Director Analytical Development

Avalo Therapeutics; Chesterbrook (PA); On-site; USD 180,000 - 280,000; Full time

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.

Skills

External partner management

Regulatory documentation

Cross-functional collaboration

Regulatory filings (BLA/MAA)

Education

PhD/MS/BS in relevant sciences

Tools

Chromatography

Electrophoresis

Mass spectrometry

Biological potency assays

Job description

Role: Director of Analytical Development leading late-stage biologics programs, with a focus on supporting Phase 3 clinical supply, process characterization, validation, regulatory submissions, and commercial readiness.

Responsibilities

• provide strategic leadership for analytical methods development, validation, transfer, characterization, stability, and control strategies;
• oversee external CROs/CDMOs;
• ensure analytical approaches support product quality attributes, comparability, and regulatory compliance;
• lead investigations of analytical issues;
• collaborate cross-functionally with Manufacturing, Quality, Regulatory, and Supply Chain to mitigate risks and meet program milestones.

Requirements

• Ph.D., M.S., or B.S. in relevant sciences;
• 10+ years in biopharma analytical development, especially with biologics such as monoclonal antibodies or recombinant proteins;
• extensive experience supporting late-stage development, regulatory filings (BLA/MAA), and commercialization;
• strong expertise in chromatographic, electrophoretic, mass spectrometry, and biological potency assays;
• proven external partner management and regulatory documentation skills.

HighValue: biologics (mAbs, proteins), Phase 3, regulatory submissions, cGMP, analytical lifecycle management, stability, comparability, and process validation; experience with global CRO/CDMO oversight; travel up to 30%.

WorkSetup: hybrid Chesterbrook, PA; minimum 2 days/week onsite.