Downstream Biologics Manufacturing Lead

Avalo Therapeutics

Chesterbrook (PA)

Hybrid

USD 180,000 - 280,000

Full time

13 days ago

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Job summary

Avalo Therapeutics in Chesterbrook, PA is seeking a Dir./Sr. Director for Downstream Biologics Manufacturing.

You will lead outsourced downstream manufacturing programs, drive process characterization, and ensure regulatory readiness for late-stage/bulk drug substance production. You will collaborate with CDMOs, QA, Regulatory, and Process Development to ensure scalable, compliant manufacturing toward commercial readiness.

Qualifications

Doctoral, Master's, or Bachelor's degree in a relevant engineering/science field required.
Typically 10+ years in biopharmaceuticals with late-stage development experience.
Experience leading outsourced downstream biologics manufacturing at CDMOs is essential.
Proven track record in technology transfer and scale-up for commercial readiness.

Responsibilities

Provide technical leadership for downstream drug substance manufacturing across phases, focused on late-stage development.
Lead CDMO governance, selection, and ongoing performance management for downstream manufacturing.
Oversee purification, chromatography, viral inactivation/clearance, UF/DF, and related operations.
Review batch records, deviations, and investigations; drive CAPAs and continuous improvement.
Ensure cGMP compliance and regulatory readiness for IND/IMPD/MAA/CMC content.