Clinical Trial Manager Jobs in Delaware

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! QPS, LLC has an opening for a Research Scientist in our Bioanalytical (GBA) department. GBA is comprised of three laboratory operation units: Small Molecules, Proteins, and Oligonucleotides, and each unit has their own Method Development/Method Validation/Sample Analysis (MD/MV/SA) group. In this role, you will play a pivotal part in QPS’ continued expansion of our bioanalytical capabilities to support drug development of small molecules, antibody drug conjugate, protein, and genetic medicines.

The GBA department expertise lies in the quantitation of small molecules, peptides, proteins, oligonucleotides, and biomarkers by various chromatographic (standard flow LC, microflow LC, SFC) coupled to tandem mass spectrometric (MS/MS, MS/HRMS, hybrid/immunocapture mass spec) techniques. We have been pivotal in supporting most of the HIV drugs, most of the HBV/HCV drugs, 2 of the 15 ADCs, and 7 of the 24 oligonucleotide therapeutics approved by FDA/EMA.

We are currently looking for Research Scientists for our Sample Analysis groups. This position will serve as Principal Investigator (PI) on Bioanalytical studies and be responsible for study management, interpretation and reporting of study data, and in concert with team members and peers, will participate in method validation when needed.

QPS’ Story:

Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

Team members enjoy challenging and rewarding work, and are encouraged to achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, teamwork and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.

If this sounds like your ideal work environment, then we would love to speak with you, so apply today!

The Job

• Independently manage multiple sample analysis projects/studies at the same time with minimum supervision.
• Prepare, and/or review and understand study protocols.
• Coordinate with client and internal resources to plan, design and conduct studies.
• Evaluate significance of data and report findings.
• Prepare study summaries and/or reports.
• Set-up, utilize, and maintain complex instrumentation.
• Communicate project timelines, status, data, reports, and inquiries to client and/or study sites, effectively addressing any issues that may arise.
• Maintain the proper level of regulatory compliance for each study, preparing QA related documents and addressing QA audit findings.
• Maintain schedule of projects and timelines.
• Supervise, train and/or mentor junior scientific staff.
• Develop, validate and run sensitive, reliable and efficient LC/MS/MS assays for TK/PK assessment.
• Ensure that GLP regulations and SOPs are followed in all bioanalytical service activities.

Work Location

• This job will be 100% QPS-office/facility based

Requirements

The successful candidate will hold an advanced degree in Analytical Chemistry, Biochemistry, Pharmacology, or related scientific discipline:

• Ph.D. degree
• Recent graduates must have direct experience on LC-MS/MS analysis.
• If more than 2 years since graduation, candidates must have direct experience on method development of bioanalytical assays using LC-MS/MS, particularly having CRO experience.
• Understanding of experimental design and planning, and data collection and analysis software.

Why You Should Apply

• Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
• Structured Career Ladders that provide excellent growth based on your personal aspirations.
• Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
• Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance.
• Park-like setting in Newark, Delaware.
• Internal committees designed with the needs and enjoyment of QPS employees in mind.

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.