Regulatory Bioassay Research Scientist

Guidehouse•Silver Spring, MD

1d•Onsite

About The Position

We are currently searching for research personnel /scientist to support our federal client in bioassay development, validation and implementation for biotechnology products (biosimilars) and complex generics. The researcher will independently lead and conduct research projects that will generate valuable scientific findings to support data-driven regulatory decisions and policies.

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

Nice To Haves

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

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
Assist 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

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.)
Position may be eligible for a discretionary variable incentive bonus