Manager, Microbiology

About the role

The Microbiology Manager oversees the daily operations of the Microbiology laboratory and leads strategic planning for the lab and its staff. This role involves significant participation in customer and regulatory audits, new client interactions, site metrics meetings, site-wide improvement projects, budgeting, and data review and interpretation.

Responsibilities

• Develops and maintains leader standard work in the laboratory
• Aligns and maintains staff shift schedules with required manufacturing support functions
• Well versed in CGMP guidelines, ISO 17025, and all USP microbiological testing, especially USP , , , , and
• Maintains laboratory policy and procedure manuals and assists in developing and writing procedures; validates the procedures and document preparation
• Responsible for the timely completion of projects, CAPAs, and investigations
• Manages, conducts and/or delegates, the final review and approval of environmental and microbiological test results including contract labs to support lot disposition and deliverables as prioritized by Site Leadership
• Acts as SME to lead collaboration between departments to trend and continuously improve site
• Represents the department and company in all Regulatory, Customer Audits and Internal Audits
• Responsible for timely response to audit observations and execution of related CAPAs
• Develops and executes training on laboratory methods, instrumentation and aseptic technique
• Buils and evolves the department Training Matrix to industry standards, best practices and continuous improvement
• Writes and revises Microbiology and other relevant SOP’s, as required
• Provides technical input on product testing issues and instrumentation/equipment
• Ensures that laboratory is in cGMP compliance conducting inspections of all monitoring systems and equipment
• Ensures proper recording and review of data
• Tests the integrity of raw materials or finished products
• Conducts and documents failure and complaint investigations
• Serves as liaison to service, calibration, and technical representative
• Facilitate the revision and release of all controlled documents
• Facilitate mandatory reviews of SOPs and month-end reports
• Direct and manage the Change Control System
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings

Requirements

Minimum of five (5) years experience in microbiology or related field within a GMP-regulated environment

Minimum of two (2) years experience in a microbiology leadership role

Previous experience with pharmaceutical cleanroom environments

Knowledge of 21 CFR 211 and EU Annex 1 cGMP requirements

Qualifications

• Bachelor’s Degree in Microbiology or related field of study
• Five (5) years’ experience in a microbiology leadership role
• Five (5) years of microbiology laboratory experience within a GMP-regulated setting
• Preferred: Five (5) years of microbiology laboratory experience within a GMP-regulated setting

Skills

• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages
• Strong grasp of algebraic and geometric principles
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Effective presentation skills
• Strong organizational skills and ability to prioritize and multi-task in a fast-paced environment
• Strong attention to detail
• Skilled in the use of computers and proficient in the use of spreadsheets
• Leadership skills, including guiding, coaching, and mentoring team members
• Business acumen and ability to foster a collaborative and positive work environment
• Championing change and promoting a safe and healthy work environment

Benefits

Generous benefit options (eligible first day of employment)

Paid training, vacation and holidays (vacation accrual begins on first day of employment)

Career advancement opportunities

Education reimbursement

401K program with matching contributions

Learning platform

And more!

Pay

TBD

Schedule

TBD