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United Therapeutics Senior Manager, Cell Production and Analytical Development in Manchester, New Hampshire

California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

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.

How you’ll contribute

The Senior Manager will manage the development and implementation of analytical methods to evaluate critical quality attributes and in process analytics of cellular material. The Senior Manager will also develop and implement analytical characterization of a bioengineered lung, as needed, to support clinical application.

  • Manage efforts to develop, improve, and optimize analytical methods for cell quality and utility for use in a bioengineered tissue

  • Manage efforts to develop and optimize analytical methods for bioengineered organ culture related to tissue functionality

  • Author, review, and/or approve study designs and protocols

  • Analyze and interpret study data, make insightful scientific conclusions, author and/or review reports, and provide insightful feedback to other teams on study findings to assist with the development of safe and efficacious therapeutic products

  • Manage overall logistics of study conduct, including contract and PO generation, test article production (as needed), study coordination, sample storage and transport, and all other items needed to ensure successful study outcomes

  • Confirm that facilities and equipment are qualified to the appropriate level. Assist with the transition of processes to GMP or GMP-like operations as needed

  • Assist cell production and process development efforts to optimize cell candidate health and yield

  • Develop and qualify analytical and bioanalytical methods for cell and cell-based therapies

  • Present and discuss data with laboratory staff, program leaders, and senior management as needed

  • Contribute to sections of regulatory filings related to cell candidates and bioengineered organ culture, process development, analytical development and the safety and efficacy of product candidates

  • Manage external relationships (CRO, CMO, academic, industry, government) pertaining to Analytical Development

  • Direct and manage team to include responsibilities for goal setting, performance reviews/management, coaching, mentoring and career development

  • Perform all other duties as required

For this role you will need

Minimum Requirements

  • Bachelor’s Degree in a relevant scientific field

  • 10+ years of post-baccalaureate experience in biology, medicine, physiology, cellular and molecular biology, or biomedical sciences with a Bachelor's Degree or

  • 8+ years of post-baccalaureate experience in biology, medicine, physiology, cellular and molecular biology, or biomedical sciences with a Master's Degree or

  • 5+ years of post-baccalaureate experience in biology, medicine, physiology, cellular and molecular biology, or biomedical sciences with a PhD

  • Ability to independently follow experimental methods and protocols

  • Experience with regulatory requirements for study conduct

  • Experience with laboratory instrumentation and data software

  • Experience working directly with CROs, CMOs and/or other vendors

  • Ability to organize and present data

  • Experience with appropriate word processing, spreadsheet, presentation and related standard software

  • Good team member skills with the ability to work well with others

  • Good written and oral communication skills

  • Ability to initiate and manage day-to-day tasks effectively

  • Highly self-motivated

Preferred Qualifications

  • Master’s Degree in a relevant scientific field or

  • Doctor of Philosophy (PhD) in a relevant scientific field or

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.

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