The High-throughput Clinical Immunoassays & Diagnostics Team resides under Pfizer Vaccine Research & Development and operates in a well-controlled setting under cGLP regulations to support Pfizer’s vaccine programs. This position within the Ligand Binding Immunoassays Group will be responsible for managing clinical testing throughput activities and critical reagent qualifications for various immunoassays in support of late stage clinical vaccine studies. The incumbent will work with their manager to plan and critically analyze immunoassay-based experiments for assigned projects, as well as coordinate laboratory activities with various functional groups and junior colleagues to successfully meet project deliverables. In addition to required immunoassay experience, the incumbent should have a working knowledge of basic statistical analyses and be able to interpret/communicate statistical results to colleagues in the context of immunoassays.
- Primary duties include managing clinical throughput timelines and coordinating critical reagent qualification activities.
- Point of contact for various functional groups to coordinate laboratory activities; provide scientific and organizational leadership through strong interpersonal skills.
- Manage four or more direct reports by setting goals, creating development plans, and providing coaching/mentoring.
- Coordinates the efforts of junior colleagues to complete their work assignments and collect data.
- Writes standard operating procedures, reagent qualification reports and other technical documents as assigned.
- Follows standard operating procedures and documents all work in a clear, compliant manner.
- Ensures stable, long-term performance of validated assays.
- Trains junior colleagues on defined laboratory processes for assigned assays.
- Satisfactorily completes all laboratory and safety training per departmental requirements.
- Where applicable, performs job responsibilities in compliance with cGLP regulations and other regulatory agency requirements.
- BS/BA degree in life science (e.g. biology, cell biology, immunology, virology, microbiology) with at least 10 years of experience or MA/MS degree and at least 7 years of laboratory experience.
- Strong verbal and written communication skills required.
- Ability to multi-task and work efficiently and productively in a fast-paced and highly collaborative environment.
- Proficiency in the use of Microsoft Office applications (e.g. Word, Excel, PowerPoint).
- Basic understanding of common statistical calculations.
- Proven ability to analyze and interpret laboratory results.
- Hands-on experience in a regulated testing laboratory setting is desired, including adhering to SOPs, instrument IOQ/PQ, and good documentation practices.
- Experience executing and troubleshooting immunoassays, particularly Luminex-based.
- Hands-on experience with sterile technique, pipetting, Luminex-based assays and operating automated liquid handlers, are preferred.
- Management experience is preferred.
Work is primarily performed at the laboratory bench and at an office desk using a computer. The job involves lifting relatively light loads, generally not more than 10 pounds.
This position requires occasional weekend work to meet critical timelines.
Other job details:
- Eligible for Employee Referral Bonus
- Relocation support available