PURPOSE

Responsible management of the Microbiology laboratory and personnel and execution of the site Environmental and Personnel Monitoring program. This individual is expected to have strong, hands-on, and technical experience of microbiological assays (Endotoxin, Bioburden, TOC) and Environmental Monitoring.

The Microbiology Manager ensures strict adherence to all cGMP/GMP policies and standard operating procedures, provides microbiology technical expertise, and communications effectively with other departments.

The Manager will also have a proven track record with Continuous Improvement and be a champion for the change within the Microbiology team and the QC organization as a whole.

ESSENTIAL JOB FUNCTIONS / DUTIES

• Maintain a safe, efficient, functional, and compliant laboratory operation in accordance with GMP SOP’s, guidelines and regulations.
• Coordinate day-to-day management of QC Microbiology operations, including high-level planning of activities and resources, guidance/performance review within QC, and maintaining or initiating communication cross-functionally.
• Manage and develop the performance of direct reports by setting clear goals, providing performance feedback, supporting career development and recognizing and rewarding exceptional performance.
• Oversee testing in-process samples, drug substance and drug product release/stability and complaint samples.
• Oversee performance of environmental and utility monitoring according to SOP’s, sample test requests, and per approved protocols and investigations.
• Maintain data integrity to the highest industry standards,
• Oversee timely investigation of OOS, OOT, and other laboratory exceptions, and timely management of Deviations, Change Controls, and CAPA, and maintenance of critical reagents, controls, and laboratory supplies.
• Manage outsourced testing activities as necessary and ensure results are reported in a timely and compliant fashion.
• Develop, maintain, and continuously improve robust QC systems to ensure compliance in sample management, testing, data approval, data management, data archiving, and validation and calibration of QC equipment.
• Engage with Continuous Improvement projects cross-functionally that support site improvements and cost efficiency.
• Support and participate in internal and external inspections and audits including regulatory inspections.
• Collaborate with QC Tech Services for method validation, specification generation, stability studies and support life cycle management of methods, Ref. Std. & Critical reagents.
• Support new equipment validation and implementation.
• Provide QC data internally and internally and actively support and participate in cross functional teams (CMC, Quality Management, Management Review Meetings, SRB etc.).
• Ensure timely issue escalation to Quality senior management and cross-functional support teams.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check and drug screen required
• Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

COMPENSATION RANGE

The compensation range for this position is dependent upon experience level of the successful candidate. The ranges are as follows: Manager- $130,00-$150,000 Sr. Manager- $150,000-$170,000

PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail