Director, Biologics Analytics – Phase 3 & Regulatory

Scorpion Therapeutics

Chesterbrook (PA)

Hybrid

USD 180,000 - 280,000

Full time

3 days ago

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Job summary

Scorpion Therapeutics seeks a Director of Analytical Development to lead late-stage biologics programs, focusing on Phase 3 clinical supply, process characterization, validation, and regulatory submissions. You will oversee external CROs/CDMOs and ensure analytical strategies support product quality and regulatory compliance.

Lead investigations, collaborate with Manufacturing, Quality, Regulatory and Supply Chain, and guide data-driven decisions for commercialization.

Qualifications

PhD/MS/BS in relevant sciences.
10+ years in biopharma analytical development, especially biologics.
Experience supporting late-stage development, regulatory filings (BLA/MAA), and commercialization.
Expertise in chromatographic, electrophoretic, MS, and potency assays.
Proven external partner management and regulatory documentation skills.

Responsibilities

Provide strategic leadership for analytical methods development, validation, transfer, characterization, stability, and control strategies.
Oversee external CROs/CDMOs and ensure alignment with program milestones.
Ensure analytical approaches support product quality attributes and regulatory compliance.
Lead investigations of analytical issues to drive CAPA and quality improvements.
Collaborate cross-functionally with Manufacturing, Quality, Regulatory, and Supply Chain to mitigate risks.