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CMC Operations Manager

Cambridge, MA

Posted: 08/13/2019 Employment Type: Contract Job Category: Clinical: General Job Number: 2420

Our client is seeking a CMC Operations Manager in their Pharmaceutical Development and Manufacturing Sciences Department (PDMS) to help advance the development of their growing pipeline of product candidates and ensure that drug products are ready for clinical studies, regulatory filings and commercial scale manufacturing. Reporting to the Head of PDMS, the CMC Operations Manager will be responsible for developing and implementing effective project management and business processes within the PDMS organization.

Responsibilities:
  • Develop and optimize business processes within the department to support the CMC and technical development (formulation, process, analytical) strategies
  • Partner with CMC Scientific Leads and cross-functional business partners on multiple complex development projects to achieve product development and manufacturing goals
  • Interface with a global network of CDMOs to support development projects planning and implementation including timelines, materials, documentation and tasks management, issues resolution, and overall projects coordination. The incumbent will act as the CDMO relationship manager for one or more CDMO’ s in their respective area of accountability
  • Lead and/or participate in cross-functional initiatives to improve NDA filling readiness (e.g. data integrity and tracking) and to expand capabilities (formulation, process and analytical)
  • Participate in the development and reporting of key performance indexes (KPI’ s) including productivity measures. Lead the development and integration of tools and infrastructure to enable efficient decision making and results tracking
  • Effectively communicate with CMC team members, senior leaders and business partners such as Regulatory, Quality, TechOps, Clinical Ops, Program Management, Finance others on risks/mitigation plans, resources & budgeting.
  • Establish and manage collaboration team sites (e.g. SharePoint Online)
  • Initiate and monitor the preparation of regulatory documents by CMC and relevant team members including O0365R document management (regulatory portal for uploading and declaring/locking records)
  • Provide project management support for CMC teams/sub-teams and specific initiatives such as source document management (including managing historic files) and SOPs including authoring. Record and issue meeting minutes.
  • Facilitate quarterly resource planning for projects under an existing Development Agreement with a 3rd party
  • Act as PDMS owner for Change control management • Submit and route the contracts in SAP
  • Develop and maintain integrated CMC project plans to identify interdependencies and critical path activities across development programs.

Requirements:
  • Bachelor’ s degree in a scientific or engineering discipline with 5-7 years’ experience, or master’ s degree with 3-5 years of relevant experience required.
  • Previous experience in CMC pharmaceutical development in a virtual organization preferred.
  • Significant experience with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) required; experience with SharePoint software preferred.
  • Good knowledge of cGMP/GLP regulations, ICH, FDA and CMC Guidance Documents.
  • Functional knowledge of biopharmaceutical and/or pharmaceutical CMC development, Process Development, Supply Chain building, Regulatory Affairs, Quality Assurance, and Quality Control.
  • Strong project management, problem-solving, decision making, collaboration, influence, and facilitation skills.
  • Attention to detail, with the ability to critically evaluate documentation (e.g., draft/final reports, source data, etc.).
  • Effective organizational skills and ability to work in a small, dynamic, fast-paced environment with changing deliverables and timelines.
  • Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations.
  • Goal-oriented, highly self-motivated and self-directing individual who works well in a team.

Sam Williams
Clinical Recruiter

Sam brings great enthusiasm and a passion for the life sciences to his role as Clinical Recruiter for The Steely Group. Outgoing and driven with a great sense of humor, Sam connects easily with people and prides himself on his ability to cultivate lasting relationships. He values honesty, communication and empathy in a candidate, and has a genuine interest in helping others achieve their professional goals.

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