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Downstream Purification Lead Jobs (NOW HIRING)

Actalent

GMP Lead (Downstream)

Grove City, OH · On-site

$93K - $100K/yr

Lead downstream operations for the purification of viral-based vectors related to gene therapy GMP in a cleanroom environment. * Plan and manage downstream activities, process optimization, and ...

Actalent

GMP Lead (Downstream)

Grove City, OH · On-site

$93K - $100K/yr

Lead downstream operations for the purification of viral-based vectors related to gene therapy GMP in a cleanroom environment. * Plan and manage downstream activities, process optimization, and ...

Biogen

NC · On-site

$31.25 - $40.87/hr

This role's primary focus is Downstream (Purification): * Column Chromatography * Viral Filtration ... Actively participate and lead in training and development initiatives, both for personal growth and ...

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How much do downstream purification lead jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for downstream purification lead in the United States is $26.43, according to ZipRecruiter salary data. Most workers in this role earn between $18.99 and $31.01 per hour, depending on experience, location, and employer.

What does a downstream purification lead do?

A Downstream Purification Lead oversees the purification processes in biopharmaceutical manufacturing, ensuring that proteins or other biological products are efficiently separated and purified after initial production. They manage teams, troubleshoot process issues, implement improvements, and ensure compliance with industry regulations and quality standards. Their role is critical for delivering high-purity products for clinical or commercial use, and they often collaborate with upstream production, quality control, and regulatory teams.

What are the key skills and qualifications needed to thrive as a downstream purification lead?

To thrive as a Downstream Purification Lead, you need expertise in bioprocess engineering, protein purification techniques, and a relevant degree in biotechnology, biochemistry, or a related field. Familiarity with chromatography systems, filtration technologies, and regulatory compliance (such as GMP) is crucial, along with experience using laboratory information management systems (LIMS). Strong leadership, problem-solving abilities, and effective communication help manage teams and resolve process challenges efficiently. These skills are vital to ensure high-yield, high-purity product output while maintaining safety and compliance in biomanufacturing environments.

What are some common challenges faced by a downstream purification lead, and how can they be addressed?

A Downstream Purification Lead often faces challenges such as maintaining process consistency, troubleshooting equipment issues, and ensuring product quality under tight timelines. Balancing multiple projects and adapting to evolving regulatory requirements can also be demanding. Effective solutions include rigorous documentation, proactive communication with upstream and analytical teams, and ongoing training in emerging purification technologies. Building strong cross-functional relationships and fostering a culture of continuous improvement can help navigate these complexities successfully.

What are popular job titles related to Downstream Purification Lead jobs?

For Downstream Purification Lead jobs, the most frequently searched job titles are:

Infographic showing various Downstream Purification Lead job openings in the United States as of September 2026, with employment types broken down into 88% Full Time, 10% Part Time, and 2% Contract. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution, with an average salary of $54,972 per year, or $26.4 per hour.

Director, Downstream Process Development and Manufacturing Biologics

Bridgewater, MA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

Other

Posted 15 days ago

Job description

About The Role

Director, Downstream Process Development and Manufacturing Biologics (Technical Operations CMC) reporting to the Executive Director, Pharmaceutical Development.

What You'll Do
  • Lead end-to-end downstream process development across unit operations, including viral clearance, process characterization (QbD), process validation, and BLA-enabling activities for clinical/commercial manufacturing.
  • Develop and implement phase-appropriate downstream purification strategies for early/late-stage pipeline projects.
  • Direct development and transfer of processes to Contract Manufacturing Organizations (CMOs); oversee scale-up to pilot/GMP commercial production.
  • Provide technical oversight and direction to CDMO partners to ensure robust, scalable, compliant manufacturing.
  • Define and oversee viral safety strategies (viral inactivation, viral filtration (VF), chromatography-based clearance).
  • Supervise development of filtration (VF, UFDF) and chromatography steps; implement QbD for characterization and validation.
  • Stay current on emerging downstream process technologies.
  • Author/review technical documents including BLA filings, CMC sections, and viral clearance studies.
  • Coach, mentor, and provide technical guidance.
  • Collaborate cross-functionally to align technical strategies with organizational/business objectives.
Who You Are (Qualifications)
  • PhD with at least 5 years industry experience, or MS with at least 8 years industry experience.
  • Downstream process development and manufacturing of biologics (antibodies, ADC, fusion proteins).
  • Deep experience with chromatography systems, filtration, viral inactivation/removal, and CDMO management.
  • Experience/knowledge in process characterization and process validation.
  • Extensive understanding of cGMP regulations and ICH guidelines.
  • Ability to work collaboratively using diverse perspectives.
Nice to Have
  • Degree in Chemical Engineering, Biotechnology, or relevant scientific field.
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