QC Bioassay Associate

at  Tunnell Consulting

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

TITLE: QC BIOASSAY ASSOCIATE

Job Summary: Seeking a highly motivated and detail-oriented QC Bioassay Associate to join our client’s Quality Control team on the second shift. The successful candidate will be responsible for performing testing and evaluations in support of bioassay methodologies to ensure compliance with industry standards and internal quality specifications. This is a contract role, estimated 3 months onsite. Our client is seeking local candidates who can commute daily to the greater Lexington, MA area.

Qualifications:

• Bachelor’s degree in Biology, Biochemistry, or a related field; or equivalent experience.
• 2 years of experience in bioanalytical methods (development, validation, and transfer); methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays and flow cytometry-based assays
• Previous experience in quality control or similar role required.
• Knowledge of regulatory requirements (e.g., FDA) required

• Conduct routine and non-routine testing, as well as review in-process, drug substance (DS), and drug product (DP) release and stability samples, in accordance with Standard Operating Procedures (SOPs) for q-PCR, Potency Assay, TCID50, and other cell-based assays.
• Collaborate effectively with internal and cross-functional teams as an active participant, providing training and executing assays to meet release deadlines.
• Participate in equipment validation, method transfer/validation, and the execution of special protocols.
• Take responsibility for the generation, revision, and review of protocols and reports as needed.
• Demonstrate a strong understanding of regulations, effectively applying them to various situations and identifying deficiencies with minimal guidance.
• Conduct bioassay testing and analysis of biological samples according to established protocols and guidelines.
• Prepare and maintain reagents, standards, and controls needed for testing.
• Document all test results accurately and comprehensively, ensuring traceability and compliance with Good Laboratory Practices (GLP).
• Identify deviations from expected results and participate in investigations.
• Maintain a clean and organized laboratory environment.

• Adhere to safety and regulatory standards in all laboratory activities.

  Qualifications:

• Bachelor’s degree in Biology, Biochemistry, or a related field; or equivalent experience.

• 2 years of experience in bioanalytical methods (development, validation, and transfer); methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays and flow cytometry-based assays
• Previous experience in quality control or similar role required.
• Knowledge of regulatory requirements (e.g., FDA) required.

Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.
Please be advised that Tunnell resources are required to comply with all client COVID-19 requirements. This may include a requirement to be fully vaccinated against COVID-19, in accordance with the CDC guidelines and subject to legal requirements. Please contact Tunnell’s Human Resources department if you would like to discuss any questions or concerns