Product Transfer Manager- HYBRID

Description

Primary Duties: 

• Perform all work in compliance with company policy and within the guidelines of its Quality System.
• Provides transfer resources to projects.
• Uses program/project management techniques to assign all work and projects to Technology Transfer Project Managers and Project Coordinators.
• Establishes and tracks metrics for transfer processes to enable consistent and appropriate project timelines.
• Maintains and updates Technology Transfer work instruction documents and processes as needed to streamline efforts and maintain quality.
• Leads weekly group and individual status meetings.
• Works with program and portfolio leaders when assessing a project’s resource needs and provides estimates on resource availability and preliminary transfer timeline.
• Will review project risks, identify bottlenecks/issues, and work with Technology Transfer Project Managers to ensure quality and timelines are met for all product transfers when needed.
• Directly supervises staff including hiring, orienting, onboarding, and training.
• Participates in work performance appraisals, performance improvement plans, corrective actions, and terminations.
• Work collaboratively with direct reports to create employee development plans.
• Reviews staffing and request hires as needed.
• Responsible for timesheet approval, PTO approvals, and attendance tracking.
• Participates in management training.
• New and/or currently undefined company needs that can be fulfilled by the Product Transfer Manager may be required.

Education and Experience:

• BS in relevant life sciences or engineering field required.
  • Appropriate college level coursework and/or significant related experience may be considered in lieu of degree.
• Relevant MBA/advanced degree and/or PMP certification from the Project Management Institute is desired but not required.
• Six or more years’ relevant experience including:
  • FDA 21CFR 820, ISO 9001/13485 and/or cGMP/cGLP compliant environment
  • FDA or ISO regulated, non-IVD industry experience may be considered
  • Industrialization and sustainment of IVD products and/or manufacturing equipment and processes
  • Quality Management Systems and Change Control processes
  • Project management or closely related field
• 2-5 years direct report management and development
  • Significant, relevant leadership experience may be considered in lieu of direct report management experience.

Required:

• Ability to fully understand the Technology Transfer Project Manager and Coordinator positions, their roles, and their responsibilities.
• Proficiency in MS Office Suite including Project, Timeline, and flowchart applications.
• Strong leadership and decision-making ability.
• Ability to work collaborative with leaders in other departments to drive towards decisions that support company objectives and follow established processes.
• Strong documentation practices, planning, and organization skills.
• Strong verbal and written communication skills.
• Excellent interpersonal skills with the ability to engage employees and provide timely/consistent feedback.
• Ability to effectively prioritize and make decisions in a fast-paced environment.

Preferred:

• Familiarity with the following software packages: Solidworks, Perforce, Arena, SAP, Asana, Office 365