Scientist Downstream Purification

Role Title: Scientist Downstream Purification

Contact and submit your resume to: [email protected]

Location: Gaithersburg/Bethesda, Maryland.

401K, medical, dental, vision and other benefits along with PTO.

Salary Range : $135K - $150K

Position Overview:

Scientist will lead the development, optimization, and technology transfer of downstream purification processes supporting the discovery, preclinical, and clinical development of vaccines, monoclonal antibodies (mAbs), recombinant proteins, virus-like particles (VLPs), and other biologic therapeutics. This role supports programs at NIH by developing robust, scalable, and GMP-compliant purification processes for clinical candidate manufacturing. The Scientist will collaborate with cross-functional teams to advance clinical programs, provide technical leadership in downstream process development and manufacturing support, and contribute to scientific innovation through process improvements and technology development.

Key Responsibilities:

·     Lead the design, development, optimization, and scale-up of downstream purification processes for vaccines, monoclonal antibodies, recombinant proteins, and other biologic products intended for preclinical and clinical development.

·     Develop purification workflows using chromatography, filtration, ultrafiltration/diafiltration (UF/DF), and other downstream processing technologies to achieve target product quality, purity, yield, and process robustness.

·     Plan, execute, and oversee downstream process development activities supporting clinical candidate advancement and GMP manufacturing.

·     Design and execute process characterization and optimization studies using Design of Experiments (DOE) methodologies and statistical analysis tools such as JMP.

·     Develop scalable purification processes that support toxicology studies, clinical manufacturing, and commercial process development.

·     Lead technology transfer of downstream purification processes to GMP manufacturing organizations and provide technical support during manufacturing campaigns.

·     Prepare, review, and approve technology transfer documentation, including process descriptions, process flow diagrams, batch records, and manufacturing support documents.

·     Serve as the downstream purification Subject Matter Expert (SME) during manufacturing operations, technology transfer activities, troubleshooting, facility fit assessments, and process investigations.

·     Develop and oversee viral clearance strategies, including coordination of viral clearance validation studies, evaluation of contract research organizations (CROs), approval of scale-down validation methods, and review of validation documentation.

·     Collaborate closely with Manufacturing, Process Sciences, Quality Assurance, Quality Control, Regulatory Affairs, Analytical Development, and Project Management teams to ensure successful execution of development milestones and clinical manufacturing objectives.

·     Support regulatory submissions, including preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for Investigational New Drug (IND) applications and responses to regulatory inquiries.

·     Review, analyze, interpret, and present scientific data, preparing technical reports, presentations, manufacturing summaries, and scientific publications.

·     Troubleshoot downstream purification challenges and implement process improvements to enhance product recovery, consistency, manufacturability, and operational efficiency.

·     Oversee downstream process execution for toxicology lot production, including review and approval of manufacturing protocols, process documentation, and final production reports.

·     Mentor and train junior scientists and laboratory personnel in downstream purification techniques, laboratory best practices, equipment operation, and scientific problem-solving.

·     Maintain accurate, complete, and well-documented laboratory records in accordance with Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP), as applicable.

·     Contribute to scientific innovation through development of novel purification technologies and dissemination of research findings through scientific conferences, presentations, and peer-reviewed publications.

·     Participate in strategic planning and provide scientific guidance for purification strategies supporting new vaccine, monoclonal antibody, and biologics development programs.

Required Qualifications:

·     Ph.D. in Bioengineering, Chemical Engineering, Biochemistry, Biotechnology, Molecular Biology, or a related life science discipline.

·     Minimum of eight (8) years of industry experience in downstream purification process development for recombinant proteins, monoclonal antibodies, vaccines, or other biologic therapeutics supporting GMP clinical-stage manufacturing.

·     Extensive experience developing and optimizing downstream purification processes, including chromatography, filtration, ultrafiltration/diafiltration (UF/DF), viral clearance, and process scale-up.

·     Demonstrated experience supporting technology transfer from process development to GMP manufacturing.

·     Strong knowledge of bioprocess development principles, process characterization, process validation, and clinical manufacturing operations.

·     Experience supporting regulatory submissions, including IND-enabling CMC documentation and regulatory interactions.

·     Proficiency with statistical experimental design methodologies (DOE) and data analysis software such as JMP.

·     Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and applicable regulatory guidelines.

·     Demonstrated ability to troubleshoot complex purification processes and develop scientifically sound, data-driven solutions.

·     Proven ability to lead multidisciplinary projects while effectively collaborating with cross-functional scientific and manufacturing teams.

·     Excellent scientific writing, technical documentation, oral communication, and presentation skills.

·     Demonstrated experience mentoring junior scientists and fostering a collaborative, team-oriented research environment.

·     Strong organizational skills with the ability to manage multiple priorities while consistently meeting project timelines.

·     Commitment to maintaining accurate, detailed, and well-organized scientific documentation.

Comprehensive Benefits Package

Health Coverage:

• Choice of 3 Blue Cross Blue Shield (BCBS) health insurance medical plans
• Guardian Dental Coverage
• Guardian Vision Coverage

Paid Time Off:

• Generous paid time off program, including federal holidays

Financial Security:

• 401(k) retirement plan managed by The Standard
• Safe Harbor employer contribution matching
• Option for Roth 401(k) contributions
• Automatic enrollment for eligible employees (with opt-out option)
• Ability to roll over retirement accounts from previous employers
• Guardian Basic Life and AD&D (Accidental Death and Dismemberment) Insurance
• Short Term Disability and Long-Term Disability Benefits
• Health Savings Account(HSA) & Flexible Spending Account (FSA) with employer match

Additional Perks:

• Biweekly paycheck
• User-friendly Gusto platform for managing employee information, payroll, and benefits
• Online access to 401(k) plan management through The Standard's Personal Savings Center
• Employee assistance with retirement planning and investment decisions
• Secure online platforms for managing benefits and retirement accounts