Manager/Senior Manager, Quality Control - Microbiology

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

EDUCATION / CERTIFICATIONS / LICENSES	Essential/Desired
BS in Microbiology/ Biology, or related scientific discipline	Essential
ON-THE-JOB EXPERIENCE
At least 8 years’ GMP Quality Control experience with at least 4 years management experience	Essential
Advanced knowledge of global, especially US and EU GMP guidelines	Essential
SKILLS / ABILITIES
Strong leadership in team management, decision making, change management, collaboration, delivering desired business results, and ability to influence	Essential
Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards	Essential
Strong ability to prioritize and operate with a sense of urgency	Essential
Solid organizational, analytical and problem-solving skills	Essential
Effective communication skills with the ability to interact with all levels of the key stakeholder with demonstrated interpersonal skills	Essential
Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment	Essential
Strong operational and business acumen	Essential
Exhibits highest integrity and committed to ethics and compliance standards	Essential
Open and transparent in sharing data and information	Essential

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