Position Description
The Program Operations Manager is expected to be a motivated, independent, and action-driven individual who understands the intricacies between Pharmaceutical Manufacturing and Quality. The position requires a skilled communicator who has experience in cross-functional management and working knowledge of manufacturing biologics. This role is fast-paced and will focus primarily on ensuring the close internal and external coordination of drug manufacturing programs in Rezolute’s portfolio.
Under the supervision of the Senior Director – Supply Operations, this position supports partnerships and ensures deliverables are met both internally and with contract development and manufacturing organizations (CDMO’s). Responsibilities include day-to-day planning, coordinating, and tracking critical activities and information flow between CDMOs, as well as driving project timelines to keep the project on schedule and within budget and scope. Individuals are expected to be team-oriented and to act as a key point of contact for internal colleagues and external stakeholders.
Principle Duties and Responsibilities Include:
- Provide day-to-day management of ongoing manufacturing tasks with internal stake holders (MSAT, QC, and QA) and external vendors.
- Track and manage the integrated Global Supply plans and timelines, ensure deliverables and activities are aligned across all functions, and confirm dependencies feed into the integrated master project plan and timeline.
- Generate program related Gantt charts and Dashboards
- 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.
- Institute, and, as appropriate, facilitate, cross-functional program/project teams that are empowered to identify program gaps and manage deliverables.
- Proactively, and independently, identifies and resolves project team challenges.
- Review CDMO contracts for completeness and generate Purchase Orders for approval.
- Aid in the management of the manufacturing project financial management system working with the Senior Director – Supply Operations, Senior Manager -Global Supply Planning, and Rezolute Finance department to account for Scopes of Work pricing, purchasing, invoicing, demonstration of earned value, and budget.
- 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 with Rezolute MSAT SME’s, Quality teams and our external vendors to ensure timely receipt, review, approvals, and introduction to our QADC system.
- Support 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.
- Develop knowledge of the current therapeutic environment and drug development trends as needed.
- Participates in work-related professional organizations and represents the Company in appropriate professional public forums. Integrates scientific and business objectives to maximize program success.
Qualifications/Requirements:
- Minimum Bachelors’ degree in scientific/technical discipline.
- Minimum 5 years total relevant experience (including industry, project management, or private/government institution)
- 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 Senior Director.
- 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 Microsoft Teams, Excel, Word, PowerPoint, and Smartsheet.
- Continuing education in Project Management best practices is required.
Preferred Experience, Special Skills, and Knowledge:
Previous management experience with a biologics-based clinical phase biopharmaceutical company or with a biologics CDMO.
