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San Diego - Intertek
Job Title: Principal Investigator
Job Location: San Diego, California
Intertek Pharmaceutical Services is a Contract Research Organization (CRO) offering Good Laboratory Practice (GLP) services for bioanalysis of both large and small molecule drugs with expertise in Immunoassay and LC-MS/MS, supporting toxicokinetic (TK) / pharmacokinetic (PK), immunogenicity and biomarker studies. Our laboratory is located in San Diego, California in a facility spanning 46,000 square feet of laboratory, office and sample storage space streamlined to support preclinical and clinical bioanalysis. In 2015 the laboratory was significantly expanded to expedite delivery of fast and cost-effective bioanalysis for global clients.
The Principal Investigator is responsible for oversight of all assigned pre-clinical and clinical sample analysis studies, as well as validation studies in accordance with Intertek SOPs and relevant regulatory requirements to include Good Laboratory Practices (GLP). The Principal Investigator is also responsible for ensuring that quality data is delivered to the client in a timely manner.
• Oversee bioanalytical sample analysis and validation studies, and be the main point of contact between the laboratory and the Sponsor and/or Study Director.
• Create analytical batches, data reduction, data review, and prepare final analytical reports that are written according to SOPs and ready for QC/QAU review.
• Work directly with laboratory management to support GLP regulated and non-regulated studies.
• Hire, train, and supervise laboratory personnel to support bioanalytical activities and ensure laboratory personnel are qualified on applicable bioanalytical procedures.
• Ensure that assigned personnel are fully trained and up-to-date on applicable SOPs and exhibit a strong knowledge of job functions and expectations.
• Develop and maintain metrics to track workflow. Assist in the development and maintenance of review schedules and functional area metrics as applicable.
• Collaborate with client services to monitor the status of each assigned project as applicable.
• Prepare and/or review Sample Analysis Plans (SAP) and validation plans, and ensure studies are followed according to the plans and applicable SOPs.
• Prepare and review SOP, BP, or protocol deviation documentation, associated corrective actions, and prompt notification to the Study Director and/or Sponsor.
• Initiate new projects, and set up sponsor and study specific files including the LIMS.
• Assure that the protocol and all amendments are available and reviewed by applicable laboratory personnel in a timely manner.
• Communicate new projects/protocols and any updates to the Master Schedule.
• Coordinate sample receipt, tracking and storage, and ensure necessary communications are sent to the collection site, central lab, or sponsor. Assure that discrepancies are accurately reconciled and documented.
• Schedule appropriate phases for the study and ensure team resources are adequate for proper execution of the assay schedule. This is to include that all reagents inventories are available and within expiration dates.
• Notify QAU of study schedule and coordinate audit events, including in-process audits.
• Respond to the QC review and QAU inspection and audit reports promptly, with corrective actions.
• Participate in the conduct and reporting of laboratory investigations.
• Responsible for the timely transfer of data and records to the clients, and the archive.
• Work closely with laboratory staff on data and report generation to effectively meet sponsor timelines.
• Update the WIP (Work In-Progress) report and track projects to make sure timelines are being met.
• Contribute to writing and review of SOPs.
• Understand and comply with all safety procedures applicable to the type of work performed.
• Work with the QAU and safety officer to address and correct issues arising from quality assurance or safety audits.
• Bachelor's Degree (BA or BS) in a science or related discipline, with 7+ years of relevant experience in data and/or project management. Master's Degree and direct experience in a GLP bioanalytical laboratory may be considered in lieu of the length of years of prior experience.
• 2+ years of supervisory experience desired.
• Scientific expertise in bioanalysis.
• Demonstrated ability to effectively communicate with clients.
• Demonstrated ability to multi task in a fast paced, high attention to detail environment.
• Effective time management and organization skills.
• Possess a sound background in GLP compliance, knowledge of GCP and other regulatory standards, applicable guidance documents, and white papers.
• Excellent written and oral communication skills.
Intertek offers a salary and benefit package competitively placed within the local market. We promote a culture where motivated, customer-oriented employees can flourish, experience professional fulfillment, and reach their highest potential. We offer medical, prescription, dental, vision, life and disability insurance plans, 401(k) with company match, paid time off (vacation, sick, holiday), Flexible Spending Account (FSA), Employee Assistance Program (EAP), tuition reimbursement, and more.
We are an Equal Opportunity Employer and do not discriminate against applicants due to veterans status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.
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