Manager, Cell Manufacturing - iPSC

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughters pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are Are you an experienced biotech professional ready to lead and inspire a growing team in the exciting field of iPSC-derived cell therapies? Are you ready to dive in with setting up and establishing the production of iPSC cells? The Manager, Cell Manufacturing (iPSC) will lead the establishment and operation of induced Pluripotent Stem Cell manufacturing. This individual will be responsible for hiring and managing the production team, overseeing facility and equipment start-up, day to day production management, and supporting technology transfer from process development. Build and lead a skilled cell manufacturing (iPSC) team, including hiring, onboarding, and mentoring staff Lead and support tech transfer activities for the startup of iPSC production. Engage in and support close collaboration with process development and engineering teams to ensure smooth transfer of processes into production. Supervise day-to-day activities of production team including scheduling and resource planning Monitor raw material usage and maintain accurate inventory levels for production Assist with the implementation and commissioning of new equipment and process changes Support routine equipment troubleshooting and optimization efforts Provide training and development of technical competencies across the team Create, review, and revise SOPs and manufacturing procedures Promote a culture of safety and ensure adherence to all OSHA regulations and company safety policies Initiate and support investigations when process deviations or non-conformances occur Conduct performance evaluations, set objectives, and support career development through coaching, mentoring, and development plans Foster a collaborative and accountable team environment Deliver and document on-the-job training for new and current staff on production processes, equipment, and safety procedures Participate in department and corporate teams and initiatives Perform additional responsibilities as assigned by leadership Minimum Requirements Education and Experience requirements: Bachelors degree in a directly related life science specialty field and 8+ years of related experience in life sciences, or Masters degree in a directly related life science specialty field and 6+ years of related experience in life sciences 2+ years of people management experience Applied knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards. Ability to apply GMP to company specific processes and products Understanding of basic cell therapy techniques, including cell isolation, transduction, and expansion Hands-on experience with cell culture, aseptic technique, and cleanroom operations Familiar with the use and operation of equipment such as biological safety cabinets, balances, pipettes, etc. Identify and perform advanced trouble-shooting and assist with technical issues Excellent professional documentation and verbal communication skills Ability to interact with other departments effectively. Ability to review work performed by other personnel, communicate problems and deficiencies, suggest corrections, and enforce departmental and Company policy and procedures as they relate to manufacturing requirements. Ability to handle confidential company data, projects, information, etc. Proficient with the Microsoft Office Suite Ability to work flexible hours and respond to unplanned manufacturing needs, including potential weekend or off-shift support Comfortable working in a cleanroom or controlled environment Strong interpersonal and leadership skills to effectively lead, mentor and motivate a team Ability to travel internationally (minimal) Preferred Qualifications Masters degree in a directly related life science specialty field 6+ years of experience in operations manufacturing Job Location This is a fully onsite role in our Silver Spring, MD office. This role may require up to 10% domestic and international travel. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. The salary for this position ranges from $120,000 to $150,000 per year. In addition, this role is eligible for the Companys short-term and long-term incentive programs- may not apply to all roles. The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidates experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Companys sole discretion, consistent with the law. Eligible employees may participate in the Companys 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 United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and 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.