Chemist III

Curia • Albuquerque, NM

4d • Onsite

About The Position

The NPI Chemist III is a member of Curia’s NPI Tech Transfer Team and provides advanced analytical expertise and technical leadership for new product introduction, technology transfer, internal manufacturing, and external customer programs. The position serves as the designated functional subject matter expert and customer-facing analytical contact for multiple concurrent technology-transfer programs, supporting projects from initiation through commercial launch. The role collaborates with Program Management, Operations, Quality, Regulatory, Manufacturing, Validation, Engineering, external laboratories, and customers to facilitate knowledge transfer, assess and mitigate risks, support project execution through stage gates, and ensure operational readiness and compliance with site procedures, regulatory requirements, and customer expectations.

The Chemist III independently performs and troubleshoots complex analytical testing and leads analytical workstreams for new products. Responsibilities include method assessment, development, transfer, verification, validation, laboratory readiness, protocol development and execution, data interpretation, and report preparation. The role authors and reviews analytical documentation, coordinates internal and external laboratory activities, supports investigations and inspections, mentors laboratory personnel, and maintains accurate, complete, data-integrity-compliant, inspection-ready documentation. The position requires adherence to cGMP, GLP, safety, aseptic gowning, and applicable regulatory requirements.

The role has no supervisory responsibilities, but may mentor, guide, and advise team members. Additional duties may be assigned. Applicants must pass a background check and drug screen; occupational health screening, gowning certification, media qualification, or respirator use may also be required.

Requirements

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific field.
• At least five years of experience in chemistry and NPI or a related role.
• Strong analytical testing, instrumentation, method development, transfer, verification, validation, and troubleshooting expertise.
• Ability to interpret analytical data and communicate technical findings, risks, and recommendations to customers, management, and cross-functional teams.
• Experience authoring, reviewing, and executing analytical protocols, reports, methods, specifications, investigations, and technical documentation.
• Knowledge of pharmaceutical regulatory and compliance requirements, including GMP, GLP, data integrity, safety, and aseptic gowning requirements.
• Strong attention to detail and proficiency with the operation of common laboratory equipment.
• Ability to interpret written, oral, diagrammatic, or schedule-based instructions and work independently with limited supervision.
• Ability to meet deadlines and work effectively under pressure.
• Must pass a background check and drug screen.
• May be required to pass occupational health screening, obtain and maintain gowning certification or media qualification, and wear a respirator.
• Must be able to access laboratory, plant, and office areas and use required office equipment.

Nice To Haves

• At least five years of aseptic or sterile experience in the pharmaceutical or a related industry; preferred.
• Experience providing technical mentorship and guidance to laboratory personnel.
• Experience coordinating analytical activities with external laboratories and supporting regulatory inspections.

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, operational readiness, and knowledge transfer between sending and receiving organizations.
• Provide technical expertise in customer meetings, technical discussions, audits, governance reviews, Technical Review Boards, and stage-gate reviews.
• Partner with Program Managers to identify project risks, mitigation plans, and escalation pathways; collaborate across departments to resolve technical challenges and remove execution barriers.
• Ensure functional deliverables, documentation, and approvals are completed in accordance with procedures and project timelines.
• Contribute to continuous improvement of NPI and technology-transfer processes, tools, templates, and best practices.
• Serve as an analytical testing, instrumentation, and NPI laboratory implementation expert; independently perform, develop, optimize, and troubleshoot complex testing using laboratory instrumentation.
• Perform and review analytical testing of raw materials, in-process samples, finished products, stability samples, water, and particulates in accordance with approved methods, specifications, and regulatory requirements.
• Analyze, interpret, trend, and summarize analytical data; evaluate method performance and product-specific risks; and communicate scientifically sound findings and recommendations.
• Author, review, approve where delegated, and execute protocols and reports for method development, transfer, verification, validation, comparability, stability, feasibility, and new-product laboratory implementation.
• Develop analytical strategies and scientifically justified protocol acceptance criteria aligned with specifications, regulatory commitments, compendial requirements, and customer agreements.
• Lead and provide technical direction for protocol execution, ensuring requirements are followed, deviations are documented and assessed, data are reviewed contemporaneously, and conclusions are supported by objective evidence.
• Assess new-product methods, specifications, compendial requirements, sample plans, reference standards, columns, reagents, consumables, equipment, software, data systems, and analyst qualification needs before laboratory implementation.
• Prepare and deliver customer-facing presentations, data reviews, meeting updates, and written responses; document decisions, action items, risks, and follow-up commitments in established systems.
• Lead or support deviation, problem-report, out-of-specification, and out-of-trend investigations using root-cause analysis and risk-assessment tools to identify corrective and preventive actions.
• Perform detailed data reviews and coach personnel on good documentation practices, error corrections, and compliance expectations.
• Provide technical training, mentorship, and cross-training on analytical methods, instrumentation, SOPs, and regulatory requirements, and maintain accurate training records.
• Serve as the customer-facing analytical representative and coordinate with internal departments, external laboratories, and customers on project scope, analytical strategy, schedules, technical updates, investigations, risks, and deliverables.
• Plan and coordinate analytical work performed internally and by external laboratories, including method readiness, sample and reference-standard requirements, technical transfers, data review, issue escalation, and commitment delivery.
• Enter, review, track, and trend analytical data in applicable laboratory data-management systems.
• Lead analytical workstreams for NPI and cross-functional projects, including laboratory readiness, resource and equipment planning, method gap assessments, protocol execution, risk management, customer-facing meetings, continuous improvement, and audit support.
• Serve as the chemistry laboratory point of contact for NPI customers and clients, including technical discussions about protocols, testing issues, and product performance.
• Maintain understanding of pharmaceutical regulatory and compliance requirements and support inspection readiness through adherence to GMP, GLP, safety, and aseptic gowning requirements.
• Follow company, safety, quality, and regulatory policies; read and interpret SOPs; maintain current training; and promote a compliant, safe, quality-focused laboratory environment.
• Provide guidance and mentorship, foster collaboration, champion change, identify and address potential hazards, and follow safety protocols.
• Perform independent work, meet deadlines under pressure with limited supervision, remain accessible to laboratory, plant, and office personnel, and use required office equipment.

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.
• 401K program with matching contributions.
• Learning platform.

What This Job Offers

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