Responsible for the operation and regulatory compliance of the Immunoassay Sample Analysis Laboratories while managing the team of laboratory analysts.
You will be responsible for the operation and regulatory compliance of the Immunoassay Sample Analysis Laboratories while managing the team of laboratory analysts.
location: Morrisville, North Carolina
job type: Permanent
salary: $110,000 - 120,000 per year
work hours: 8 to 4
- Manage and direct the daily activities of assigned laboratory work group(s) through appropriate delegation, technical skills training, and work supervision.
- Meet regularly with staff and senior management to discuss and resolve workload and technical issues.
- Screen and assign workload; Plan, prioritize and assign tasks and projects.
- Counsel, train and coach laboratory staff.
- Assist in developing performance standards - Monitor work, develop staff skills and evaluate performance.
- Assist in establishment and revision of laboratory policies and procedures.
- Maintain appropriate control and quality assurance procedures. Ensure compliance with safety requirements.
- Keep abreast of new technical developments.
- Assist with implementation of new tests, equipment, programs and/or procedures in the assigned area(s) as needed.
- Contribute to continuous improvement initiatives to increase quality of services and operational efficiency.
- Foster a unified culture and facilitate collaboration, cooperation, sharing of information and teamwork.
- Participate in initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention.
- Manage staff in accordance with organization's policies and applicable regulations.
- Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
- Ensures laboratory equipment is operational and maintained to optimum operating conditions at all times.
- Maintain the scientific integrity of the data produced by the sample analysis laboratory.
- Perform scientific review of bioanalytical repots and assist with failed run analysis.
- Maintain effective communications between the sample analysis lab and other departments.
- Communicate department issues and provide status updates to management team.
- Track department productivity and quality.
- Manage purchasing and approval of laboratory supplies.
- Responsible for tracking all lab inventory used in experiments.
- In depth knowledge of clinical testing procedures and applicable laboratory testing regulations.
- Knowledgeable and proficient in I/A PK, ADA, and NAb analysis.
- Ability to perform accurate and precise processing of client samples.
- Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific program requirements.
- Knowledge of occupational safety and health rules and regulations.
- Good written and oral communication skills.
- Effective supervision and coaching skills.
- High ethical standards.
- Ability to assess and prioritize multiple tasks, projects and demands.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Ability to adhere to organization, and client Standard Operating Procedures
- Ability to complete documentation per organization, and GLP requirements, as applicable.
- Ability to critically assess data and has a sharp attention to detail.
- Knowledgeable and experienced in Immunoassay / Immunogenicity including laboratory operations and project management.
skills: Chemistry, GLP (Good Laboratory Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.