Scientist Downstream Purification

Position Overview

The Scientist in Downstream Purification will spearhead the development, enhancement, and technology handover of downstream purification processes to support vaccines, monoclonal antibodies (mAbs), recombinant proteins, virus-like particles (VLPs), and other biologics for discovery, preclinical, and clinical phases. This role primarily supports NIH programs by establishing robust, scalable, and GMP-aligned purification methods for clinical candidate production. The scientist will work closely with cross-functional teams to propel clinical initiatives, provide expertise in downstream processing, and drive technical innovations via process improvement.

Primary Duties

• Lead design, development, optimization, and scale-up of purification procedures for biologics including vaccines and mAbs targeting preclinical and clinical development phases.
• Utilize chromatography, filtration, and ultrafiltration/diafiltration (UF/DF) techniques to meet product quality, purity, yield, and process consistency benchmarks.
• Organize and conduct downstream process development efforts advancing clinical candidate status and GMP manufacturing compliance.
• Apply Design of Experiments (DOE) and statistical tools such as JMP for process characterization and improvements.
• Create scalable purification workflows that support toxicology, clinical manufacturing, and commercial advancement.
• Direct technology transfer of purification processes to GMP production and provide support throughout manufacturing campaigns.
• Develop and approve technical documentation including process flow diagrams, batch records, and transfer documents.
• Act as Subject Matter Expert for downstream purification during manufacturing, troubleshooting, facility analysis, and process investigations.
• Manage viral clearance strategies including validation studies coordination, CRO evaluations, method approvals, and documentation review.
• Collaborate with teams from Manufacturing, Process Sciences, QA, QC, Regulatory Affairs, and Project Management to ensure milestone achievement and manufacturing goals.
• Support regulatory filings by preparing Chemistry, Manufacturing, and Controls (CMC) documentation for Investigational New Drug (IND) submissions and responding to regulatory questions.
• Analyze and present scientific data through reports, presentations, summaries, and peer-reviewed publications.
• Resolve downstream processing issues and implement modifications to boost product recovery and process efficiency.
• Supervise downstream process execution for toxicology lot production including protocol reviews and final reporting.
• Mentor junior scientists and laboratory staff in best practices, techniques, and equipment usage.
• Maintain comprehensive documentation aligned with GDP, GLP, and GMP standards.
• Innovate purification technologies and disseminate scientific achievements at conferences and publications.
• Provide strategic scientific guidance for purification approaches supporting new biologics development programs.

Required Qualifications

• Ph.D. in Bioengineering, Chemical Engineering, Biochemistry, Biotechnology, Molecular Biology, or related life science field.
• At least eight years of industry experience in downstream purification process development for recombinant proteins, monoclonal antibodies, vaccines, or biologics in GMP clinical-stage manufacturing environments.
• Deep expertise in chromatography, filtration, UF/DF, viral clearance, scale-up, and technology transfer to GMP manufacturing.
• Strong understanding of bioprocess development, process characterization, validation, and clinical manufacturing operations.
• Experience preparing regulatory submissions, especially IND CMC documentation and regulatory interaction.
• Proficiency with DOE and data analysis software such as JMP.
• Comprehensive knowledge of GMP, GLP, GDP, and regulatory compliance.
• Proven ability to troubleshoot complex purification challenges and devise data-supported solutions.
• Effective leadership of multidisciplinary project teams and collaboration with scientific and manufacturing groups.
• Excellent skills in scientific writing, technical documentation, verbal communication, and presentations.
• Experience mentoring junior scientists and fostering collaborative research environments.
• Strong organizational skills for managing multiple priorities and meeting timelines.
• Dedication to maintaining methodical, well-organized scientific records.

Compensation and Benefits

Annual salary ranges from $135,000 to $150,000. The benefits package includes:

• Medical plans through three Blue Cross Blue Shield options.
• Dental and vision insurance via Guardian.
• Generous paid time off including federal holidays.
• 401(k) retirement plan with employer Safe Harbor matching, Roth option, automatic enrollment (optional), and rollover capability.
• Basic Life and Accidental Death and Dismemberment Insurance by Guardian.
• Short-term and long-term disability coverage.
• Health Savings Account (HSA) and Flexible Spending Account (FSA) with employer contributions.
• Biweekly paychecks and user-friendly payroll/benefits platform.
• Online management of 401(k) plans and employee assistance with retirement planning.

Work Location

The position is located onsite in Gaithersburg/Bethesda, Maryland, within the Washington DC-Baltimore area.