Job Title: Scientist / Associate Scientist Clinical Bioanalytical Testing (mRNA Cell Therapies)Job DescriptionThis hands-on Scientist or Associate Scientist role supports clinical bioanalytical testing and laboratory operations for the development of innovative mRNA cell therapies targeting autoimmune diseases. You will perform molecular, cellular, and immunological assays that enable clinical pharmacokinetic, pharmacodynamic, and biomarker analyses. The position requires practical experience with highly sensitive nucleic acid detection methods, such as quantitative PCR (qPCR) and digital PCR (dPCR/ddPCR), and prior work in a regulated laboratory environment. You will play a key role in clinical sample testing, assay qualification and validation, contamination control, clinical sample processing, and day-to-day laboratory operations, directly contributing to therapies with meaningful impact on patients.Responsibilities
- Perform clinical bioanalytical testing using molecular techniques, including qPCR and/or digital PCR, to support pharmacokinetic, pharmacodynamic, and biomarker analyses.
- Execute established molecular, flow cytometry, and cell-based assays that support clinical pharmacology and biomarker assessments for mRNA cell therapy programs.
- Support analytical method qualification and validation through experimental execution, data collection, analysis, and thorough documentation.
- Follow rigorous contamination prevention and control procedures for highly sensitive nucleic acid amplification assays, ensuring reliable and reproducible results.
- Process clinical samples, including preparation, testing, storage, tracking, and contribution to biobanking and sample management activities.
- Maintain accurate, complete, and compliant laboratory records in accordance with Good Clinical Practice principles, GLP or other regulated laboratory standards, and established SOPs.
- Support laboratory operations by performing equipment maintenance, reagent and buffer preparation, inventory management, and ensuring overall laboratory readiness.
- Identify, investigate, and clearly communicate assay performance issues, unexpected results, and potential deviations to scientific and operations stakeholders.
- Collaborate closely with scientific and laboratory operations personnel to meet clinical testing timelines and adapt to evolving project priorities.
- Use electronic laboratory notebooks (ELN) and laboratory information management systems (LIMS) to document experiments, manage samples, and support data integrity.
- Contribute to method development and optimization activities related to nucleic acid assays, vector quantitation, transgene analysis, and cell-based assays as needed.
- Participate in continuous improvement of laboratory workflows, contamination control strategies, and quality control processes in a regulated environment.
Essential Skills
- Bachelors degree (BS) with at least 4 years, or Masters degree (MS) with at least 2 years of experience in Molecular Biology, Biochemistry, Immunology, Biotechnology, or a related scientific discipline.
- Minimum of 2 years of relevant experience in the pharmaceutical, biotechnology, or clinical laboratory industry.
- Hands-on experience with highly sensitive nucleic acid detection techniques, including qPCR and/or digital PCR (dPCR/ddPCR).
- Experience working in a regulated laboratory environment such as GCP, GLP, GMP, or CLIA.
- Practical understanding of contamination prevention and control for nucleic acid amplification assays.
- Experience performing laboratory testing according to established SOPs and quality control requirements.
- Strong attention to detail and commitment to laboratory data quality and integrity.
- Excellent organizational skills with the ability to manage multiple assays, samples, and documentation requirements.
- Ability to work collaboratively in a cross-functional, laboratory-focused team and adapt to changing priorities.
- Proficiency in nucleic acid assays, including DNA and RNA extraction, amplification, and detection.
- Familiarity with bioanalytical workflows and clinical sample testing in support of pharmacokinetic, pharmacodynamic, and biomarker studies.
Additional Skills & Qualifications
- Experience with clinical bioanalytical testing and analytical method validation, including assay qualification and method validation activities.
- Experience with multiparameter flow cytometry and cell-based assays in support of immunological and cellular analyses.
- Experience with clinical sample processing, biobanking, and sample management, including storage and tracking.
- Experience in cell and gene therapies, CAR-T therapies, or immunotherapy, particularly in the context of autoimmune disease.
- Experience with low-copy-number nucleic acid detection, vector quantitation, and transgene analysis.
- Familiarity with electronic laboratory notebooks (ELN), LIMS, and regulated laboratory documentation systems.
- Knowledge of immunology and immunotherapy concepts relevant to mRNA cell therapies and clinical pharmacology.
- Experience in method development for nucleic acid detection and cell-based assays in regulated environments.
- Understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and quality systems applicable to clinical bioanalytical laboratories.
Work EnvironmentThis role is primarily onsite in a laboratory setting with some data analysis work, typically five days per week during standard first-shift hours. The position involves hands-on work setting up and operating equipment in R&D and manufacturing environments, with the majority of time spent at the bench. Work is largely conducted in a BSL-2 laboratory, with approximately 6080% of time in the lab and the remaining time at a desk for data analysis and documentation. Bench work includes activities in the hood and routine handling of clinical and research samples. Occasional overtime, weekend, or holiday work may be required to meet critical clinical testing timelines. The environment emphasizes cutting-edge science, innovation, and collaboration within a clinical pharmacology group focused on novel cell-based therapies for autoimmune diseases. Team members work closely together on late-development and early clinical programs, contributing to future BLA submissions and clinical products, with a strong culture of scientific rigor, data quality, and direct impact on patient outcomes. Dress is appropriate for a laboratory environment, including adherence to standard lab safety practices and use of personal protective equipment as required. Job Type & LocationThis is a Contract position based out of Frederick, MD. Pay and BenefitsThe pay range for this position is $48.00 - $58.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.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) Job Type & LocationThis is a Contract position based out of Frederick, MD. Application DeadlineThis position is anticipated to close on Nov 21, 2026. Workplace TypeThis is a fully onsite position in Frederick,MD.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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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