Location: Buena, NJ
The Director, QC Microbiology Laboratory will be responsible to ensure compliance to GxP from the perspective of Quality Control (Microbiological Testing, Raw Material consumable, excipient, API testing and release and Stability). This position proactively drives change and improvement to QC microbiology lab, while establishing a culture of compliance through implementation of harmonized standards, testing, monitoring and reporting.
Reporting Relationships: Up to 10 direct/Indirect reports
- Maintain the QC Microbiology Lab and function in full cGMP-compliance and continue to challenge the status quo of the labs to enhance throughput efficiency and Compliance while ensuring Method lifecycle management in these areas.
- Responsible to install laboratory equipment and qualify/validate lab equipment for intended use in QC laboratory to support testing (e.g. Chemical Testing, Sterility Testing).
- Ensure proper oversight and management for protocol development, report writing, trend report and deviation management.
- Ensures that priorities (lab scheduling, logistics and flow of activities) for testing and review are set and followed.
- Ensures proper scheduling and prioritization of workload and staff to ensure all activities are performed in a timely manner.
- Leads laboratory investigations and facilitates root cause analysis.
- Reviews documents to ensure completeness, accuracy, consistency, and clarity and ensures that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs.
- Ensure programs for trending are in place including assessment for CAPAs based on trend conclusions.
- Collaborate with Manufacturing, Supply Chain and Logistics and Quality to ensure an
uninterrupted supply of materials for use in Manufacturing.
- Participate in audits (internal / external) where necessary (prep, support, interactions) internal/external audit program.
- Participate in the preparation and consolidation of the budget of the Quality Unit.
- Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
- Collaborates significantly with cross functional groups, including QC Analytical, QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
- Manage a team of Microbiologist in the Quality Control department.
- Perform microbiological testing (endotoxin, bioburden) for water.
- Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product.
- Perform environmental monitoring of the clean rooms (under ISO and EU specifications).
- Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results.
- Perform microbial characterization (gram stain, catalase, oxidase, and coagulase tests).
- Prepare and send out samples for microbiological identification.
- Maintain historical files on organisms found in classified areas; microbial identification and trending.
- Inspection of media fills operations.
- Perform other microbiological assays such as Sterility (including biological indicator testing), Growth promotion testing of all incoming media used in the microbiology laboratory, Preservative effectiveness testing, and Microbial limit testing.
- Initiate OOS/OOT or Environmental Monitoring Excursion Investigations.
- Delivery of results in time and quality (e.g. review and approve validation, qualification protocols and reports).
- Complete and ensure projects are progressing according to plan and quality expectations.
- Ensure there is a limited number of gaps identified during external and internal audits and in the same context, none of the issues identified are severe / critical.
- No critical observations during authority inspections.
- No delay with new product introductions caused by the lab.
- Support implementation of programs such as but not limited to LIMS, MES.
- Ensure programs are in place for trending which includes determination of alert and action limits and systems in place to take action accordingly.
- Education: BS in microbiology or closely related field with 7 years’ experience in a microbiology lab, preferably in the pharmaceutical or biotech industry; with 3-5 years of that experience in a leadership role in the microbiology lab.
- Ability to maintain integrity and honesty at all time and communicate with transparency.
- Continuously drive to improve process for improved performance
- Ability to lead and be accountable for team’s performance and results
- Manage internal and external relationships
- Develop strategy and create metrics to measure effectiveness of strategy
- Provide leadership to direct and indirect reports
- Coaching and conflict resolution
- Handle incidents appropriately and with a sense of urgency
- Ability to problem solve and identify root cause
- Ability to communicate at all levels and across all functions
- Ability to build, lead and motivate team
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.