• Pre-clinical/Life Sciences
  • Waltham, MA

Responsibilities:

  • Practices and promotes safe work habits and adheres to safety procedures and guidelines
  • Team with Engineering to ensure equipment readiness for campaign start
  • Team with facilities and Quality to ensure suite readiness from a change in and compliance stand point
  • Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
  • Proactively directs and delegates staff to ensure the execution of the daily manufacturing schedule.
  • Support and develop consistent manufacturing standards for controlled documents used within cGMP manufacturing
  • Conducts complex document revisions and/or document management including batch production records and manufacturing procedures
  • Performs training with staff on the floor, as needed
  • Supports cross-functional company goals
  • Builds cross-functional relationships and enhances relationships with team members
  • Works cooperatively with others to meet group and organizational goals
  • Meet with operators regularly to discuss goals, planning, and progress.
  • Continuously builds a high-performance diverse team of people to achieve objectives
  • Develops self and others to improve performance in current role and to prepare for future roles
  • Seeks and welcomes feedback and responds to coaching
  • Provides frequent feedback and coaching to others on ways to improve performance
  • Recognizes and celebrates successes
  • Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations.
  • Participate in client and planning meetings as requested

Requirements:

  • Bachelor’s or Master’s degree in Life Sciences, Engineering or related field (preferred)
  • Minimum of 7 years’ management experience in pharmaceuticals manufacturing (OR solid experience as a Lead, Mentor or Trainer)
  • Great knowledge of cGMPs.
  • Strong interpersonal and communications skills; written and oral
  • Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • Ability to make decisions and work with minimal to moderate supervision.
  • Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups
  • Strong planning, organization and multitasking skills
  • Solid understanding of applicable regulatory requirements.
  • Gown aseptically and/or sterile gown as needed.

 

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To apply for this job email your details to info@clinlabstaffing.com