Scientist, Downstream Process Development

About the role

We are seeking a Scientist to support NIH with the development and clinical advancement of vaccine and therapeutic candidates through leadership of downstream process development activities. This role will oversee purification process development, technology transfer, viral clearance strategies, process optimization, and clinical manufacturing support for recombinant protein products.

The successful candidate will serve as a subject matter expert (SME) for downstream processing activities, working closely with scientific, manufacturing, regulatory, and project management teams to ensure successful development, scale-up, validation, and production of clinical materials. This is a full-time role based in Gaithersburg, MD.

Responsibilities

• Lead development of downstream purification processes for vaccine and therapeutic clinical candidates and support technology transfer for clinical material production.
• Provide technical leadership to scientists and associates in developing downstream methods that achieve product quality, recovery, and manufacturing objectives.
• Collaborate with regulatory teams to support IND submissions and other regulatory requirements.
• Develop and oversee viral clearance strategies and validation activities, including vendor evaluation, scale-down studies, and protocol review and approval.
• Train and mentor laboratory staff on downstream processing techniques, equipment operation, and laboratory best practices.
• Partner with manufacturing teams to ensure successful process scale-up, technology transfer, and clinical material production.
• Write, edit, review, and approve technical documentation, including process descriptions, process flow diagrams, protocols, and production reports.
• Serve as the downstream process subject matter expert (SME) for manufacturing operations, troubleshooting efforts, facility fit assessments, and external collaborations.
• Plan, oversee, and support downstream process activities for toxicology lot production and clinical manufacturing campaigns.
• Collaborate with cross-functional teams to troubleshoot, optimize, and continuously improve downstream processes through experimental design and process development studies.
• Analyze, interpret, and communicate scientific findings through reports, presentations, technical documentation, scientific meetings, and peer-reviewed publications.
• Provide scientific leadership and guidance on purification strategies for vaccine and therapeutic monoclonal antibody candidates across development programs.
• Partner with project managers and stakeholders to establish milestones, monitor progress, and ensure project deliverables are completed on schedule.
• Drive innovation in downstream process development and promote the adoption of novel technologies, methodologies, and scientific advancements.

Requirements

• Master’s degree in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline.
• Minimum of ten (10) years of experience in recombinant protein purification development for GMP clinical-phase products.
• Demonstrated expertise in downstream process development, purification strategy design, process optimization, technology transfer, and clinical manufacturing support.
• Experience developing and overseeing viral clearance strategies, validation activities, and regulatory support for clinical development programs, including IND submissions.
• Experience authoring, reviewing, and approving technical documents, process descriptions, protocols, process flow diagrams, and production reports.
• Demonstrated ability to analyze, interpret, and communicate scientific data and provide technical guidance to multidisciplinary teams.
• Strong oral and written communication skills, with experience presenting scientific findings and novel technologies to technical and professional audiences.
• Proven ability to maintain accurate and detailed records, collaborate effectively across cross-functional teams, and mentor scientific staff.
• Must be able to obtain and maintain a Federal or DoD Public Trust.

Qualifications

Candidates with a PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline are preferred. Experience supporting vaccine, biologics, or therapeutic monoclonal antibody (mAb) development programs is also desirable.

Skills

• Proficiency with Design of Experiments (DOE) methodologies and statistical analysis software (e.g., JMP) for process optimization.
• Experience presenting scientific findings at conferences and contributing to peer-reviewed publications.
• Knowledge of GMP manufacturing operations, process validation, and manufacturing readiness activities.
• Experience supporting external collaborations, contract research organizations (CROs), and technology transfer initiatives across multiple development programs.
• Familiarity with NIH.

Pay

The annual salary range for this position is $149,000.00-$248,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

Benefits

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• Care.com annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)