External Business Operations Project Leader – CMO Manager

Reference Number: 895456-W
Type of placement: Contract, Contract, 2 years
Location: Switzerland, North West

Introduction:

The External Business Operation Project Leader manages clinical manufacturing at third parties and acts as key account to Contract Manufacturing Organizations. Ensures oversight on production schedules and drives Target Assessments, Quality Agreements and Product Specific Amendments. Actively contributes to Make versus Buy (MvB) Evaluations and leads the technical evaluation in Request for Proposal (RFP) discussions.

Main Responsibilities:

  • Contributes to triage meetings with regards to technical capability for RFP and MvB evaluations considering project team’s requirements
  • Has the overview on projects ongoing at assigned CMOs
  • Responsible for all scheduled clinical and GMP batches at CMO
  • Drives target assessment of assigned CMOs
  • Contributes to GMP audit as Co-auditor of assigned CMOs where assigned
  • Drives establishment, review and update of QA frame agreement and Product Specific Amendments of assigned CMOs
  • Drives quality risk assessment of assigned CMOs
  • Ensures updated technology and equipment list of assigned contractors
  • Provides input to monthly dashboard reporting
  • Tracks and follows up on set KPI for assigned CMOs
  • Accountable for outsourced clinical manufacturing tasks
  • Drives performance control, quality reviews and 3rd party technical reviews of assigned CMOs along preparing the vendor assessment report
  • Collaborates with internal and external teams to ensure requirements at CMO are covered
  • Reviews MBRs compiled by CMO
  • Supports the CMO and the formulation project lead to formulation related questions
  • Manage Deviations and Investigations for technical batches
  • Performs BRR and opening/close-out of deviations for external clinical batches as deviation owner
  • Collaborate with other External Business Operations Project leader (EBO PL) colleagues driving harmonized and aligned approaches and making sure agreement is in place with Create, CMOs, Third Party QA and/or Release QA

Qualifications and Experience:

  • Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent)
  • 2 years of practical experience in pharmaceutical industry or 2 years of experience in field of expertise
  • Adequate (IT) application know how to fulfil role
  • Profound knowledge about the Drug Development process
  • Experience in QAA management and audit needs for excipient qualification
  • Excellent project management, organization, planning skills.
  • Knowledge of Health, Safety and Environment (HSE) and GMP standards, systems and processes
  • Demonstrates problem-solving and idea generation skills
  • Excellent communication, negotiation and interpersonal skills
  • Ability to work in interdisciplinary teams
  • Preferably sourcing and logistics experience
  • Fluent in English language, German and/or French are additional assets
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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