Manager/Senior Manager, Manufacturing Cell Production

California, US residents click here. The job details are as follows: What We Do We 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 contribute The primary job functions and responsibilities of the Manager include effective management of a team or group of Manufacturing Technicians/Leads and general manufacturing management for the Cell Production Manufacturing process (cell isolation and cell culture). The Manager will ensure logistics are effectively coordinated, budgets are adhered to, and assist in the development and completion of team objectives. The Manager will attend general meetings and communicate information to the team and to the VP of Manufacturing. Any general departmental training, supplies ordering, document review and revision, and leading collaborations with the Quality department would be key tasks for this position. 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 from human organs, cell banking, cell culturing, cryo processes, and performing analytical methods. Work with Manufacturing and site leadership to develop objectives for the team and resource requirements to successfully achieve them Ensure quality documentation such as deviations and investigations are completed in a timely manner and that root cause is correctly identified Serve as a technical expert, train and onboard employees in documentation and process execution Build, maintain, and motivate the team to ensure achievement of all productivity targets and output requirements Set expectations for employees, conduct regular performance reviews, mentor, coach, and be responsible for managing the cell isolation team in general terms Communicate with other departments to ensure alignment of goals and interdependencies Maintain ordering information and work with Operations and Procurement teams Track expenditures for team projects Review team master batch records, documentation, and data entry, and follow up with the team as needed for completion Monitor and report progress of biomanufacturing operations projects against timelines Implement process improvements designed to gain efficiencies or increase compliance/safety/ease of use Ensure that the team meets all compliance, OSHA, and GMP requirements and that work is documented Review and edit experimental plans, SOPs, and MBRs, and submit SOPs and MBRs in compliance with Quality standards Be responsible for scheduling, process monitoring, and compilation of donor information for analysis Communicate to and assist VP Manufacturing on projects and initiatives as required Ensure cross-functional alignment and communication (R&D, QA, etc.) Ensure supplies are in place for adequate experimental execution Ensure the manufacturing area adheres to site requirements for compliance and safety Perform other duties as assigned For this role you will need Minimum Requirements for Manager Bachelor’s Degree biomedical sciences, cell biology, tissue engineering, or related discipline 8 years of relevant industry experience with a Bachelor's degree or 6 years of relevant industry experience with a Master's degree and 2 years of experience managing and leading teams Technical expertise in human cell line cell culture Technical expertise in human organ cell isolation Exceptional ability to lead, mentor, manage, coach, and motivate team members Knowledge of good documentation and good manufacturing practices Excellent written and oral communication skills Minimum Requirements for Senior Manager Bachelor’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 teams Technical expertise in human cell line cell culture Technical expertise in human organ cell isolation Exceptional ability to lead, mentor, manage, coach, and motivate team members Knowledge of good documentation and good manufacturing practices Excellent written and oral communication skills Preferred Qualifications Master’s Degree biomedical sciences, cell biology, tissue engineering, or related discipline Knowledge of kidney and liver biology, physiology, and cell types At 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. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities 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 We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.