Molecular Biologist (Onsite)

Please note that this is a 6-months contract position, onsite.

Required

Education:

• Bachelor's degree in Molecular Biology, Genetics, Biochemistry, Biomedical Sciences, or related discipline required.
• Master's degree preferred.

Experience:

• Associate Scientist: 2 - 5 years of experience in molecular assay development or related field.
• Scientist: 5 - 8 years of experience in molecular assay development or diagnostics.
• Experience working in regulated environments (FDA, ISO 13485, design control) preferred.
• Demonstrated ability to independently design and execute experiments.

Technical Skills

• Experience with qPCR and RT-qPCR techniques.
• Understanding of nucleic acid extraction, amplification, and detection.
• Familiarity with multiplex assay development and optimization.
• Experience with analytical validation and performance characterization.
• Basic knowledge of sequencing technologies (Sanger and/or NGS).
• Strong troubleshooting and problem-solving skills.
• Knowledge of design control and risk management principles.
• Working knowledge of BSL-2 laboratory practices.
• Strong data analysis, documentation, and communication skills.

Internal Customers:

• R&D and Assay Development Teams - Execute experiments, generate data, and support assay optimization.
• Bioinformatics - Collaborate on target selection, sequence analysis, and assay performance.
• Regulatory and Quality - Provide technical data and documentation to support submissions.
• Manufacturing and Operations - Support assay transfer and process optimization.
• Program Management - Communicate progress, risks, and timelines.

External Customers:

• CROs and external partners - Support execution of external studies.
• Reference material suppliers - Assist with qualification and performance monitoring.

Job Description

• Support molecular assay design and development activities across multiple programs.
• Conduct feasibility studies and contribute to technical approach selection (e.g., qPCR, RT-qPCR, multiplex strategies) under guidance.
• Execute experimental plans and generate high-quality data to support assay performance and development milestones.
• Contribute to analytical validation studies, including LoD, precision, reproducibility, and robustness.
• Analyze and interpret molecular data, identify trends, and communicate results clearly to the team.
• Support troubleshooting efforts related to assay chemistry, workflow, and instrumentation.
• Participate in cross-functional design reviews and provide technical input as appropriate.
• Contribute to risk assessments (e.g., FMEA) and support design control activities.
• Support development of QC strategies, reference material characterization, and analytical controls.
• Contribute to regulatory documentation by generating data summaries and technical reports.
• Collaborate with Manufacturing and Operations teams to support assay transfer and scale-up.
• Maintain accurate and compliant laboratory documentation in accordance with quality and regulatory requirements.
• Stay current on emerging molecular technologies and contribute to continuous improvement initiatives.

Work Environment

• Ability to lift up to 20 lbs. on a regular basis.
• Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks.
• Vision abilities required include close and distance vision and the ability to adjust focus.
• Personal protective equipment is required as posted.

Physical Demands:

• Ability to lift up to 20 lbs. regularly.
• Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine.
• Vision abilities required include close and distance vision and the ability to adjust focus.
• Personal protective equipment is required as posted.

Candidates must provide their phone number. Job reference code is A5193.