Technology Transfer Project Manager I

Description

Job Description: The Technology Transfer Project Manager I is relied upon for leading assigned transfer-specific activities and coordinating all transfer efforts for product and manufacturing equipment. This position will support and assist in the implementation of new and maintenance of existing automated manufacturing equipment for which they are assigned. They also work with management to improve Technology Transfer Project Management training and assists with training and mentoring peers when needed. They Provides leadership and support to work center and program projects as assigned.

Primary duties include:

• Independently coordinates revisions and release of documentation and cross-functional communication while working within a team.
• Leads projects while applying best practices through project phases. Ensures a project's achievement of quality, scope, and schedule objectives while maintaining regulatory standards, quality system, and manufacturing requirements.
• Leads decisions on scope of work and project timelines and ensures project's success of quality and schedule.
• Schedules meetings, creates agendas, and documents meeting minutes, correspondence, and presentations.
• Represents the Technology Transfer Department by serving as the lead and coordinating with experts to maintain regulatory standards and manufacturing requirements.
• Reports on status of work packages to other department PMs, subject matter experts, Quality Assurance, Supply Chain, and relevant stakeholders.

Training and Education:

• BS or BA in relevant life sciences or engineering fields required
  • Appropriate college level coursework and/or significant related experience may be considered in lieu of degree.
  • Relevant MBA and/or PMP certification from the Project Management Institute desired but not required.

Experience:

• Three or more years of relevant work experience including:
  • FDA 21 CFR, ISO 9001/13485 and/or cGMP/cGLP compliant environment
    • FDA, ISO, or otherwise regulated non-IVD industry experience may be considered
  • Industrialization and sustainment of equipment or IVD consumables or machines
  • Quality Management Systems and Change Control processes
  • Project Management or closely related field