Manager, Microbiology

Job Description

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.

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

Education and/or Experience:

• 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

Preferred Experience:

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

Supervisory Responsibilities

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 achieve both departmental and organizational objectives.

Language Skills:


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.

Mathematical Skills:


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.

Reasoning Ability:


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.

Computer Skills:


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.

Other Skills and Abilities:

• 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

Other Qualifications:

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

There may be other qualifications to add, ad hoc, such as the below:

• May be required to obtain and maintain media qualification
• May be required to wear a respirator

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.


All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.
• The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.
• The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.
• The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.
• Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.
• All environments may be subject to working with or being exposed to cleaning agents.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.