Senior Microbiologist

Curia • Albuquerque, NM

2d

About The Position

Curia is seeking a Senior Microbiologist, NPI in Albuquerque, New Mexico. As a member of the NPI Tech Transfer Team, this role supports new product introduction and technology transfer, serving as the functional subject matter expert throughout the NPI lifecycle. The position provides technical leadership for risk assessment, planning, execution, knowledge transfer, and operational readiness, helping ensure successful transfer and commercialization of new products in compliance with site procedures, regulatory requirements, and customer expectations. It is dedicated to NPI activities and serves as a customer-facing microbiology contact for multiple concurrent technology transfer programs.

The NPI Microbiologist IV provides advanced microbiological expertise for new product introduction, routine manufacturing, product release, contamination control, and customer programs. The role leads microbiology workstreams, including method and specification assessment, analytical strategy, protocol development and execution, data interpretation, and report preparation. It also leads or supports microbiological method transfer, verification, validation, qualification, suitability, recovery, hold-time, disinfectant effectiveness, and laboratory-readiness activities. The position authors and reviews controlled technical documents, coordinates internal and external laboratory testing, mentors laboratory personnel, and ensures documentation is accurate, complete, compliant with data-integrity expectations, and inspection ready.

The position works closely with Program Management, Operations, Quality, Regulatory, Manufacturing, Validation, Engineering, and other teams. It participates in customer meetings, audits, technical discussions, governance reviews, and Tech Transfer stage-gate activities, communicating project status, risks, investigation outcomes, and recommendations. The role has no supervisory responsibilities, although it may mentor, guide, and advise others. Candidates must pass a background check and drug screen; gowning or media qualification may be required, and the role requires the ability to wear a respirator.

Requirements

• Bachelor’s degree in microbiology, biology, or a related scientific discipline.
• At least eight years of relevant professional experience in a pharmaceutical GMP or GLP environment.
• Knowledge of FDA cGMPs (21 CFR 211).
• Strong organizational skills and ability to prioritize and multitask in a fast-paced environment.
• Strong attention to detail.
• Ability to pass a background check and drug screen.
• Ability to wear a respirator.
• Must obtain and maintain gowning certification and media qualification if required.

Nice To Haves

• Proficiency in validation or qualification of laboratory microbiological techniques is preferred.
• Knowledge of ISO 9001, ISO 13485, and ISO 17025 is a plus.

Responsibilities

• Act as the designated functional subject matter expert for assigned NPI and technology transfer projects, participating in cross-functional teams from project initiation through commercial launch.
• Lead discipline-specific assessments, gap analyses, risk evaluations, and readiness reviews; support project plans, timelines, stage-gate deliverables, and operational readiness.
• Provide microbiology expertise in customer meetings, technical discussions, audits, governance reviews, and Technical Review Boards; communicate project status, risks, investigation outcomes, and recommendations.
• Partner with Program Managers to identify risks, mitigation plans, and escalation pathways, and ensure functional deliverables, documentation, and approvals meet procedures and project timelines.
• Support knowledge transfer between sending and receiving organizations and collaborate with cross-functional departments to resolve technical challenges and remove execution barriers.
• Contribute to continuous improvement of NPI and Tech Transfer processes, tools, templates, and practices.
• Lead and perform NPI microbiological testing, including endotoxin, sterility, bioburden, microbial limits, growth promotion, biological indicators, utilities, environmental monitoring, and applicable product-specific assays.
• Analyze, trend, and interpret microbiological data; assess method performance and product or facility risks; and communicate findings and recommendations to management, customers, and cross-functional teams.
• Provide technical leadership for microbial identification and organism trending, environmental and personnel monitoring, media fill support, line clearance, start-up verification, and isolate or recovery assessment.
• Lead microbiological method and laboratory-readiness assessments for new products, including assessment of methods, specifications, sample plans, materials, equipment, software, capacity, external laboratory support, and analyst qualifications.
• Own the microbiological technical assessment and strategy for assigned NPI programs, taking applicable regulatory, compendial, product, facility, contamination-control, and customer requirements into account.
• Author, review, approve where delegated, and execute protocols and reports for microbiological method development, transfer, verification, validation, qualification, suitability, recovery, neutralization, hold-time, disinfectant effectiveness, environmental monitoring, and new-product laboratory implementation.
• Develop scientifically justified protocol objectives, study designs, sample plans, challenge conditions, and acceptance criteria aligned with applicable specifications and regulatory, compendial, contamination-control, and customer requirements.
• Lead protocol execution, ensure requirements are followed, assess deviations, review data, and ensure conclusions are supported by objective evidence.
• Collaborate with NPI, Manufacturing, Quality, Validation, Engineering, Project Management, and other teams on product onboarding, testing requirements, technical issue resolution, and project schedules.
• Coordinate microbiological activities performed internally and by external laboratories, including technical transfer, sample and material requirements, scheduling, data review, issue escalation, and project commitments.
• Provide technical mentorship, training, and coaching to microbiology personnel on methods, protocol execution, investigations, data integrity, aseptic practices, and regulatory expectations.
• Lead or provide technical direction for OOS, sterility, bioburden, endotoxin, environmental monitoring, contamination, and method-performance investigations using root cause analysis, risk assessment, and CAPA.
• Support lifecycle management and implementation of microbiology laboratory equipment, technologies, methods, materials, supplies, and inventory while maintaining laboratory organization, housekeeping, and audit readiness.
• Provide guidance and mentorship to team members, foster a collaborative and positive work environment, champion change, and promote workplace safety.
• Facilitate revision and release of controlled documents and mandatory SOP reviews and month-end reports; oversee updates and maintenance of official document templates and direct and manage the Change Control System.

Benefits

• Generous benefit options, available from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior