Manager, Cell Manufacturing - iPSC

Manager, Cell Manufacturing (iPSC)

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 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 daughter's 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.

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

Bachelor's degree in a directly related life science specialty field and 8+ years of related experience in life sciences, or

Master's 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

Master's 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 Company's 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 candidate's 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 Company's sole discretion, consistent with the law. 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.

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.