Principal Scientist, Early Development ADSI Lead

Johnson & Johnson Innovative Medicine; Malvern (Chester County); On-site; USD 140,000 - 180,000; Full time

Job summary

Johnson & Johnson Innovative Medicine R&D in Malvern, PA, seeks a Principal Scientist, Early Development Analytical Development ADSI to lead analytical strategy and direct a cross-functional scientific team across AD sub-functions.

You will be accountable for delivering high-quality regulatory documents and shaping programs from discovery to development while ensuring scientific rigor and strategic alignment.

Qualifications

• Master's or PhD in analytical science required; PhD preferred.
• At least 6 years (MS) or 3 years (PhD) in biopharmaceutical development.
• 2+ years cross-functional CMC or analytical sub-team experience preferred.
• Knowledge of analytical strategies, protein characterization, and potency assays.
• Experience authoring CMC sections of INDs/IMPDs and health authority responses.
• Excellent communication, leadership, and matrix collaboration skills.

Responsibilities

• Provide strategic and technical leadership in analytical development and lead a cross-functional team.
• Represent Analytical Development on the CMC team and deliver project outcomes.
• Lead CQA assessment, analytical control strategy, and product specifications.
• Lead analytical reviews at governance meetings with SMEs.
• Ensure complete, consistent, high-quality regulatory documents to health authorities and report status to senior management.
• Manage project risk with mitigation strategies and escalation as needed.
• Collaborate with Manufacturing, Regulatory, Quality, Discovery, and external partners.

Skills

Analytical Chemistry

Biochemistry

Biopharmaceutical development

Cross-functional collaboration

Leadership

Regulatory communication

Matrix environment

Analytical characterization

Education

Master’s degree in Analytical Chemistry

Ph.D. in Analytical Chemistry

Tools

Analytical instrumentation

Job description

Johnson & Johnson Innovative Medicine R&D in Malvern, PA, seeks a Principal Scientist, Early Development Analytical Development ADSI to lead analytical strategy and direct a cross-functional scientific team across AD sub-functions.

You will be accountable for delivering high-quality regulatory documents and shaping programs from discovery to development while ensuring scientific rigor and strategic alignment.