drug Substance development/manufacturing, and/or Aseptic Drug product development/manufacturing.
  • Ability to work independently as demonstrated by establishing their own daily work schedule based on priorities provided by the CMC Program Leader.
  • Demonstrated ability to create, organize and update a complex schedule.
  • Proven track record in a fast-paced, challenging, and complex matrixed, remote-work team environment.
  • High degree of demonstrated learning agility.
  • Action-oriented with strong follow through.
  • Strong attention to detail.
  • Able to effectively manage work performed by staff working remotely.
  • Strong risk management analysis and project management skills.
  • Enjoys describing complex project related activities in a clear and succinct manner.
  • Ability to understand strategic objectives while focusing on execution of near-term details to meet long-term goals.
  • Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel in all levels of the organization; able to gain consensus and commitment
  • Proficient knowledge of Excel, Word, PowerPoint, Project and/or Smartsheet.
Preferred Experience, Special Skills and Knowledge:

Previous project management experience with a biologics-based clinical phase biopharmaceutical company or with a biologics CDMO.

To Apply:

Interested and qualified candidates should send their resume to info@rezolutebio.com to the attention of Human Resources.