Guidehouse
Scientist, Downstream Process Development
US - MD, Gaithersburg · Full-time
No sponsorship$149k-$248kDetected 1 day ago
StatisticsProject ManagementProcess ImprovementGMPResearchExperimental DesignProtein AnalysisLeadershipCommunicationPublic Speaking
About the role
- This is a full-time role based in Gaithersburg, MD.
- Candidates must receive approved adjudication of their Public Trust prior to onboarding with Guidehouse.
- All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com.
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.
- Partner with manufacturing teams to ensure successful process scale-up, technology transfer, and clinical material production.
- 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.
- 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.
- Demonstrated expertise in downstream process development, purification strategy design, process optimization, technology transfer, and clinical manufacturing support.
Requirements
- Ability to Obtain Public Trust
- 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.
Nice to have
- PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline
- Experience supporting vaccine, biologics, or therapeutic monoclonal antibody (mAb) development programs.
- 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
- 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.
Compensation
- Care.com annual membership
Benefits
- Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
- Benefits include:
- Medical, Rx, Dental & Vision Insurance
- Parental Leave
- 401(k) Retirement Plan
- 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
- Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
- Position may be eligible for a discretionary variable incentive bonus
- Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event.
Equal opportunity
- Equal Opportunity Employer-Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
- All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.
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This listing is sourced directly from Guidehouse's careers page and normalized into a canonical job model.