Manager, Bioanalytical Laboratory
- 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- 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 Q2 Solutions, and client Standard Operating Procedures
- Ability to complete documentation per Q2 Solutions, 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.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in a sciences related field and 7 years relevant experience ;or equivalent combination of education, training and experience.
- Minimum of 5 years managing staff (preferred 7 or more direct reports).
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Work is performed in a laboratory environment, full manual dexterity and visual acuity required
- May be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools and equipment
- Occasional travel