Senior Scientist, Process Development

Unither Pharmaceuticals; Cambridge (MA); On-site; USD 128,000 - 170,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401(k) plan and ESPP

Paid time off

Job summary

United Therapeutics, Cambridge, MA, seeks a Senior Scientist, Process Development (CMC) to design and optimize iPSC-derived thymic epithelial progenitor cell processes. You will lead expansion, differentiation, scale-up, and downstream steps to ensure robust, high-quality cell therapies for clinical and commercial use.

You will collaborate across teams to define critical attributes, contribute to regulatory documentation, and mentor junior scientists while advancing scalable manufacturing.

Qualifications

• BS/BA with 10+ years in cell biology or related field, or MS with 10+ years, or PhD with 5+ years.
• 5+ years of biotech/pharma industry experience.
• Experience in iPS expansion and differentiation process development.
• Experience in downstream processing, formulation and stability of cell-based products.
• Experience supporting FDA/CMC submissions through technical reports.
• Ability to mentor junior scientists and lead complex experiments.
• Excellent written, verbal, and presentation skills.

Responsibilities

• Lead iPSC expansion, differentiation, and scale-up to improve process robustness and product quality.
• Develop harvest, downstream processing, formulation, fill-finish, and cryopreservation for clinical and commercial needs.
• Lead process characterization and support technology transfer and GMP readiness.
• Collaborate with Analytical Development to define critical process attributes and performance.
• Design studies to optimize delivery formulations and clinical hold times.
• Contribute to regulatory submissions with technical reports and CMC documents.
• Communicate results to teams and leadership and guide project decisions.
• Explore literature and industry trends to drive continuous improvement.
• Mentor junior staff and maintain compliant records.

Skills

iPSC expansion

differentiation

downstream processing

formulation & stability

FDA/CMC documentation

team mentorship

experimental design

data interpretation

regulatory submissions

communication skills

Education

PhD in biology/biomedical engineering

MS in biology/biomedical engineering

Related field Doctoral level (PhD)

Tools

PBS bioreactor

Rotea system

Biowelder

Metaflex

Job description

California, US residents

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.

Thymmune, a United Therapeutics subsidiary is a biotechnology company developing a machine learning-driven thymic cell engineering platform to restore normal immune function in aging and disease. The company’s cutting-edge approach in iPSC-thymic cell manufacturing can generate off-the-shelf cells at scale. The company is developing a pipeline of therapies to treat immunodeficiencies, transplant related, and autoimmune diseases.

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

The Senior Scientist, Process Development (CMC) will plan, conduct, and support process development activities for an iPSC-derived thymic epithelial progenitor cell process. Activities include scale-up, expansion, differentiation (2D and 3D), harvest, wash, formulation and stability to ensure process reproducibility and robustness.

• 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

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.

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.