Custom Cell Solutions Program Manager III

Role Overview

• Receive and triage external inquiries for custom tissue or cell-based services; facilitate discovery calls to clarify scientific and technical requirements.
• Coordinate cross-functional scoping discussions to define deliverables, milestones, resource needs, timelines, and risk-mitigation strategies with senior oversight.
• Develop and maintain detailed work-breakdown structures, responsibility matrices, and integrated timelines.
• Support Finance and Supply Chain with cost input; assist in preparing quotations, Statements of Work (SOWs) and Master Service Agreements (MSAs.)
• Serve as project manager from contract signature through project close-out for tissue acquisition, processing, cell isolation/culture, and analytical/testing activities. Track scope, schedule, budget, and quality metrics; conduct routine internal and external status meetings and publish action logs.
• Escalate program risks, issues, or changes to scope in collaboration with senior program leadership, Quality, and Regulatory teams.
• Ensure all program documentation complies with Cook MyoSite Quality System, cGMP/GLP, 21 CFR Part 11, and other applicable regulations.
• Serve as day-to-day point of contact to sponsors, tissue procurement organizations, CRO/CMO partners, and academic collaborators, escalating strategic or commercial matters as needed.
• Prepare clear, audience-appropriate communications and executive dashboards, summarizing financial performance, milestone status, and key risks.
• Cultivate long-term relationships that lead to repeat business and expanded service offerings.
• Analyze program data to recommend process improvements, pricing refinements, and new service-line opportunities.
• Contribute to continuous improvement efforts by identifying process inefficiencies and pricing refinements and identifying new service-line opportunities.
• Support preparation of marketing collateral, case studies, and conference presentations highlighting Cook MyoSite’s custom capabilities.

Requirements

• Undergraduate degree in Business or Life Sciences or 5 years direct, relevant experience in specialty healthcare distribution to provide a comparable background
• Minimum of 3+ years' experience in pharmaceutical or biotechnology industries
• MBA or MPH preferred
• Prior experience in project and program management preferred
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing.
• Must be able to multitask
• Must be able to efficiently manage travel plans and promptly submit accurate expense reports
• Must be able to effectively build and manage budgets

Benefits

• Employee that interacts with Healthcare Professional: In addition to below, Compliance with Cook Policy & Guidance On Interaction with Healthcare Professionals.
• Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.