Principal Scientist, Product Characterization – Advanced Therapies

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

Role

Principal Scientist, Product Characterization – Advanced Therapies, focusing on developing comprehensive characterization strategies for cell and gene therapy modalities such as in vivo CAR‑T, LNP, mRNA, and targeted lentiviral vectors.

Responsibilities

Define product characterization strategies from early to late development, establish and justify critical quality attributes (CQAs) using QbD principles, lead advanced assay development for comparability and deep characterization, develop control strategies linking process parameters to product quality, and author regulatory documentation. Engage with regulatory agencies, communicate findings to cross‑functional teams, foster collaboration with internal departments and external partners, stay current with regulatory standards, and contribute to SOP development.

Qualifications

Ph.D. or equivalent in Biochemistry, Immunology, Virology, or related fields with 3+ years (or 6-8 years with Bachelor’s/Master’s).

Experience

Experience required in analytical control strategies for ATMPs, CQA assessment, and assay development for cell and gene therapies.

Skills

Detailed analytical techniques, scientific communication, mentorship, and cross‑functional collaboration.

High‑value biopharma specifics

Focus on advanced therapies (CAR‑T, lentiviral vectors, gene therapy), development stage from early to late, with regulatory and quality oversight.

Work setup

Location flexible among Malvern, PA, Spring House, PA, or Leiden, Netherlands.