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Position Overview:
Develop scalable cell culture and exosome purification processes to improve production of regenerative medicine products.
Key Accountabilities / Responsibilities:
- Lead efforts in upstream bioprocess development, with particular focus on the efficient expansion of adherent and non-adherent cells (e.g. stem cells, adult primary cells) in cell culture bioreactors
- Conduct insightful studies to improve the yield (biogenesis) and/or potency of therapeutically-relevant exosomes
- Fully interrogate cell signaling pathways to understand the effects of cell culture conditions on mechanistic attributes
- Implement cell culture and purification strategies to ‘customize’ exosome products for targeted clinical indications
- Lead cell line development activities for the purpose of producing therapeutically-relevant exosomes
- Lead technical development activities for next-generation exosome products
- Support efforts in downstream bioprocess development, focusing on methods for cell harvest from bioreactors and isolation of exosomes from cell culture supernatant
- Support efforts to identify chromatographic (affinity, ion-exchange) methods for the purification of exosomes, with a focus on scalable manufacturing methods
- Complete bioprocess workflows for exosome-based products. Identify process gaps, and develop in-process and end-of-process analytical methods for evaluating product quality
- Participate in tech transfer of methods to external research or manufacturing organizations as needed
- Author, review, and/or approve protocols for the production of cell and cell-based materials
- Author and/or review scientific manuscripts and regulatory submissions
- Regularly present and discuss data with laboratory staff, program leaders, and senior management as needed
- Manage external relationships (CRO, CMO, academic, industry, government) pertaining to product R&D
- Indirectly manage small teams (2-4 staff members) for product development, including proof-of-concept experiments, scale-up studies, and production runs
- Frequent interactions with laboratory personnel and program leaders in Regenerative Medicine. Additional interactions with Facilities, Regulatory, Quality and other internal departments on an as-needed basis
Minimum Requirements:
- PhD in Cell/Molecular Biology, Biomedical Engineering, Biomanufacturing or related field with 2-5 years of relevant academic or post-graduate experience.
- Master’s or Bachelor’s Degree in Cell/Molecular Biology, Biotechnology, Biomedical Engineering, Biomanufacturing or related field with 5-10 years of relevant experience
- 1-5 years of industry or academic experience in the development of biologics (cells, or cell-derived products) for therapeutic use
- 1-5 years of experience with operating cell culture bioreactors and/or chromatography systems
- Stem or progenitor cell culture, flow cytometry, and molecular biology experience a plus
Preferred Knowledge, Skills, and Abilities:
- Stem or progenitor cell culture, flow cytometry, and molecular biology experience a plus
- Excellent organizational skills with great attention to detail and quality of work
- Ability to problem-solve in a creative and effective manner
- Good team member skills; must work well with others
- Good written and oral communication skills
- Ability to initiate and manage day-to-day tasks effectively, including multi-tasking, flexibility and adaptability
- Ability to organize and present data
- Ability to independently follow experimental methods and protocols
- Highly self-motivated
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer – EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
