Cara Patrick Email & Phone Number

The Team Lead will supervise scientists and ensure compliance to all protocols, SOPs, animal welfare, safety, OSHA regulations and company policies. The Team Lead shall function as a leader in technical excellence (displays a high level of competence in a laboratory instrumentation and technical procedures), productivity, and communication within the group. Apply scientific knowledge to develop new methodologies/techniques and optimize existing models/methods. Recruitment, training and certifications of personnel, setting of goals and objectives, monitoring daily performances and completing performance reviews are included in the personnel management responsibilities, although the authority to perform selected activities may be delegated if appropriate. Compliance, safety, and quality are critical and must be the driving force for all activities. Meeting timelines, budget-compliance, and coordination of activities within other internal functions and external customers are also of high priority.

Serve as study supervisor on assigned studies and ensure that all protocol requirements have been met, all data and reports have been verified, and all documentation is accurate and complete. Communicate the results of any findings, deviations or unusual circumstances to the study director and the head of the toxicity testing group in a timely manner. Supervise a group of study investigators, knows, conforms to and ensures compliance to all protocols, GLPs and Animal Welfare Regulations, Novartis SOPs, policies, standards, requirements, and guidelines. Knows, conforms to and ensures compliance of direct reports in following all established safety precautions and OSHA regulations related to test article and animals/specimens handling. Responsible for the technical development and growth of direct reports. Coordinate the scheduling of all study activities within the group, assess staffing requirements, and effectively interact with all support groups. Prepare performance evaluations, set goals and objectives, and recommend/justify promotions in conjunction with head of toxicity testing group for all direct reports. Interview potential candidates for positions within the department and actively participate in the selection process. May be required to respond to questions posed by health authorities (e.g., FDA/EPA/USDA) during inspections. Ensure, in conjunction with the study director, that all studies are archived in a timely fashion and that all applicable QAU findings are addressed. Assist in the evaluation of experimental results and preparation of study protocols, amendments, memos and final reports in conjunction with the Study Director. May write or revise SOPs. May function as Study Director or interim Study Director on non-GLP and GLP studies. May be responsible for departmental computer systems, equipment and calibrations.

In addition to previous duties; Exhibits competence in all routine technical procedures involving all commonly used laboratory animal species. Serves as principal investigator on study protocols and fulfills all associated responsibilities. Responsible for training less experienced personnel in all phases of study conduct. Displays high level of competence in the use of all laboratory instrumentation that is routinely employed and has the ability to troubleshoot equipment problems without supervisory input. Assists in the maintenance of laboratory inventories and equipment. Knows and accurately runs all computer-generated reports and prepares tables required for final reports and demonstrates the ability to solve associated problems. Assists in response to QA observations and participates in applicable corrective action. Independently identifies and corrects data problems. Employs scientific knowledge to develop new or improved methodologies/techniques. Drafts new SOPs or reviews/revises current SOPs as needed. Assists in the preparation of draft study protocols and reports with guidance. Assist supervisor with coordination of technical activities and manpower requirements within the group. Deputy during supervisor absence.

Conducts acute, subacute, chronic, and carcinogenicity studies in rodents and other laboratory animals. Performs technical procedures necessary to implement and conduct study protocols for preclinical safety evaluation animal studies with some supervision (e.g., observing, feeding, handling, dosing, weighing, obtaining physiological specimens and measurements, and collecting, verifying, and maintaining study data). Reports directly to group supervisor and communicates the results and interpretations of all findings in an accurate and timely manner. Conducts/verifies mathematical calculations necessary to establish the required dosage of test materials to be administered. Exhibits competence in all routine technical procedures involving all commonly used laboratory animal species. Knows and conforms to GLPs and Animal Welfare Regulations. Knows and conforms to Novartis SOPs, policies, standards, requirements, and guidelines. Follows all established safety precautions related to test article and animals/specimens handling. Displays competence in the use of all laboratory instrumentation that is routinely employed. Demonstrates the ability to draft new SOPs or revise current SOPs as needed. Assists in the maintenance of laboratory inventories and equipment. Prepares raw data books for archiving. May be required to respond to questions posed by health authority investigators and QA auditors and support all corrective actions.

Conducts acute, subacute, chronic, repro toxicology and carcinogenicity studies in rodents and other laboratory animals.