Analytical Scientist

Actalent • Rockville, MD • 3d ago

Job Title: Analytical ScientistJob Description

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.

Essential Skills

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

Additional Skills & Qualifications

Bachelor's, Master's, 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.

Work Environment

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.

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