Job Title: Senior ScientistJob DescriptionThis contracting Senior Scientist role supports the establishment and operation of a regulated clinical bioanalytical laboratory focused on developing innovative mRNA cell therapies for the treatment of autoimmune diseases. You will perform and oversee complex clinical bioanalytical testing with a strong emphasis on highly sensitive nucleic acid detection, contamination control, regulated laboratory practices, and analytical method qualification and validation. The position offers the potential to transition into a permanent Senior Scientist role or, depending on qualifications and demonstrated capabilities, into a broader laboratory operations leadership position. You will work hands-on at the bench, independently troubleshoot analytical challenges, and coordinate laboratory activities within a small, multidisciplinary and highly collaborative team that is driving latestage development and early clinical programs with direct impact on patients.
Responsibilities
- Independently perform clinical bioanalytical testing using sensitive molecular methods, including quantitative PCR (qPCR) and digital PCR (dPCR/ddPCR).
- Support qualification, validation, troubleshooting, and routine execution of analytical methods used for clinical pharmacokinetic (PK), pharmacodynamic (PD), and biomarker assessments.
- Implement and maintain rigorous contamination prevention and control practices for highly sensitive nucleic acid detection assays.
- Support laboratory operations, including development and maintenance of standard operating procedures (SOPs), equipment qualification, calibration and maintenance, laboratory documentation, and quality systems.
- Execute and review clinical sample testing, ensuring adherence to established analytical procedures, quality controls, and acceptance criteria in a regulated environment.
- Investigate analytical issues, unexpected results, deviations, and potential contamination events, and contribute to root cause analysis and corrective actions.
- Coordinate laboratory activities, clinical sample processing, and analytical workflows to meet clinical development timelines and project milestones.
- Contribute to clinical biobanking activities, including sample tracking, inventory management, and ensuring laboratory readiness for ongoing and upcoming studies.
- Drive continuous process improvement in bioanalytical workflows, documentation practices, and sample management procedures.
- Support preparation of analytical reports, method validation documentation, and materials for regulatory submissions and inspections.
- Participate in assay development and design for regulated work, including planning experiments and optimizing methods for clinical use.
- Assist with vector quantitation, transgene analysis, and lowcopynumber nucleic acid detection to support cell and gene therapy programs.
- Use electronic laboratory notebooks (ELN) and laboratory information management systems (LIMS) to document experiments, manage data, and track samples.
- Collaborate with crossfunctional teams working on cell therapies, CART therapies, and immunotherapies to align bioanalytical strategies with program needs.
- Provide scientific input and constructive feedback on projects, experiments, and data, and, where applicable, support people management and supervisory activities within the laboratory.
Essential Skills
- Bachelors degree with 78 years, Masters degree with 5 years, or PhD with 23 years of experience in Molecular Biology, Biochemistry, Immunology, Biotechnology, or a related scientific discipline.
- Minimum of 5 years of relevant experience in the pharmaceutical, biotechnology, or clinical laboratory industry, demonstrating technical independence.
- At least 2 years of experience working in a regulated laboratory environment such as GCP, GLP, GMP, or CLIA.
- Handson experience with highly sensitive nucleic acid detection methods, including qPCR and digital PCR (dPCR or ddPCR).
- Proven ability to implement and maintain contamination prevention and control practices for molecular assays and nucleic acid detection.
- Experience with analytical method qualification and method validation in a regulated bioanalytical or clinical setting.
- Demonstrated troubleshooting skills for bioanalytical assays, including investigation of assay performance issues, deviations, and potential contamination events.
- Familiarity with laboratory quality systems, including SOP development and adherence, equipment management, and regulated documentation practices.
- Experience with clinical bioanalytical testing supporting PK, PD, and biomarker analysis.
- Strong organizational, problemsolving, and communication skills, with the ability to work independently and within a multidisciplinary team.
- Comfort working primarily in a laboratory environment, performing handson experimental work and coordinating daytoday lab activities.
Additional Skills & Qualifications
- Experience coordinating laboratory operations or supervising laboratory personnel, including managing projects and providing feedback.
- Experience establishing or maintaining regulated laboratory systems and infrastructure.
- Background in clinical bioanalytical testing that supports drug development programs and contributes to BLA and clinical product submissions.
- Experience with cell and gene therapies, CART therapies, or immunotherapy, particularly in the context of autoimmune disease and mRNAbased therapies.
- Handson experience with multiparameter flow cytometry, cellbased assays, and clinical sample processing.
- Experience with lowcopynumber nucleic acid detection, vector quantitation, and transgene analysis.
- Experience with biobanking and sample management, including clinical sample tracking and inventory control.
- Familiarity with electronic laboratory notebooks (ELN) and laboratory information management systems (LIMS) for data and sample management.
- Experience supporting laboratory audits, investigations, corrective and preventive actions (CAPAs), and inspection readiness activities.
- Ability to plan experiments effectively, design assays for regulated work, and contribute to continuous improvement of laboratory processes.
- Interest in working on cuttingedge science in a discoveryoriented, innovative, and collaborative environment that aims to bring meaningful change to patients.
Work EnvironmentThis role is primarily laboratorybased, with approximately 80% of time spent performing handson work at the bench and 20% devoted to data analysis and documentation at a desk. The position is fully onsite, five days per week, during normal firstshift hours. Occasional overtime, including potential weekend and holiday work, may be required to support clinical timelines and laboratory operations. You will work within a regulated laboratory environment (such as GCP, GLP, GMP, or CLIA) using technologies including qPCR, digital PCR (dPCR/ddPCR), flow cytometry, cellbased assays, and electronic systems such as ELN and LIMS. The setting is highly innovative and collaborative, focused on latestage development and early clinical programs for novel mRNA cellbased therapies in autoimmune disease, offering the opportunity to contribute directly to therapies that have a meaningful impact on patients. Job Type & LocationThis is a Contract position based out of Frederick, MD. Pay and BenefitsThe pay range for this position is $62.00 - $75.00/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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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.
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