Principal Scientist, Advanced Therapies Characterization

Scorpion Therapeutics; Malvern (Chester County); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks a Principal Scientist, Product Characterization – Advanced Therapies to define comprehensive characterization strategies for cell and gene therapies, including in vivo CAR-T, LNP, mRNA, and lentiviral vectors.

You will establish CQAs using QbD, lead advanced assay development, and develop control strategies that tie process parameters to product quality. Regulatory documentation and cross-functional collaboration are essential to success.

Qualifications

• PhD required in Biochemistry, Immunology, Virology, or related field; 3+ years experience (or 6–8 years with a Bachelor's/Master's)

Responsibilities

• Define product characterization strategies from early to late development.
• Establish and justify CQAs using QbD principles.
• Lead advanced assay development for comparability and deep characterization.
• Develop control strategies linking process parameters to product quality.
• Author regulatory documentation and engage with regulatory agencies.
• Communicate findings to cross-functional teams and stakeholders.
• Foster collaboration with internal departments and external partners.

Education

PhD in Biochemistry/Immunology/Virology

Related field

Job description

Scorpion Therapeutics seeks a Principal Scientist, Product Characterization – Advanced Therapies to define comprehensive characterization strategies for cell and gene therapies, including in vivo CAR-T, LNP, mRNA, and lentiviral vectors.

You will establish CQAs using QbD, lead advanced assay development, and develop control strategies that tie process parameters to product quality. Regulatory documentation and cross-functional collaboration are essential to success.