Associate Director, Cell Production and Analytical Development

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

Lead efforts to develop, improve, and optimize analytical methods for cell quality and utility for use in a bioengineered tissueLead efforts to develop and optimize analytical methods for bioengineered organ culture related to tissue functionalityAnalyze 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 productsContribute to the development and advancement of group strategies and initiativesManage 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 outcomesAuthor, review, and/or approve study designs and protocolsEnsure that facilities and equipment are qualified to the appropriate level. Assist with the transition of analytics and processes to GMP or GMP-like operations as needed.Assist cell production and process development efforts to optimize cell candidate health and yieldDevelop and qualify analytical and bioanalytical methods for cell and cell-based therapiesPresent and discuss data with laboratory staff, program leaders, and senior management as neededAuthor sections of regulatory filings related to cell candidates and bioengineered organ culture, process development, analytical development and the safety and efficacy of product candidatesManage external relationships (CRO, CMO, academic, industry, government) pertaining to Analytical DevelopmentDirect and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)All other duties as required

For this role you will need

Minimum Requirements

12+ years of post-baccalaureate experience in biology, medicine, physiology, cellular and molecular biology, or biomedical sciences with a Bachelor's Degree or 10+ years of post-baccalaureate experience in biology, medicine, physiology, cellular and molecular biology, or biomedical sciences with a Master's Degree or 8+ years of post-baccalaureate experience in biology, medicine, physiology, cellular and molecular biology, or biomedical sciences with a PhDGood team member skills; must work well with othersGood written and oral communication skillsAbility to initiate and manage day-to-day tasks effectivelyAbility to organize and present dataAbility to independently follow experimental methods and protocolsHighly self-motivatedFacility with appropriate word processing, spreadsheet, presentation and related standard softwareExperience with laboratory instrumentation and data softwareExperience with regulatory requirements for study conductExperience working directly with CROs, CMOs and/or other vendors

Preferred Qualifications

Master’s Degree in a relevant scientific fieldDoctor of Philosophy (PhD) in a relevant scientific field

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