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Senior Manager
External Manufacturing
Confirmed live in the last 24 hours
Cambridge, MA, USA
Experience Level
Desired Skills
  • Bachelor of Science and 7+ years' experience in project management / biologics manufacturing required; C&GT preferred
  • Understanding of external manufacturing operations and quality systems required
  • Experience or understanding of clinical supply chain planning, raw material supply, chain of identity, etc
  • Knowledge of cGMP requirements is a must
  • Leadership skills with a PM track record of delivering on established goals & objectives
  • Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders and senior management
  • Provide oversight of CDMO operations including supply planning and production plans, management of manufacturing vendor change notifications; lead or assist with manufacturing deviations, customer complaints, and product failure investigations
  • Organizes proposal responses, establish data repository and supports the development of outsourcing models, vendor evaluation, and CMO selection in close collaboration with key internal stakeholders
  • Project Management of CDMO's and critical suppliers; including driving cadences for budget planning & tracking, contracts, and manufacturing tactical execution
  • Establish and foster strong collaborative relationships with external manufacturing counterparts & partners and service providers
  • Establish and maintain detailed project plans, drive risk management program cadence
  • Support supply planning by driving cadence, collecting and organizing data into meaningful output
  • Resource planning, generating metrics/ KPIs, and presentation of materials for internal stakeholder review
  • Travel for in-person interactions with multiple contract manufacturing entities to ensure production is on plan and to foster good relations
  • Perform other related duties and ad hoc projects as required by position and in support of the Head Supply Chain and External Manufacturing
Prime Medicine

51-200 employees

Gene editing biotechnology company
Company Overview
Prime Medicine's mission is to transform the lives of patients with debilitating diseases through the application of our groundbreaking Prime Editing platform and technology. The company uses Prime Editing, a next-generation gene editing approach that they believe can address the genetic cause of disease and potentially provide patients with long-lasting cures.