Develop and maintain comprehensive project plans, including timelines, milestones and resource allocations for the Device, Packaging and Process Development organization.
Coordinate project activities, ensuring alignment with overall project goals and objectives
Monitor progress against plan, identify potential risk and issues, and implement appropriate mitigation strategies.
Effectively communicate ideas, project goals, and results to team members across functions and departments, including device development, packaging, quality, regulatory affairs and manufacturing.
Communicate regularly with key stakeholders, including project sponsors, senior management and external partners or customers.
Identify opportunities for process improvement and optimization.
Initiate and track non-GxP supplier onboarding and follow up with necessary parties, including but not limited to requestor, legal, procurement, and finance to ensure efficient movement throughout entire process
Prepare, process, and support purchase orders and invoices to support a variety of purchasing needs in the organization
Negotiate low complexity contracts with non-GXP service providers to secure preferred terms and services
Required Education, Experience & Skills
A B.S. degree in a technical or scientific field with 5+ years of relevant experience in the pharmaceutical or biotechnology industry.
Strong verbal, written, and interpersonal communication skills are required.
PMP certification is preferred
Medical device or combination product experience is preferred
Ability to effectively collaborate with cross-functional teams and influence key stakeholders.
Must be able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.
Qualified candidates should be self-motivated and organized, knowledgeable of relevant scientific literature, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.
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