Analytical Scientist

As an Analytical Scientist, you will bring hands-on expertise in quality control and molecular biology, focusing on assay development and analytical testing within a GMP setting. You will design, optimize, and execute a variety of cell- and protein-based assays to characterize biologics, supporting product release and stability studies. Proficiency in method qualification and validation, data analysis, and cross-functional collaboration with R&D and manufacturing teams is essential. You will also have a strong understanding of regulatory expectations, with experience in authoring protocols, technical reports, and SOPs.

Responsibilities

• Perform flow cytometry-based QC testing for product characterization, release, and stability studies.
• Conduct additional QC analytical techniques such as ELISA, qPCR, endotoxin testing, cell-based assays, biochemical assays, HPLC-based methodology, and others as required.
• Support GMP-compliant quality control operations, including documentation, sample handling, routine instrument calibration, maintenance, and troubleshooting for analytical instruments.
• Review and maintain accurate, GMP-compliant laboratory records, including SOPs and deviation reports.
• Conduct method qualification and validation following ICH and regulatory guidelines.
• Participate in investigations of out-of-specification (OOS) results and deviations.
• Collaborate with cross-functional teams, including manufacturing, quality assurance, and R&D, to ensure smooth workflow and compliance.
• Maintain a clean and organized laboratory environment following safety and regulatory guidelines.
• Analyze, interpret, and report experimental data with attention to detail and scientific rigor.
• Author and review technical documents including protocols, validation reports, SOPs, and technical summaries.

• Quality Control
• Molecular Biology
• Assay Development
• Cell-based Assay
• Protein-based Assay
• Flow Cytometry
• ELISA
• qPCR
• Endotoxin Testing
• Biochemical Assay
• HPLC
• Western Blot
• Method Development
• Qualification
• Validation
• Regulatory Compliance
• Bioanalytical Assays
• GMP
• GLP

• Bachelors, Masters, or Ph.D. in Molecular Biology, Biochemistry, Analytical Chemistry, or related field.
• 2+ years of hands-on experience with flow cytometry in a QC, analytical, or research setting (academic or industry experience acceptable).
• Experience working in a GMP, GLP, or regulated laboratory environment is preferred.
• Hands-on experience with bioanalytical assays such as flow cytometry, ELISA, qPCR, Western blot, cell-based potency assays, or other relevant methods.
• Strong understanding of method development, qualification/validation, and regulatory compliance (FDA/ICH guidelines).
• Strong attention to detail and ability to follow standard operating procedures (SOPs) accurately.
• Excellent documentation and communication skills, with the ability to work effectively in a team-based environment.
• Preferred: Masters with a PhD mindset would be ideal. Some flow cytometry experience is a must-have.

This position is based in a GMP laboratory environment, where collaboration within a small team fosters initiatives in developing immunity and cancer solutions. The role involves working with innovative technology for delivering medicine through capsules, providing patients with more convenient options than IV infusion centers.

Pay and Benefits

The pay range for this position is $30.00 - $38.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Rockville,MD.

Application Deadline

This position is anticipated to close on Jul 7, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email ... for other accommodation options.