Chemist III

Curia•Albuquerque, NM
•Onsite

About The Position

The NPI Chemist III supports new product introduction (NPI), technology transfer, internal manufacturing, and external customer programs within Curia’s Chemistry Department. As the designated analytical subject matter expert, the role provides technical leadership throughout technology transfer and commercialization, from method assessment and development through transfer, verification, validation, laboratory readiness, execution, data interpretation, and reporting. The Chemist III independently performs and troubleshoots complex analytical testing and leads analytical workstreams for multiple concurrent programs. This customer-facing role works closely with Program Management, Operations, Quality, Regulatory, Manufacturing, Validation, Engineering, external laboratories, and customers. It communicates project status, technical risks, investigation outcomes, and recommendations; supports project stage gates and operational readiness; and facilitates knowledge transfer. The role authors, reviews, approves where delegated, and executes analytical documentation, while ensuring records are complete, accurate, data-integrity compliant, and inspection ready. The position also supports investigations, regulatory inspections, continuous improvement, and the training and mentorship of laboratory personnel. The Chemist III is expected to maintain compliance with applicable cGMP, GLP, safety, aseptic gowning, and regulatory requirements. The role has no supervisory responsibilities, though it may involve mentoring, guiding, and advising others.

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, data interpretation, and technical documentation capabilities, as reflected in the role’s duties.
  • Ability to perform independent project or routine work, interpret written, oral, diagram, or schedule instructions, and meet deadlines under pressure with limited supervision.
  • Strong attention to detail and proficiency with the operation of common laboratory equipment.
  • Ability to use required office equipment and be accessible to laboratory, plant, and office staff.
  • Must pass a background check and drug screen.
  • May be required to pass Occupational Health Screening, obtain and maintain gowning certification and media qualification, and wear a respirator.

Nice To Haves

  • At least five years of aseptic or sterile experience in the pharmaceutical or a related industry (preferred).

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, readiness reviews, and analytical workstreams for NPI and cross-functional projects.
  • Support project plans, timelines, stage-gate deliverables, operational readiness, and knowledge transfer between sending and receiving organizations.
  • Provide analytical expertise during customer meetings, technical discussions, audits, governance reviews, and presentations; communicate project status, risks, findings, recommendations, decisions, and follow-up commitments.
  • Partner with Program Managers and cross-functional teams to identify project risks, mitigation plans, escalation pathways, and solutions to technical challenges.
  • Perform, develop, optimize, and troubleshoot complex analytical testing and instrumentation; perform and review testing of raw materials, in-process samples, finished products, stability samples, water, and particulates.
  • Analyze, interpret, trend, and summarize analytical data; assess method performance and product-specific risks; and provide scientifically sound findings and recommendations.
  • Author, review, approve where delegated, and execute analytical protocols and reports for method development, transfer, verification, validation, comparability, stability, feasibility, and laboratory implementation.
  • Develop analytical strategies and scientifically justified protocol acceptance criteria aligned with specifications, regulatory commitments, compendial requirements, and customer agreements.
  • Lead 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.
  • Lead or support deviation, problem report, OOS, and OOT investigations using root-cause analysis and risk assessment to identify corrective and preventive actions.
  • Review analytical data and coach personnel on good documentation practices, corrections, and compliance expectations.
  • Train, mentor, and cross-train laboratory personnel, including other analysts and NPI chemists, on methods, instrumentation, SOPs, and regulatory requirements; maintain training records.
  • Plan and coordinate analytical activities performed internally and by external laboratories, including method readiness, sample and reference-standard needs, transfers, data review, issue escalation, and delivery of commitments.
  • Enter, review, track, and trend analytical data in applicable laboratory data management systems.
  • Support inspections and continuous improvement of NPI and technology transfer processes, tools, templates, and best practices.
  • Maintain compliance with pharmaceutical regulatory requirements, GMP, GLP, safety, aseptic gowning, company policies, and SOPs; maintain current training and promote a safe, quality-focused laboratory environment.
  • Perform other duties as assigned.

Benefits

  • Generous benefit options, available beginning on 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.
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