Silver Spring, MD, 20915, USA
15 days ago
Associate Director, Process Development
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:** **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 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. **Who you are** United Therapeutics is seeking a hands-on leader to oversee process development support for a commercially approved monoclonal antibody used in the treatment of high-risk neuroblastoma, a rare and aggressive pediatric cancer. This is an ideal opportunity for someone who values stability and predictability yet is eager to shape the scientific direction of a biologics PD lab. You’ll lead a team of scientists in upstream and downstream process development, method optimization, and technology transfer, collaborating across teams to support both clinical and commercial supply. Experience with regulatory filings is helpful, as this position plays a role in ensuring our processes meet global standards. If you’re driven by purpose, ready to lead with expertise, and passionate about advancing therapies that make a difference, we’d love to connect with you about our **Associate Director, Process Development** role. **For this role you will need** **Minimum Requirements** + Doctor of Philosophy (PhD) in Biochemistry, Biology, Microbiology, or Biotechnology + 7+ years of relevant experience successfully working in the biopharmaceutical industry with proven track record of leadership and success. Relevant experience may include biochemistry pharmaceutics, or related disciplines within pharmaceutical/biotechnology. + 6+ years of experience managing cross functional projects and leading and managing teams + Extensive experience in Upstream and Downstream Process Development and technology transfer of process to manufacturing group and process characterization of biologics, such as mAbs + Experience in technology transfer and experience working with late and commercial stage biologics, with experience in process development, process characterization + Experienced in people and stakeholder management, conflict resolution, and building consensus + Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams + Strong communications skills: oral, written and electronic + The ability to work independently or in a team environment + Self-directed and creative and must be able to work effectively in a flexible and multi-disciplinary team environment + Analytical skills required to interpret and summarize (scientific data) and information + Planning skills required to organize, prioritize, schedule and coordinate work activities for multiple projects **Preferred Qualifications** + Good understanding of cGMP-regulations including relevant US/EU regulatory and quality requirements, practices, and standards is preferred + Experience working with Contract Manufacturers + Knowledge of experimental design and statistical methods **Job Location** United Therapeutics requires this candidate to be 100% on-site at our Silver Spring, Maryland location. This position may require up to 5% travel for seminars, vendor visits, or partner visits. 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 $159,000 to $190,000 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. 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._
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