Manager, Microbiology jobs in United States
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Curia · 1 week ago

Manager, Microbiology

Curia is a global contract development and manufacturing organization dedicated to providing life-saving treatments. The Microbiology Manager is responsible for overseeing daily operations of the Microbiology laboratory while leading strategic planning and ensuring compliance with regulatory standards.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote
Hiring Manager
Hang Nguyen
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Responsibilities

Develops and maintains leader standard work in the laboratory
Aligns and maintains staff shift schedules with required manufacturing support functions
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

Qualification

Microbiology leadershipGMP complianceContamination controlMicrobiological testingISO 1702521 CFR 211 knowledgeTraining developmentCommunicationAttention to detailOrganizational skillsTeam collaborationProblem-solving

Required

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
Well versed in CGMP guidelines, ISO 17025, and all USP microbiological testing
Ability to read and interpret various documents including safety instructions, standard operating procedures, technical procedures, and governmental regulations
Strong written and verbal communication skills
Effective presentation skills
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement
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
Strong technical foundation and proven capability in effectively utilizing diverse software tools
Adeptness in manufacturing and internet software
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
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

Preferred

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

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!

Company

Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.

H1B Sponsorship

Curia has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-03-07Debt Financing
2017-08-31Private Equity

Leadership Team

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Steve Lavezoli
Vice President, Biologics Division
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Company data provided by crunchbase