Manager, Microbiology

Curia • Albuquerque, NM

2d

About The Position

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! Summary The Microbiology Manager is responsible for overseeing the daily operations of the Microbiology laboratory and leading strategic planning for the lab and its staff. They serve as the subject matter expert on contamination control and microbiological testing of parenteral drug products. 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, including protocols, investigations, and lab documentation. The manager is accountable for the entire laboratory team and handles staff management duties such as performance reviews, disciplinary actions, and ensuring proper training. Operating with limited supervision, this position requires the ability to work independently as well as collaboratively on cross-functional teams.

Requirements

• Bachelor’s Degree in Microbiology or related field of study
• 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
• The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
• Leads with integrity and respect
• Provides guidance, coaching, and mentorship to team members
• Demonstrates business acumen
• Fosters a collaborative and positive work environment
• Champions change
• Coaches and Develops
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
• Demonstrates strong attention to detail
• Skilled in the use of computers and proficient in the use of spreadsheets
• Strong organizational skills and ability to prioritize and multi-task in a fast-paced environment
• Proficient in the validation/qualification of microbiological techniques
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• May be required to obtain and maintain media qualification
• May be required to wear a respirator

Nice To Haves

• Five (5) years’ experience in a microbiology leadership role
• Five (5) years of microbiology laboratory experience within a GMP-regulated setting

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 <51>, <61>, <62>, <71>, <85> and <1116>
• 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 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
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees