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Principal Scientist – Downstream Process Development
Adverum BiotechnologiesPrincipal Scientist developing downstream processes for AAV gene therapy at Adverum. Optimizing practices and ensuring smooth transitions to GMP-compliant manufacturing.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Adverum Biotechnologies Website LinkedIn All Job Openings 51 - 200 employees Founded 2013 🧬 Biotechnology 💊 Pharmaceuticals 💰 $217M Post-IPO Equity on 2020-08 Biotechnology
- Pharmaceuticals Adverum Biotechnologies is a company focused on developing gene therapies to treat debilitating ocular diseases. Their mission is to establish gene therapy as a new standard of care, particularly in treating conditions like wet age-related macular degeneration (wet AMD), which is a leading cause of blindness globally. The company is advancing their investigational gene therapy Ixo-vec, designed to provide a long-lasting treatment through a single in-office administration, which could replace the current standard of frequent and painful eye injections. By leveraging their proprietary adeno-associated virus (AAV) vector platform, Adverum aims to transform the standard of care, improve accessibility to treatment, and achieve significant societal impact by restoring vision and preventing blindness. Principal Scientist – Downstream Process Development 🔥 21 minutes ago 🏢🏡 Redwood City – Hybrid 💵 $80 - $90 / hour ⏳ Contract/Temporary 🔴 Lead 🧬 Research Scientist 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume for this job Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- 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. 🎯 Requirements
- 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. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs
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Hard Skills & Tools
AAV downstream process developmentpurification developmentchromatographyfiltrationprocess characterizationvalidation studiesdata analysistroubleshootingregulatory complianceGMP requirements
Soft Skills
problem-solvingcommunicationleadershipcollaborationmentoring
Certifications
Ph.D. in BiochemistryPh.D. in Chemical EngineeringPh.D. in Molecular BiologyM.S. in related field