Job Responsibilities • 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.