Team Lead - Immunology

Job Summary

Basic Summary - Serve as lead/primary technician for both complex and highly complex studies. Responsible for developing and performing laboratory procedures. Develop new techniques, procedures, or scientific innovations that expand the capabilities of the department. Provide leadership and technical guidance in the laboratory.

Essential Duties and Responsibilities: 

• Perform laboratory procedures and collect and record/document research data in compliance with Good Laboratory Practices (GLPs), Standard Operating Procedures (SOPs), study protocols, study­ and laboratory-specific methods or procedures, and company policies/practices. Review the activities and documentation contributing to the study and assure full adherence to the study requirements.
• Perform assays such as ELISA, multiplex, immunophenotyping, comet, and micronucleus, including data analysis. Perform density gradient cell separations.
• Train new staff members for all functions.
• Assist management in scheduling and task assignment as requested with minimal oversight.
• Provide functional oversight to project teams and staff in the absence of direct management.
• Provide technical direction and mentoring to less experienced staff in specific study-related laboratory processes and procedures.
• Operate, perform quality control and maintenance procedures on equipment such as microplate readers, plate washers, cell counters, multiplex instruments, flow cytometers, freezers, liquid scintillation counter, gamma counter, and eyewash stations. Perform analysis of complex and highly complex laboratory assays based on protocols and in compliance with SOP and GLP regulations, as needed.
• Perform study preparation activities including, but not limited to the preparation and maintenance of study notebooks, generating data collection documentation, identifying supply needs, performing laboratory setup, and developing and implementing Study Specific Procedures (as appropriate).
• Generate simple to highly complex tables for data input and report generation. Print and edit computer entries (e.g., laboratory data) as needed. With guidance from scientific staff: review, interpret and integrate data on assigned studies; assist in generating study protocols and assist in sponsor correspondence and interactions; participate in method development, refinement, and validation studies.
• Record project data in accordance with GLP regulations to include creation of Analytical Procedures, data package assembly and assisting in the quality control of project work.
• Assist in the execution of all study related activities required across all studies.
• Review study protocols and provide recommendations on technical and logistical aspects of protocol design.
• Troubleshoot laboratory instrumentation and perform basic maintenance.
• May assist with study preparation activities including ordering supplies, preparing/verifying paperwork, and tube labeling, as needed.
• May assist with receiving and logging reagents, solutions, and samples, as needed.
• Prepare simple to complex lab solutions. Lead and/or conduct method development studies, method validation studies, and equipment validations as needed.

The pay for the position is $30/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

Essential Duties and Responsibilities Continued: 

• Manage and coordinate project timelines, resource coordination, and prioritization of assigned studies in conjunction with laboratory management.
• Take a lead role in reviewing and updating processes and SOPs as assigned.
• Periodically peer review data, documentation, and tabulated summaries as generated/collected by less experienced technical staff.
• Demonstrate effective communication skills through informal discussions with peers, supervisors, and team.
• Participate in preparing responses to both internal and external quality assurance audits.
• Set up laboratory instrumentation utilizing departmental and instrumental software. Independently Identify and lead process improvement initiatives.
• Maintain critical thinking, troubleshooting, and time management skills aligned with needs of the operational area.
• Maintain clean work areas by cleaning dishes/glassware, wiping down countertops, and sweeping/mopping floor as needed.
• Adhere to current health and safety regulations.
• Perform all other related duties as assigned.

Qualifications: 

Education:

• High School diploma or General Education Degree (G.E.D.), preferred. Associate's degree (A.A./A.S.) or equivalent from a two-year college, recommended. Bachelor's Degree (B.S./B.A) or equivalent in biology, chemistry/pharmacy, or similar lab environment or must have demonstrated full knowledge of competencies and positive performance at the previous level, strongly recommended.
• Experience: Five to eight years previous directly related GLP laboratory experience in a pharmaceutical or contract laboratory environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None.
• Other: Exceptional analytical and problem-solving capabilities. Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and GLPs, as appropriate. Fully proficient in technical skills and the operation of data collection equipment. Must be able lo perform effectively as a team member, accurately record data, follow verbal and written instructions, communicate effectively, and interact in a professional manner with management, coworkers, and sponsors. Excellent written and verbal communication skills. Able to prioritize work and meet deadlines. High level of proficiency in the use of standard software and be able to quickly learn and utilize computer programs as needed.