Custom Cell Solutions Program Manager III

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. Were 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 youre 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.

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 MyoSites custom capabilities.

Strong knowledge of project-management tools (e.g. MS Project Smartsheet) and cost-modeling/quotation software.

Exemplifies CookMyoSiteCore 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 inexceptionalrapport with people. Proven success in initiating promoting and maintaining strong interpersonal relations

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

Full Time Remote

While this role is designated as a Remote position bi-weekly onsite attendance is required for important cross-functional team meetings and the achievement of collaborative milestones. The onsite requirements may also include project/program kick off or ad hoc meetings as needed. Efforts will be made to provide sufficient advance notice for onsite meetings and ad-hoc onsite requirements.

Physical Requirements:

Office Setting (with travel): General office warehouse and laboratory setting.

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.

Travel:10-20% Type of Travel: Domestic

Training Compliance:

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.

At Cook MyoSite we dont just accept difference we celebrate it we support it and we thrive on it for the benefit of our employees our products and our community. Cook MyoSite is proud to be an equal opportunity workplace.

This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.