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.
Coordinate and execute training activities for both Therapeutic and CCS Production departments. This role focuses on tracking, trending, and scheduling training and retraining events; maintaining accurate role-based training plans and resources; coordinating trainers and trainees; and performing training and qualification assessments, particularly for complex programs such as the aseptic operator training program.
• Coordinate training activities for Therapeutic Production and CCS Production, including initial training, retraining, and periodic refreshers for all applicable roles.
• Maintain accurate, up‑to‑date role‑based training plans and curricula for both production departments, ensuring alignment with current procedures, batch records, and quality system requirements.
• Schedule classroom, OJT, and qualification events and track completion status, overdue items, and upcoming training needs; communicate priorities and timelines to supervisors, leads, managers, and trainers.
• Ensure training courses and resources (SOPs, work instructions, slides, OJT guides, checklists, and assessments) are current, controlled, and aligned with process changes and audit/CAPA outcomes.
• Generate and maintain training metrics and trending reports (e.g., completion rates, overdue training, time‑to‑qualification) for both production departments and share with leadership as requested.
• Serve as the primary point of contact for coordinating trainers and trainees, matching training needs with appropriate trainers, and monitoring progress against training timelines.
• Conduct classroom and OJT training as needed, particularly during periods of high volume or for complex or foundational topics within Therapeutic and CCS Production.
• Observe and rate trainees during signoff and qualification activities, including aseptic operator qualification and other high‑risk operations, and document performance according to defined criteria.
• Support the aseptic operator training program by coordinating training sessions, observing processing on training material, and contributing to qualification readiness decisions.
• Coordinate and support volunteer designated trainers, ensuring assigned training is completed, documentation is accurate, and expectations are understood.
• Periodically observe and critique trainers to assess training technique, adherence to training plans, and consistency; identify and help mitigate training drift or gaps.
• Partner with the central Training department to ensure accurate eQMS records, alignment with corporate training policies, and readiness for internal and external audits related to training.
• 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
• Capable of handling multiple responsibilities and/or projects
• Able to analyze situations or data
• Able to prioritize and operate proactively
Undergraduate degree in any life science or engineering field or 6 years direct, relevant experience in pharmaceutical/ biopharmaceutical manufacturing to provide a comparable background
Experience Preferred: Minimum of 1-3 years' experience in scientific curriculum/learning plan development and/or pharmaceutical/biopharmaceutical manufacturing
Previous experience in a training role
Previous experience with aseptic technique
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
Full-Time On-Site
Physical Requirements:
Laboratory Setting (Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.
• 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 desk, in meetings and/or work on a computer for long or extended periods of time on a regular basis and periodically for up to 3 hours at time.
• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs.
• Must be able to maintain manual acuity for working with computers and equipment. Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) hood, facial mask and appropriate shoes required on a regular basis and for extended periods of time (up to 5 consecutive hours) without exiting the classified area.
• Must be capable of performing PPE gowning procedures, aseptically for up to 5 hours at a minimum of one time per year.
• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.
• Must be able to maintain focus, aseptic qualifications and performance standards of position for extended periods of time without rest periods; periodically at intervals for up to 5 hours at a time.
Employee that does not interact 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 don’t 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.