Senior Microbiologist

Curia • Albuquerque, NM

2d

About The Position

Curia is a global contract development and manufacturing organization (CDMO) that partners with pharmaceutical and biotechnology companies to provide treatments to patients. The Senior Microbiologist, NPI is part of the NPI Tech Transfer Team and serves as the functional subject matter expert for microbiology across assigned new product introduction and technology transfer programs. The role provides technical leadership, risk assessment, planning, execution support, and operational readiness from project initiation through commercial launch, while working with Program Management, Operations, Quality, Regulatory, customers, and other functions.

The position provides advanced microbiological expertise for new product introduction, routine manufacturing, product release, contamination control, and external customer programs. It leads microbiology workstreams for new products, including method and specification assessment, analytical strategy, protocol development and execution, acceptance criteria, data interpretation, and report preparation. The role also leads or supports microbiological method transfer, verification, validation, qualification, suitability, recovery, hold-time, disinfectant effectiveness, and laboratory readiness activities.

The Senior Microbiologist is a customer-facing technical representative for microbiology and communicates project status, technical risks, investigation outcomes, and recommendations in coordination with Quality and Project Management. The role 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 requirements, and inspection ready. The position has no supervisory responsibilities, though it may involve mentoring, guiding, and advising.

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 attention to detail.
• Strong organizational skills and ability to prioritize and multitask in a fast-paced environment.
• Must pass a background check.
• Must pass a drug screen.
• Must be able to wear a respirator.

Nice To Haves

• Proficiency in validation or qualification of laboratory microbiological techniques.
• Knowledge of ISO 9001, ISO 13485, and ISO 17025.
• May be required to obtain and maintain gowning certification.
• May be required to obtain and maintain media qualification.

Responsibilities

• Act as the designated functional subject matter expert for assigned NPI and technology transfer projects.
• Participate in cross-functional Tech Transfer teams from project initiation through commercial launch.
• Lead discipline-specific assessments, gap analyses, risk evaluations, and readiness reviews.
• Support development and execution of project plans, timelines, and deliverables for Tech Transfer stage gates.
• Provide technical expertise during customer meetings, technical discussions, audits, and governance reviews.
• Partner with Program Managers to identify project risks, mitigation plans, and escalation pathways.
• Ensure functional deliverables, documentation, and approvals are completed according to procedures and project timelines.
• Drive operational readiness for development, validation, and commercial manufacturing.
• Support knowledge transfer between sending and receiving organizations for process, product, analytical, and operational knowledge.
• Participate in Technical Review Boards, stage-gate reviews, and leadership governance meetings.
• Collaborate across functions to resolve technical challenges and remove execution barriers.
• Contribute to improvement of NPI and Tech Transfer processes, tools, templates, and best 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; evaluate method performance and product or facility risks; and communicate findings and recommendations.
• Provide technical leadership for microbial identification, 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 methods, specifications, sample plans, materials, equipment, software, capacity, external laboratory support, and analyst qualification requirements.
• Own microbiological technical assessments and strategies for assigned NPI programs, considering regulatory, compendial, product, facility, contamination-control, and customer requirements.
• 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.
• Lead protocol execution, ensuring requirements are followed, deviations are assessed, data is reviewed, and conclusions are supported by objective evidence.
• Collaborate with NPI, Manufacturing, Quality, Validation, Engineering, Project Management, and other teams on product onboarding, testing, technical issue resolution, and project schedules.
• Coordinate internal and external laboratory microbiological activities, 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, and champion change.
• Promote a safe and healthy work environment by identifying and addressing hazards, following safety protocols, participating in safety training, and fostering awareness and responsibility.
• Facilitate revision and release of controlled documents and mandatory SOP reviews and month-end reports.
• Provide oversight for projects to update or maintain official document templates and direct and manage the Change Control System.
• Organize, prioritize, and manage multiple tasks in a fast-paced environment.

Benefits

• Generous benefit options, eligible 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