Clinical Biomarker Lab Operations Associate

Synectics Inc.; New Haven (CT); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Job summary

Synectics Inc. in New Haven, CT is seeking a Clinical Biomarker Lab Operations Associate to support early‑phase trials with GxP‑compliant oversight. The role blends office-based quality oversight (75%) with hands‑on lab support (25%) to monitor inventory, data, and documents.

You will drive continuous improvement, manage laboratory assets, and collaborate across Global teams to ensure timely, audit‑ready deliverables while maintaining data integrity.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Chemistry, Immunology, or a related scientific discipline.
• 1-4 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.

Responsibilities

• Support early-phase clinical trials by monitoring laboratory inventory, data, and documents to ensure GxP compliance.
• Provide bench support when lab workload is high.
• Enhance Operational Excellence and maintain inspection-ready status by monitoring quality incidents and procedural gaps.
• Manage laboratory assets, qualification and maintenance reports, and study plans including submission-ready formatting.
• Quality review of laboratory data to maintain accuracy against source and improve data table creation efficiency.
• Coordinate with Biomarker Lab Head and project leads to meet milestones and quality metrics.

Skills

Attention to detail

Time management

Written and verbal communication

Multi-tasking

Independent problem-solving

Process improvement

Data management

Education

Bachelor's degree in Biology/Biochemistry/Chemistry/Immunology

Tools

IDBS E-WorkBook

Veeva Vault

Generis CARA

Microsoft Teams

Microsoft Excel

Microsoft Word

Adobe Acrobat

Job description

• 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.
• 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 departments in a project‑dependent manner (e.g. Global Workplace Experience/Laboratory Instrument Services, Global PCRU Quality Assurance & Training, Global Digital/Creation Center, 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.
• 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

Description

• 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.
• 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 departments in a project‑dependent manner (e.g. Global Workplace Experience/Laboratory Instrument Services, Global PCRU Quality Assurance & Training, Global Digital/Creation Center, 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.
• 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

Qualifications

• Bachelor's degree in Biology, Biochemistry, Chemistry, Immunology, or a related scientific discipline
• 1-4 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
• Prefer a 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
• 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
• Ability to learn new software systems and electronic laboratory notebooks quickly
• A strong interest in laboratory operations, learning new techniques, and working within a regulated environment.
• Standard work schedule is generally 8:00/9:00 AM to 5:00 PM.

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.