Senior Process Development Scientist, Cell Therapy (CMC)

Scorpion Therapeutics; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics in Cambridge, MA, seeks a Senior Scientist, Process Development (CMC) to design, lead, and optimize iPSC expansion, differentiation, and scale-up to improve product quality and robustness.

You will collaborate across Analytical Development, drive process characterization, support tech transfer and GMP readiness, author technical reports and CMC documents, mentor junior scientists, and stay current with literature to identify innovation opportunities.

Qualifications

• BS with 10 years (or MS with 10 years, or PhD with 5 years) in cell/developmental biology, tissue engineering, biomaterials, biomedical engineering, or related field.
• 5+ years biotech/pharma industry experience.
• Technical expertise in iPS expansion and differentiation.
• Experience with downstream processing, formulation, and stability (fresh and cryo).
• Experience supporting FDA/other regulatory submissions via technical reports and CMC documentation.
• Ability to mentor; design and perform complex experiments.
• Excellent written/verbal communication.

Responsibilities

• Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes.
• Develop strategies for harvest, downstream processing, formulation, fill-finish, and cryo.
• Lead process characterization studies and support tech transfer and GMP readiness.
• Collaborate with Analytical Development to define CPAs and performance.
• Develop biomaterial-based cell delivery approaches and formulation strategies.
• Prepare technical reports, protocol documents, risk assessments, and CMC documentation.
• Analyze results and provide scientific recommendations.
• Review literature to identify innovation opportunities.
• Maintain compliant records; mentor junior staff.
• Perform other duties as assigned.

Skills

iPSC expansion

Differentiation

Process development

Data analysis

Regulatory submissions support

Education

BS in cell/developmental biology or related field

Tools

PBS bioreactor

Rotea

Biowelder

Metaflex

NC200

Job description

Scorpion Therapeutics in Cambridge, MA, seeks a Senior Scientist, Process Development (CMC) to design, lead, and optimize iPSC expansion, differentiation, and scale-up to improve product quality and robustness.

You will collaborate across Analytical Development, drive process characterization, support tech transfer and GMP readiness, author technical reports and CMC documents, mentor junior scientists, and stay current with literature to identify innovation opportunities.