Associate Director of Manufacturing Operations

1 week ago

Bend, United States Rezolute, Inc. Full time

Position Description

Rezolute is seeking an experienced individual who can help lead its external late-stage manufacturing operations. The Associate Director of Manufacturing Operations is expected to be a motivated, independent, and action-driven individual who understands the intricacies between Pharmaceutical Manufacturing and Quality Assurance. This role is fast-paced and will be responsible for defining the program and cGMP manufacturing strategy that leads to a robust process for the commercialization of RZ358.


Under the supervision of the Senior Director – Supply Operations, this position manages partnerships and ensures deliverables are met both internally and with contract development and manufacturing organizations (CDMO’s). Responsibilities include oversight of multiple Drug Substance (DS) and Drug Product (DP) sites to ensure deliverables are achieved based on the approved plan. This role will act as a technical lead while also interacting with internal SME’s (MSAT and QA) to ensure proper execution. 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:

Responsible for the manufacture of DS and DP based on approved plan; acts as technical and business lead where applicable

  • Review all CMO contracts to ensure deliverables meet defined strategy
  • Liaison with Internal SME’s (MSAT and QA) to ensure activities are fully coordinated with the POR
  • Lead Internal MFG Operational Alignment Meetings
  • Develops facility fit assessments and process/facility gap assessments to enable Technology Transfers to future CMO’s
  • May act as person-in-plant and technical advisor during tech transfer, start-up, validation studies and clinical manufacturing
  • Ensures Master Batch Records and product specifications are finalized and in place prior to any cGMP manufacturing
  • Reviews the overall supply and inventory of drug substance and drug product
  • Authors, reviews, and approves technical reports.
  • Attend Internal and External Technical Sub-term meetings to ensure consistency
  • Participate in the generation and maintenance of 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.
  • Review program related Gantt charts and Dashboards
  • 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.
  • Help 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.
  • 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.


Qualifications/Requirements:

  • Minimum Bachelors’ degree in scientific/technical discipline.
  • Minimum 8 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.
  • Clear understanding of clinical FDP execution
  • 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.


Preferred Experience, Special Skills, and Knowledge:

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

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