Senior Scientist, Process Development

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

Senior Scientist, Process Development (CMC)

Responsibilities:

• Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes to improve robustness, reproducibility, and product quality
• Design and execute development strategies for harvest, downstream processing, formulation, fill-finish, and fresh/cryopreservation for clinical and commercial needs
• Lead process characterization studies and author technical documentation to support technology transfer, process validation, and GMP readiness
• Collaborate cross-functionally with Analytical Development and other teams to define critical process attributes and characterize performance
• Design and conduct studies to develop and optimize biomaterial-based cell delivery approaches, formulation strategies, and clinical in-use hold times
• Author/review technical reports, process development summaries, protocols, risk assessments, and CMC documentation supporting regulatory submissions
• Analyze, interpret, and communicate results; provide scientific recommendations
• Evaluate emerging scientific literature/technologies to identify innovation opportunities
• Maintain accurate, compliant experimental records; mentor junior scientists/research associates
• Perform all other duties as assigned

Minimum Requirements:

• 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
• Technical expertise in downstream processing, formulation, and stability (fresh and cryo)
• Experience with lab instrumentation and data software; standard office software
• Experience supporting FDA/other regulatory submissions via technical reports and CMC documentation
• Ability to mentor; design and perform complex experiments
• Excellent written/verbal communication

Preferred Qualifications:

• PhD or MS in relevant disciplines
• Experience developing biomaterial-based cell delivery systems (e.g., hydrogels, injectable matrices, scaffolds, ECM-inspired materials)
• Expertise in automated cell processing equipment (e.g., PBS bioreactor, Rotea, Biowelder, Metaflex, NC200)
• Experience in tech transfer of cell therapy processes to GMP