Manager, Microbiology

Overview

Manager, Microbiology in Albuquerque, NM

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We proudly offer

• 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!

• 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
• Oversees the review and implementation of compliance guidelines, industry trends, customers projects (Method Transfer, Development, etc.), validation efforts, expansion projects and continuous improvement efforts to ensure that Curia meets or exceeds the minimum requirements
• Acts as SME to lead collaboration between departments to trend and continuously improve site
• Contamination Control Strategy and Site Environmental Monitoring Program
• Represent 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
• Builds and evolves the department Training Matrix to industry standards, best practices and continuous improvement
• Writes and revises Microbiology and other relevant SOPs, 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
• Test 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
• Provide oversight for projects to update/maintain official document templates
• Direct and manage the Change Control System
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

• Bachelor’s Degree in Microbiology or related field of study
• Master’s Degree in Microbiology or related field of study with a minimum of three (3) years’ relevant related experience and four (4) years’ pharmaceutical industry experience in a cGMP environment, preferred
• Minimum five (5) years’ relevant related work experience in a cGMP environment
• Minimum two (2) years in a team leadership role of professional level individual contributors
• Previous experience managing Microbiology staff
• Previous experience with pharmaceutical cleanroom environments
• Proficient in the validation/qualification of microbiological techniques
• Knowledgeable in FDA cGMPs (21 CFR 211)

This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and…