Bioanalytical Study Lead (REMOTE)
Job Overview
The Bioanalytical Study Lead will act as an authoritative resource regarding the proper procedures and techniques required over the conduct of the study.
Responsibilities
- Provide oversight and conduct of a project throughout its life at Q2 Solutions.
- Serve as Principal Investigator or scientific lead for GLP-regulated, GCP-regulated, and non-regulated studies.
- Responsible for ensuring quality, delivery, customer satisfaction, and operational excellence of all assigned studies according to client/business requirements.
- Works collaboratively across departments to ensure effective delivery to meet customer needs.
- Lead assay and scientific investigations.
- Responsible for the end-to-end management of a project, encompassing effective management of stakeholder communication and use of appropriate tools to ensure the successful initiation, planning, execution, monitoring, and closure of projects.
- Support to strategic project management initiatives.
Required Knowledge, Skills, and Abilities
- Working knowledge of current regulatory guidelines (GLP, GCP).
- Ability to achieve results through collaborative efforts with others.
- Familiarity with liquid chromatography and combination with mass spectrometry or In vitro (Ithaca Site Location); Understanding of ligand binding and cell-based assays for Immunoassay and Immunogenicity (Marietta Site Location).
- Understanding of routine laboratory procedures.
- Understanding of method development and validation of assays.
- Ability to describe clearly experimental objectives and data conclusions.
- Proven ability to plan, prioritize, and manage a workload for large and complex projects.
- Ability to interact with external and internal clients, and work to objectives/timelines.
- Excellent attention to detail and communication skills.
- Ability to follow verbally communicated procedures.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Minimum Required Education and Experience
- Bachelor's Degree in a scientific field with 5 years' related experience; or equivalent combination of education, training, and experience in GLP laboratory environment.
About our client
With more than 9 million clinical laboratory tests managed annually, we are committed to providing our customers an innovative, progressive, and responsive partner with the quality focus, global experience, and deep medical expertise integral to drug, medical device and diagnostic development.
We work collaboratively with our customers, business partners and colleagues to lead the industry and live our customer promise of providing Actionable Insights for Better Health™.
Our commitment to innovation is how we're building better clinical laboratory services for our customers' - we call it "the lab of the future." The lab of the future will help our customers develop drugs faster and more efficiently. Learn more about how we partner with our customers to build the lab of the future through: Tailored Solutions, Delivery Excellence and Shaping Outcomes.
What we Offer
- Major Medical, Vision, Dental, Disability
- Annual bonus
- 401(k) with 100% vesting after 2 years
- Tuition Reimbursement up to $6k annually
- Generous paid time off and holiday leave
- Other generous benefits
EEO Minorities/Females/Protected Veterans/Disabled
Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe
As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status