Custom Cell Solutions Program Manager III

Cook Group • Pittsburgh, PA

11d • Remote

About The Position

Overview Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply. The Custom Cell Solutions Program Manager III supports the scoping, pricing, contracting, and execution of external programs involving tissue acquisition, tissue processing, cell isolation, cell culturing, analytical development, and testing services. This role coordinates cross-functional collaboration to help translate customer requirements into clear, compliant statements of work and to support project delivery in alignment with timelines, budgets, and quality standards.

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
• 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
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at a desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.

Nice To Haves

• MBA or MPH preferred
• Prior experience in project and program management preferred

Responsibilities

• 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.
• Strong knowledge of project-management tools (e.g., MS Project, Smartsheet) and cost-modeling/quotation software.
• Exemplifies Cook MyoSite Core Values
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• This position requires an ongoing commitment to upgrading knowledge, job skills, and abilities in addition to competency related to all duties and responsibilities listed above.
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Trainability
• Must have effective verbal, written and interpersonal skills
• Able to prioritize and operate proactively
• Must demonstrate critical thinking and proven problem-solving skills
• Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level