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Adverum Biotechnologies
Adverum Biotechnologies

Principal Scientist, Downstream Process Development (Contract) - AW

Redwood City, California, U.S.
Contractor
$80 – $90 per hour

TLDR

Develop and optimize downstream processes for AAV gene therapy programs, ensuring regulatory compliance and process scalability while leading purification development and cross-functional projects.

What You’ll Do:
  • Support late‑stage AAV downstream process development and optimization to ensure scalability, robustness, reproducibility, and regulatory compliance.
  • Lead and execute purification development, including chromatography (AFF, IEX) and filtration (depth, NFF, TFF).
  • Individually and partner with other SMEs to author protocols and reports, and execute on process characterization and validation studies (FMEA, scale‑down models, DOE/OFAT, PPQ, hold studies).
  • Compile and analyze process and analytical data in Excel, JMP, or similar software, to identify trends, drive optimization, and lead and support investigations / RCA.
  • Present study findings, issues, and trends to PD and cross-functional CMC teams.
  • Support downstream material generation team as needed to maintain company timelines.
  • Downstream SME to support external manufacturing operations including technical meetings, BPR and related records review, execution, and troubleshooting.
  • Collaborate cross‑functionally (AD, USP, QC, RA) to ensure seamless transition from development to commercial.
  • Provide line leadership if needed.
  • Author/review technical documentation (development reports, SOPs, CMC sections for regulatory filings, Process Monitoring and Control Strategies).
  • Stay updated on industry trends and emerging technologies in gene therapy manufacturing to maintain best-in-class process development practices.
    • About You:
    • Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology, or related field with 6+ years of relevant experience in downstream process development; or M.S. with 8+ years of experience.
    • Proven experience in AAV or other viral vector production, preferably in late-stage development for clinical/commercial scale manufacturing.
    • Strong expertise and in-depth knowledge in functioning and troubleshooting of purification process development/manufacturing equipment such as chromatography and filtration systems.
    • Experience with scalable, AKTA, depth filtration, and TFF systems.
    • Knowledge of GMP requirements and regulatory guidelines for gene therapy products.
    • Prefer to have knowledge of DOE principles, process characterization, and BLA enabling activities.
    • Background in authoring sections of regulatory submissions, including IND, or BLA filings.
    • Excellent problem-solving skills with the ability to troubleshoot and optimize complex bioprocesses.
    • Strong communication and leadership skills to manage cross-functional projects and mentor team members.

    Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

    At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation

    Adverum Biotechnologies
    Adverum Biotechnologies

    Adverum Biotechnologies is a clinical-stage company dedicated to pioneering gene therapy for prevalent ocular diseases, aiming to provide functional cures that restore vision and prevent blindness. Utilizing its proprietary intravitreal platform, Adverum is developing innovative, single-administration treatments to replace the need for frequent ocular injections, transforming the standard of care and addressing significant unmet medical needs in eye health.

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