Regulatory Bioassay Research Scientist

About the role

The researcher will independently lead and conduct research projects that will generate valuable scientific findings to support data-driven regulatory decisions and policies.

Responsibilities

• Perform cell-based assays for therapeutic proteins or peptides and compile sample information into multiple databases/data management systems;
• Operate and maintain laboratory instrumentation such as plate reader or bioanalytical analyzer for the analysis of the effect of therapeutic protein and peptides on cellular metabolism;
• Culture mammalian cells using aseptic techniques for BSL 2 cell lines cell lines;
• Perform characterization analyses such as RNA extraction for RNAseq analyses, protein preparation for western-blot analyses, or cytokine/hormone measurement in supernatant or serum;
• Perform surveillance testing and investigate the mechanism of action of therapeutic protein and peptides to identify relevant assay readouts that could be monitored using a cell-based assay;
• Establish new analytical methods to evaluate the biological activity of biotechnology products and/or complex generics;
• Collect sample information and laboratory testing results from multiple data sources\databases and perform data processing and analysis of acquired according to project plan;
• Auxiliary with the upkeep of inventory of lab supplies, lab purchases, and laboratory equipment and instrumentation maintenance and repair;
• Prepare analysis reports, status reports and presentations to support regulatory operation decisions and improvements;
• Write manuscripts and/or technique reports for publications or white papers;
• Conduct weekly meetings with program lead on programs status, action items and/or issues;
• Provide monthly status reports to program leadership and project stakeholders including research findings, project schedule and milestone updates;
• Complete all corporate and client mandatory training and maintain required credentials.

Requirements

• Master’s degree in Chemistry, Biotechnology, Biology, Biochemistry, Cell Biology, Bioengineering, or related field(s) of study.
• 3-6 years of experience in developing bioassays for biotechnology products and peptides for the comprehensive characterization of the biological activity of these therapeutic proteins and peptides.
• Experienced in data collection, analysis, and writing scientific writing and technical reports.
• Knowledge of Good Laboratory Practices (GLP) or International Organization for Standardization (ISO) practices.
• Strong oral and written communication skills to engage with stakeholders.
• Understanding of regulatory interpretations (e.g. CMC), targets (e.g. product efficacy\safety thresholds), project plans and timelines.

Qualifications

• PhD degree in Chemistry, Biotechnology, Biology, Biochemistry, Cell Biology, Bioengineering, or related field(s) of study.
• A working knowledge of biopharmaceutical manufacturing, process development, and biotechnology research, as well as understanding of insulin and GLP1-R signaling pathways are also preferred.
• Experience in developing potency bioassays in a relevant field.

Skills

• Ability to obtain Public Trust.
• Ability to work onsite at the client location in Silver Spring, MD.

Benefits

• The annual salary range for this position is $65,000.00-$108,000.00.
• 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, 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.).

Pay

• The annual salary range for this position is $65,000.00-$108,000.00.

Schedule

• Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD.