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Eden Prairie

    Senior Manager, Manufacturing Cell Production - Eden Prairie, United States - United Therapeutics

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    California, US residents click here.

    The job details are as follows:

    Sr Manager Manufacturing Cell ProductionWhat We DoWe build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun.

    Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases.

    Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

    We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC).

    Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.

    At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

    Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

    With over 100,000 patients on the organ transplant waitlist and only a fraction receiving the lifesaving organ they require, there is a great need for additional sources of transplantable organs.

    At Miromatrix, a leader in regenerative medicine and a subsidiary of United Therapeutics Corporation, we are working to address this unmet need by bioengineering human organs to help save and improve patients' lives.

    Join our team as we continue to make history by developing life-saving therapies to help patients with liver and kidney disease.

    How you'll contributeThe primary job functions and responsibilities of the Senior Manager, Manufacturing Cell Production include effective management of a team of Bioprocess Technicians and general manufacturing management.

    This role will ensure logistics are effectively coordinated, adhere to budgets, and assist in the development and completion of team objectives.

    This position will support general departmental training, order supplies, perform document review and revision, and lead collaborations with the Quality department.

    This position will communicate resource requirements to senior management and ensure that the team is properly trained to carry out general responsibilities.


    The scope of activities for the team include:

    cell isolation of multiple cell types from different human organs or tissues, cell culture, sorting and expansion (including cryo-preservation) of multiple cell lines from different human or animal sources, and performing analytical testing.

    Essential Job Duties & ResponsibilitiesWork with Manufacturing and site leadership to develop objectives for the team and resource requirements to successfully achieve themEnsure quality documentation such as deviations and investigations are completed in a timely manner and that root cause is correctly identifiedServe as a technical expert, train and onboard employees in documentation and process executionBuild, maintain, and motivate the team to ensure achievement of all productivity targets and output requirementsSet expectations for employees, conduct regular performance reviews, mentor, coach, and be responsible for managing the cell isolation team in general termsCommunicate with other departments to ensure alignment of goals and interdependenciesMaintain ordering information and work with Operations and Procurement teamsTrack expenditures for team projectsReview team master batch records, documentation, and data entry, and follow up with the team as needed for completionMonitor and report progress of biomanufacturing operations projects against timelinesImplement process improvements designed to gain efficiencies or increase compliance/safety/ease of useEnsure that the team meets all compliance, OSHA, and GMP requirements and that work is documentedReview and edit experimental plans, SOPs, and MBRs, and submit SOPs and MBRs in compliance with Quality standardsBe responsible for scheduling, process monitoring, and compilation of donor information for analysisCommunicate to and assist VP Manufacturing on projects and initiatives as requiredEnsure cross-functional alignment and communication (R&D, QA, etc.)Ensure supplies are in place for adequate experimental executionMaintain equipment and document maintenance activitiesEnsure the manufacturing area adheres to site requirements for compliance and safetyFor this role you will need Minimum RequirementsBachelor's Degree in biomedical sciences, cell biology, tissue engineering, or related discipline with 10+ years of relevant industry experience; or a Master's Degree in biomedical sciences, cell biology, tissue engineering, or related discipline, with 8+ years of relevant industry experience.2+ years of experience managing and leading teamsTechnical expertise in human cell line cell cultureTechnical expertise in human organ cell isolationExceptional ability to lead, mentor, manage, coach, and motivate team membersKnowledge of good documentation and good manufacturing practicesExcellent written and oral communication skillsPreferred QualificationsKnowledge of kidney and liver biology, physiology, and cell typesAt United Therapeutics you'll realize quickly that it is not an ordinary place to work When you join our company, you will learn, grow, contribute, have fun, and be challenged..

    all while making a difference in the lives of our patients.

    While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness.

    Employees working in customer-facing roles must adhere and comply with customers' credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

    United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities


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