Director of Microbiology Lab

JOB SUMMARY

The Laboratory Director is responsible for the day to day and strategic functions of their department.  The Laboratory Director is responsible for scheduling and prioritizing work to meet customer expectations, performing all work in compliance with the quality, health and safety objectives of the company. Provide technical support to Microbiologists and Group Leaders. Responsible for all aspects of staff management including training, hiring, conducting feedback sessions, employee development, retention and engagement.  The Laboratory Director has direct responsibility for improving production efficiency while meeting the financial and service goals of the laboratory.

The essential duties and responsibilities of this position include the following. Other duties may be assigned as needed.

PRIMARY DUTIES AND RESPONISIBITIES

• Leads the development and implementation of process improvement initiatives that promote increased productivity for each product line.
• Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
• Distributes work to Group Leaders to maximize productivity.
• Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with the Group Leader and Microbiologists.
• Devises and develops processes and methods for the solution of technical problems.
• Trains, mentors and supervises Group Leaders on an as needed basis.
• Confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
• Responsible for scheduling work in support of maintaining all deadlines.
• Ensures that laboratory supplies, consumables, standards are available to perform the analyses within the required project turnaround time.
• Communicates project delays, quality and or technical issues to the Operations Director.
• Reviews lab nonconformance with Group Leaders and Microbiologists. Conducts root cause analysis and implements solutions in collaboration with the team.
• Manages all aspects of department operations as related to operating costs.
• Responsible for the interviewing and the hiring of employees.
• Provides regular ongoing performance feedback while serving as a coach and mentor.
• Responsible for developing and communicating goals to Group Leaders and associated microbiologists.
• Ensures all work is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.
• Follows all safety rules and regulations.
• Follows all cGMP rules and regulations.
• Documents work in a clear and organized manner.
• Maintain a clean and orderly laboratory environment.
• Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.

REQUIREMENTS & QUALIFICATIONS

Qualifications include a Master’s and/or Bachelor’s degree in Microbiology or a related discipline is required. Must have laboratory experience with a 5 years of related work experience combined with a Master’s degree as described above; or a minimum of 8+ years of related work experience combined with a Bachelor’s degree as described above. Knowledge of cGMPs and related compliance regulations and guidances required.

Must have experience with the various products and services the Company offers including stability studies, method development and validation, LIMS and ELN.

This position requires a self-starting, motivated person who possesses excellent interpersonal skills; who is able to assume a leadership role in the laboratory; and, who is able to effectively interact with all departments within the company and with client personnel.

MINIMUM SKILLS REQUIREMENT

• Demonstrated skills in laboratory techniques.
• Solid computer skills.
• Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
• Must be a team player with integrity and concern for the quality of Company products, services and staff members.