NPI Microbiologist 4

Senior Microbiologist, NPI 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!
 

As a member of the NPI Tech Transfer Team, this position is responsible for supporting New Product Introduction (NPI) and technology transfer activities within their assigned functional area (e.g., Quality, Technical Operations, Validation, Microbiology, Analytical Sciences, Manufacturing, etc.). This role serves as the primary Subject Matter Expert (SME) for the functional area throughout the NPI lifecycle, providing technical leadership, risk assessment, planning, execution support, and operational readiness to ensure successful transfer and efficient commercialization of new products.
Working as a core member of the NPI Tech Transfer Team, the SME collaborates closely with Program Management, Operations, Quality, Regulatory, as a member of the customer-facing team, working to drive project execution through Tech Transfer stage gates, facilitate knowledge transfer, identify and mitigate risks, and ensure compliance with site procedures, regulatory requirements, and customer expectations. The position is dedicated to NPI activities and serves as the functional customer-facing point of contact for multiple concurrent tech transfer programs.
The NPI, Microbiologist IV provides advanced microbiological expertise and technical leadership in support of new product introduction (NPI), routine manufacturing, product release, contamination control, and external customer programs. This role leads microbiological workstreams for new products, including method and specification assessment, analytical strategy, protocol development, scientifically justified acceptance criteria, protocol execution, data interpretation, and report preparation. The NPI, Microbiologist IV serves as a customer-facing technical representative for microbiology activities and communicates project status, technical risks, investigation outcomes, and recommendations in coordination with Quality and Project Management. The role leads or supports microbiological method transfer, verification, validation, qualification, suitability, recovery, hold-time, disinfectant effectiveness, and laboratory readiness activities; authors and reviews controlled technical documents; coordinates internal and external laboratory testing; mentors laboratory personnel; and ensures microbiological documentation is accurate, complete, data-integrity compliant, and inspection ready.

Essential Duties and Responsibilities:
•    Act as the designated functional SME for all 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 required 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 in accordance with established procedures and project timelines. 
•    Drive operational readiness activities necessary to support development, validation, and commercial manufacturing. 
•    Support knowledge transfer activities between sending and receiving organizations, ensuring effective and efficient transfer of process, product, analytical, and operational knowledge. 
•    Participate in Technical Review Boards (TRBs), stage gate reviews, and leadership governance meetings. 
•    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 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 to management, customers, and cross-functional teams.
•    Provide technical leadership for microbial identification, organism trending, environmental and personnel monitoring, media fill support, line clearance, start-up verification, and assessment of isolates or recoveries.
•    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 the microbiological technical assessment and strategy for assigned NPI programs, including applicable 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 aligned with applicable specifications, regulatory, compendial, contamination-control, and customer requirements.
•    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 cross-functional teams to support 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.

Education and/or Experience:    
•    Bachelor’s degree in microbiology, Biology, or a related scientific discipline.
•    Minimum of eight (8) years’ relevant professional experience in a pharmaceutical GMP or GLP environment.
•    Proficient in the validation/qualification of lab microbiological techniques, preferred. 
•    Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485, and 17025 a plus.

Supervisory Responsibilities:
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Other Skills and Abilities:        
•    Provides guidance and mentorship to team members
•    Fosters a collaborative and positive work environment
•    Champions change
•    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
•    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  
•    Strong organizational skills and ability to prioritize and multi-task in a fast-paced environment.

Other Qualifications:
Must pass a background check
Must pass a drug screen 
May be required to obtain and maintain gowning certification 
May be required to obtain and maintain media qualification 
Must be able to wear a respirator

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.