Executive Lead, Downstream Biologics Manufacturing

Avalo Therapeutics, Inc.

Northern (KY)

Hybrid

USD 180,000 - 240,000

Full time

3 days ago

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Benefits offered by this job

Hybrid work model

Competitive compensation

Job summary

Avalo Therapeutics is seeking a Dir./Sr. Director, Downstream Biologics Manufacturing to lead outsourced downstream drug substance manufacturing for late-stage clinical programs and eventual commercial readiness.

The role partners with CDMOs,QA, Regulatory, and Process Development to ensure robust, scalable production of biologics and readiness for regulatory submissions. Ideal candidates will have extensive experience in downstream purification, technology transfer, and PPQ, with a proven track

Qualifications

PhD or MS in a chemical/biochemical engineering discipline.
10+ years in biologics process development, tech ops, or GMP manufacturing.
Experience leading outsourced downstream biologics manufacturing at CDMOs/CMOs.
Strong experience with technology transfer, scale-up, and PPQ.

Responsibilities

Provide technical leadership for downstream drug substance manufacturing for late-stage clinical development and commercial readiness.
Lead evaluation, qualification, governance, and ongoing management of downstream CDMO partners.
Oversee downstream purification processes, including chromatography, viral clearance, filtration, UF/DF, and bulk DS operations.
Review manufacturing readiness, batch records, schedules, and data to ensure successful execution.
Ensure cGMP compliance and regulatory readiness for submissions and inspections.
Collaborate with QA, Regulatory, Process Development, and Supply Chain to mitigate risks.