Supervisor, Microbiology Laboratory

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Summary of Objective:

The primary function is to perform microbiological testing of environmental samples, pharmaceutical starting materials, components, and finished products to client-supplied and Pharmacopoeia methodology, such as USP by regulatory standards with a high level of accuracy and minimal personal error. The ability to successfully interpret and execute technically challenging methodology. Calibration, maintenance, and troubleshooting of equipment. Perform method development, validation, and method transfers including authoring protocols and final reports. Training of analysts in techniques for which competency has been demonstrated. Authoring on-time investigations, OOS investigations, and determination of root causes, including working with internal and external customers to resolve issues. Development and implementation of corrective and preventative actions. Review and approval of technical data. Introduction of new equipment, including authoring and executing URS/IQ/OQ/PQ documentation. Write, review, and revise work practices and test methods. Project management. Generation of quotations for projects around technical expertise. Assist/lead customer audits. Maintain metrics concerning the area of responsibility. Drive on-time completion of testing and data correction activities of all personnel performing testing in area of responsibility Allocation of testing to subordinates including collaboration with other department supervisors to ensure on-time testing for other services. This role has supervisory responsibilities.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are the following but other duties may be assigned.

• Manages a team of Microbiologists who are responsible for overall Microbiology Stability, Release and Environmental Monitoring Testing. This includes oversight of 1st shift and 2nd shift.

• Knowledge of USP/EP general chapters and ICH guidelines. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Implements best practices in the Laboratory to maximize operational efficiency. Creates an environment to support a high awareness of housekeeping and safety, security. Maintains focus of zero laboratory safety incidents.

• Prioritizes resources in the department to ensure adequate resources are available for both personnel and equipment to meet customer requirements to deliver on time test results with optimum customer services. Ensures that staff are properly trained to perform their assigned duties.

• Demonstrates good leadership through effective planning, leading by example, delegating and empowering subordinates appropriately. Manages subordinate performance daily, acting quickly and decisively when required to resolve issues.

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring and employee counseling. Reviews and approves time records, requests for leave and overtime.

• Creates an environment which supports and encourages continuous improvement to eliminate waste, improve productivity and reduce costs where possible.

• Ensure that all Company procedures and disciplines are complied with so that all analysis is performed in accordance with cGMP, customer and applicable regulatory standards.

• This position will require the individual to be on an on-call rotation schedule for off shifts, weekends and holidays in case of emergencies in the stability chambers. Other overtime/weekend work may be required.

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager/Director.

• General knowledge and skills of a wide variety of Analytical Tests for Stability and Release purposes which include (but are not limited to): Temperature Monitoring of various Laboratory equipment, sampling and processing of Environmental Monitoring Samples, Processing of Microbiological Samples for Release and Stability, Media Preparation including Sterility, Appearance, pH and Growth Promotion Testing, Biological Indicator Testing, Assist with basic Chemistry Testing as business needs demand i.e. CWS Testing, Incoming Component Testing, Microbial Limits and Specified Microorganism Testing, Method transfer and Method Validation based on Compendial Guidelines from USP, EP, JP and BP.

• General knowledge and skills of equipment and calibration process as it relates to the following equipment: Incubators, pH Meter, Autoclaves, Air Samplers and Analytical Balances. Ability to troubleshoot equipment issues.

• Performs validation and method transfers including authoring and/or technical data review of protocols and final reports. Leads activities to drive future clinical and commercial businesses in microbiology laboratory operations.

• Authors, reviews, and approves Laboratory Out Of Specification, Out Of Trend investigations, Calibration Investigations, and deviations.

• Develops training programs and trains analysts on techniques and methods of analysis for which competency has been demonstrated.

• Develop, manage, and coordinate Microbiology laboratory activities in coordination with the Analytical Laboratory and all PCI facilities and internal customers.

• Drives on-time completion of testing and data correction activities of all personnel performing testing in the Micro Department to meet internal and customer deadlines.

• Assists with submission of capital expense justifications. Participation in the introduction of new equipment, including authoring, execution, and review of URS/IQ/OQ/PQ documentation

• Authors, reviews, implements, and recommends process improvement changes to SOP's and operational policies. Participates in department improvement initiatives and implementation.

• Participation in weekly project management calls with PCI customers. Monitors project timing for Microbiology Laboratory projects and proactively takes action working with laboratory resources to prioritize client expectations to ensure quoted turnaround times and expectations are met to the extent possible.

• Provide support and/or lead PCI personnel and regulatory agencies during audits and project meetings as requested by senior leadership.

• Initiation and Management of Change Controls. Assesses other internal change controls for laboratory impact.

• Generates quotations for projects in the area of technical expertise. Assists with determining appropriate pricing for various projects.

• Works in conjunction with the Quality Assurance Department to perform technical review and approval of Microbiology Laboratory projects.

• Supports lab management to develop future growth plans and expansion of analytical laboratory services.

• Serve as a Subject Matter Expert (SME) on analytical laboratory processes, and procedures

• Authors and/or review annual site Environmental Monitoring reports.

• Gathers historical environmental monitoring results for use in APRs, regulatory audits, and/or customer audits.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Required:

• Bachelor's Degree in a related field and/or 4-6 years of related experience and/or training.

• Statistical and Advanced Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

• High standard of report writing.

Preferred:

• Ability to display a willingness to make decisions.
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems promptly.
• Ability to adapt to changing work environments.
• Ability to set and achieve challenging goals.
• Ability to successful in managing employees
• Ability to exhibit sound and accurate judgment
• Ability to take ownership of issues and work towards resolution

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.