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The job details are as follows:

Manager/Sr Manager, R & D Cell Production

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 Manager/Sr Manager, R&D Cell Production will oversee process development and implementation of large-scale cell culture processes to supply R&D with primary cell types of interest for organ recellularization activities. This role works collaboratively with Upstream R&D to define new processes and process improvements, with the full R&D department in identifying cell culture needs, scheduling required work activities, and delivering requested cells, and with Manufacturing on transferring final processes in anticipation of clinical use.

Essential Job Duties & Responsibilities

Manager role:

• Manage a team of R&D Technicians to perform large-scale cell production in support of R&D recellularization and development activities

• Manage personnel, equipment, and material schedules and logistics related to critical cell culture activities

• Perform process development efforts to refine and optimize GMP or GMP-like large-scale cell production methods and processes

• Collaborate in the development, qualification, and implementation of analytical methods for testing cellular materials

• Support definition of critical quality attributes and monitor the quality of cellular material

• Ensure R&D Cell Culture facilities and equipment are qualified to the appropriate level

• Help develop and streamline cell culture protocols for clinically relevant scale

• Support change management in transferring each process to manufacturing with appropriate SOPs and supporting documentation as part of tech transfer

• Present and discuss data and technical information with team members, peers, and department leadership

• Provide scientific input for and authors relevant sections of regulatory filings related to cell culture methods, process characterization data, and the safety and efficacy of produced cellular material

• Direct and manage team members, including hiring, training, goal setting, performance management, coaching, mentoring, and career development

In addition, the Sr Manager Job Duties & Responsibilities would include:

• Lead process development efforts to refine and optimize GMP or GMP-like large-scale cell production methods and processes

• Define the qualification strategy for analytical methods needed for testing cellular materials

• Set strategy for defining critical quality attributes and establish workflow for monitoring quality of cellular material

• Provide ownership of R&D Cell Culture facilities and equipment and establish policies and procedures to ensure appropriate levels of qualification

• Lead development and optimization of cell culture protocols for clinically relevant scale

• Actively drive change management in transferring each process to manufacturing with appropriate SOPs and supporting documentation as part of tech transfer

• Present and discuss data and technical information with team members, department leadership, and senior management as needed

• Set strategy and provides scientific input for relevant sections of regulatory filings related to cell culture methods, process characterization data, and the safety and efficacy of produced cellular material

For this role you will need

Manager role:

Minimum Requirements

• Bachelor’s Degree in biomedical sciences, cell biology, tissue engineering, or related discipline

• 8+ relevant industry experience including cell culture, large scale cell manufacturing, pilot plant operations, tissue engineering with a Bachelor's Degree

• 6+ relevant industry experience including cell culture, large scale cell manufacturing, pilot plant operations, tissue engineering with a Master’s Degree

• 2+ relevant industry experience including cell culture, large scale cell manufacturing, pilot plant operations, tissue engineering with a PhD

• 2+ experience with QMS in a cGMP environment within an FDA regulated industry

• Exceptional ability to lead, mentor, manage, coach, and motivate team members

• Technical expertise in primary cell culture methods

• Skilled at managing the complex details, schedule, and logistics for support large scale cell culture

• Knowledge of good documentation and good manufacturing practices

Sr Manager role:

Minimum Requirements:

• Bachelor’s Degree in biomedical sciences, cell biology, tissue engineering, or related discipline

• 10+ years of relevant industry experience including cell culture, large scale cell manufacturing, pilot plant operations, tissue engineering with a Bachelor's Degree

• 8+ years of relevant industry experience including cell culture, large scale cell manufacturing, pilot plant operations, tissue engineering with a Master’s Degree

• 5+ years of relevant industry experience including cell culture, large scale cell manufacturing, pilot plant operations, tissue engineering with a PhD

• 5+ years of experience with QMS in a cGMP environment within an FDA regulated industry

• Exceptional ability to lead, mentor, manage, coach, and motivate team members

• Technical expertise in primary cell culture methods

• Skilled at managing the complex details, schedule, and logistics for support large scale cell culture

• Knowledge of good documentation and good manufacturing practices

Preferred Qualifications

• Master’s Degree in biomedical sciences, cell biology, tissue engineering, or related discipline or

• Doctor of Philosophy (PhD) in 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.

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.