Senior Scientist, Process Development

United Therapeutics Corporation; Cambridge (MA); On-site; USD 128,000 - 170,000; Full time

Job summary

United Therapeutics Corporation in Cambridge, MA seeks a Senior Scientist, Process Development to design, optimize, and scale iPSC expansion and differentiation for clinical and commercial manufacturing. You will lead development strategies, collaborate across teams for process understanding, and contribute to regulatory documentation.

The role emphasizes mentorship of junior staff, strong scientific communication, and advancing transformative cell therapies in a fast-paced biotech environment.

Qualifications

• Bachelor's degree with 10+ years in cell biology or related field.
• Master's degree with 10+ years in cell biology or related field.
• PhD with 5+ years in cell biology or related field.
• 5+ years of biotech/pharma industry experience.
• Technical expertise in iPS expansion and differentiation process development.
• Experience with regulatory submissions and CMC documentation.

Responsibilities

• Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes to improve robustness and quality.
• Design and execute development strategies for harvest, downstream processing, formulation, fill‑finish, and cryo stabilization for clinical and commercial needs.
• Lead process characterization studies and author technical documentation for technology transfer, process validation, and GMP readiness.
• Collaborate with Analytical Development and other teams to define critical process attributes and advance process understanding.
• Design and conduct complex studies to develop biomaterial-based cell delivery approaches and hold times.
• Contribute to FDA and regulatory submissions by authoring and reviewing technical reports, protocols, risk assessments, and CMC documentation.
• Analyze data and communicate results with project teams and leadership to inform decisions.
• Evaluate literature and technologies to identify opportunities for innovation and continuous improvement.
• Maintain accurate records and mentor junior scientists and research associates.

Skills

Cell biology

Developmental biology

Tissue engineering

Biomaterials

Biomedical engineering

Process development

Regulatory submissions

Mentoring

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

PhD in biology/biomedical engineering or related field

Tools

PBS bioreactor

Rotea

Biowelder

Metaflex

NC200

Job description

California, US residents click here. 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

At Thymmune, you'll join a team pushing the boundaries of cell therapy and transplant innovation through advanced iPSC‑derived manufacturing technologies. As a Senior Scientist, Process Development, you'll play a pivotal role in designing and optimizing processes that support the development of transformative therapies, helping move breakthrough science from concept to clinic. It's an opportunity to solve tough scientific challenges, collaborate with world‑class colleagues, and contribute to a future where more patients have access to life‑changing treatments.

• Design, lead, and optimize iPSC expansion, differentiation, and scale‑up processes to improve process robustness, reproducibility, and product quality
• Design and execute development strategies for harvest, downstream processing, formulation, fill‑finish, and fresh/cryopreservation processes to support clinical and commercial manufacturing needs
• Lead process characterization studies and author technical documentation to support technology transfer, process validation, and GMP manufacturing readiness
• Collaborate cross‑functionally with Analytical Development and other technical teams to define critical process attributes, characterize process performance, and advance process understanding
• Design and conduct complex studies to develop and optimize biomaterial‑based cell delivery approaches, formulation strategies, and clinical in‑use hold times
• Contribute substantively to FDA and other regulatory submissions by authoring and reviewing technical reports, process development summaries, protocols, risk assessments, and CMC documentation supporting product development and clinical advancement
• Analyze, interpret, and communicate experimental results to project teams and leadership, providing scientific recommendations that support program objectives and development decisions
• Evaluate emerging scientific literature, technologies, and industry trends to identify opportunities for innovation and continuous improvement within the process development function
• Maintain accurate and compliant experimental records and provide scientific guidance, technical expertise, and mentorship to junior scientists and research associates
• Perform all other duties as assigned

Minimum Requirements

• A Bachelors Degree with 10 years of relevant experience in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering or related field
• OR a Masters degree with 10 years of relevant experience in in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering or related field
• OR a PHD with 5 years relevant experience in in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering or related field
• 5+ years of biotech/pharma industry experience
• Technical expertise in iPS expansion and differentiation process development
• Technical expertise in downstream processing, formulation and stability of cell based products including fresh and cryo formulation development
• Experience with laboratory instrumentation and data software; with appropriate word processing, spreadsheet, presentation and related standard software
• Experience supporting FDA and/or other regulatory submissions through preparation of technical reports and CMC documentation
• Ability to mentor junior scientists and research associates and provide scientific guidance across projects
• Ability to design and perform complex and technically challenging experiments
• Excellent written, verbal communication and presentation skills

Preferred Qualifications

• Doctor of Philosophy (PhD) or a Master’s Degree in biology, cell biology, biomedical engineering, tissue engineering, developmental biology, or related scientific discipline
• Experience developing biomaterial‑based cell delivery systems, including hydrogels, injectable matrices, scaffolds, extracellular matrix (ECM)-inspired materials, or other implantable biomaterials
• Expertise in automated cell processing equipment such PBS bioreactor, Rotea, Biowelder, Metaflex, NC200, and others
• Experience in tech transfer of cell therapy processes to GMP

Salary range

The salary range for this position is $127,500.00 - $170,000.00 and reflects our good‑faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

Location

This role is based in our Cambridge, MA Thymmune location. 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.

Benefits

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

Equal Opportunity Employer

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.