Manager, Bioanalytical Laboratory

ESPONSIBILITIES

• 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.

PHYSICAL REQUIREMENTS

• 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