Position: Bioanalyst I

Location: New Haven, CT

Work Arrangement: 100% Onsite, 40 hours/week

Position Overview

This role supports a clinical biomarker laboratory within a Phase I clinical trial unit. The laboratory works with human biological specimens in a regulated environment. This is an entry-level opportunity intended for candidates interested in developing a career in laboratory sciences and bioanalysis.

Key Responsibilities

• Sample processing and specimen handling
• Inventory management and ordering laboratory supplies
• Equipment management and upkeep
• Quality control review of laboratory data and documentation
• Maintaining accurate records and audit trails
• General laboratory and administrative support activities
• A mix of laboratory bench work and desk-based responsibilities

Required Qualifications

• Bachelor's degree in Biology, Biochemistry, Chemistry, Immunology, or a related scientific discipline
• Approximately 1 to 3 years of laboratory experience preferred
• Basic laboratory skills, including pipetting and safe specimen handling
• Understanding of sterile techniques and laboratory safety practices
• Strong attention to detail and quality mindset
• Ability to manage multiple tasks and stay organized
• Proficiency with Microsoft Office applications (Excel, Word, Teams)
• Ability to learn new software systems and electronic laboratory notebooks quickly

Preferred Candidate Profile

• The manager is seeking a candidate who views this role as a stepping stone toward a future laboratory analyst position.
• Candidates should demonstrate a strong interest in laboratory operations, learning new techniques, and working within a regulated environment.

Additional Notes

• Standard work schedule is generally 8:00/9:00 AM to 5:00 PM.
• Occasional weekend support may be required during large study periods, so flexibility is preferred.
• Initial contract term is expected to be 12 months, with possible extension based on business needs and performance.

JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.

• This is a development opportunity for a lab generalist looking to specialize in bioanalytical quality and operations.
• The position is primarily office-based (approximately 75%) with a focus on quality oversight, while also requiring hands-on lab support (approximately 25%) during peak times.
• A Clinical Biomarker Lab Operations Associate will support early-phase clinical trials by monitoring laboratory inventory, data, and documents to ensure GxP compliance.
• The role will contribute to continuous improvement efforts and is expected to provide bench support when lab workload is high.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

• Enhance Operational Excellence: Leverage problem-solving skills to increase the efficiency of lab inventory and asset management, to monitor and report all quality incidents in order to assist in the identification of procedural gaps, to continuously adapt to new GxP regulations, and to remain inspection-ready
• Master the GxP Document Lifecycle: Manage laboratory assets (qualification and maintenance reports), laboratory test methods (procedural documents and training tasks), method validation study plans and reports, clinical biomarker study plans and reports to include quality review, table creation, and submission-ready formatting
• Ensure Data Integrity: Quality review of laboratory data to maintain accuracy against source, leverage/learn new software or artificial intelligence tools to increase efficiency in data table creation, and assist in the qualification of automated procedures for data table creation
• Drive Project Timelines: Communicate and coordinate with Biomarker Lab Head, Biomarker Scientists (Project Leads and Analysts) to successfully execute clinical biomarker project milestones; Attend biweekly Biomarker Study Management Meetings to discuss project status and anticipated workflow challenges and to discuss quality metrics and follow-up investigations
• Collaborate Across a Global Organization: Engage external Client departments in a project-dependent manner (e.g. Global Workplace Experience/Laboratory Instrument Services, Global PCRU Quality Assurance & Training, Global Client Digital/Creation Center, Client Clinical and Translational Biomarkers) to ensure all deliverables are completed within team expectations for quality and time
• Provide Critical Lab Support: As needed, assist with hands-on lab activities, including instrument maintenance and human biospecimen processing/management, to support the team during periods of high workload and ensure project timelines are met.

QUALIFICATIONS / SKILLS

• Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
• Bachelor’s degree in a biological or biochemical science
• 2-4 years of hands-on laboratory experience, with a demonstrated ability to apply that scientific understanding to process workflows for managing data, documents, and/or laboratory inventory
• Advanced proficiency using standard applications: Microsoft Teams, Microsoft Excel, Microsoft Word, Adobe Acrobat
• Strong computer skills to quickly learn, retain, and apply knowledge to new file and data management tools, e.g. IDBS E-WorkBook, Veeva Vault, Generis CARA
• Exceptional attention to detail to identify non-compliance or discrepancies
• Exceptional time management to meet deadlines
• Strong written and verbal communication skills within and across departments
• Organized to multi-task and comply with both general operating procedures and project-specific requirements
• Independent problem-solving skills
• Courage to suggest process improvements that enhance efficiency and/or product quality
• Positive attitude with a desire to learn and contribute to large team projects that occasionally require flexible working hours
• Preferred qualifications: Firm understanding of immunoassay techniques and readouts (e.g. ELISA/ECL assays, or flow cytometry assays), Firm understanding of descriptive statistics and regression analyses, work experience in a regulated lab (GxP, CLIA) or quality assurance department

ORGANIZATIONAL RELATIONSHIPS

• Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.
• Works directly with PCRU Biomarker Scientists (all levels: Senior Associate to Principal), Lab Documentation Coordinator, Lab Information Data Manager, and the Quality Assurance & Training Team
• May work with the following external Client departments (project-dependent): Global Workplace Experience/Lab Instrument Services, Clinical and Translational Biomarkers, Clinical Data and Information Services, Digital and Technology