Chemist II

NPI Chemist II in Albuquerque, NMBuild your future at Curia, where our work has the power to save livesCuria 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 opportunitiesEducation reimbursement401K program with matching contributionsLearning platformAnd moreAs 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 Chemist II performs routine and moderately complex analytical testing to support pharmaceutical manufacturing operations, customer requirements, and new product introduction (NPI) programs. This role independently conducts testing of raw materials, in-process materials, finished products, stability samples, plant water, and particulate samples using approved analytical methods and laboratory instrumentation. The NPI Chemist II executes approved protocols, supports analytical method transfer, verification and validation activities, evaluates and documents test results, and assists with implementation of new products into the laboratory. Responsibilities include identifying and investigating atypical findings, preparing accurate technical documentation, supporting equipment qualification, calibration, and maintenance, and reviewing laboratory records for accuracy and completeness in accordance with current Good Manufacturing Practices (cGMP), data integrity requirements, and applicable regulatory standards. The NPI Chemist II collaborates with cross-functional NPI teams, contributes to SOP and method revisions, supports continuous improvement, and serves as a technical resource to less experienced laboratory personnel. This role maintains audit readiness, performs work in accordance with aseptic gowning requirements, and complies with applicable DEA regulations, where required.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.Independently perform routine and moderately complex analytical testing of raw materials, in-process samples, finished products, stability samples, plant water, and particulate samples in accordance with approved procedures, validated methods, and regulatory requirements.Operate, troubleshoot, and maintain standard laboratory instrumentation, including balances, pipettes, pH meters, UV/Visible spectrophotometers, Total Organic Carbon (TOC) analyzers, and other applicable analytical equipment.Accurately document laboratory activities, test results, observations, and conclusions in accordance with Good Documentation Practices (GDP), data integrity requirements, and applicable quality standards.Execute approved analytical protocols for NPI, method transfer, method verification, method validation, stability, and laboratory implementation activities; accurately document execution, observations, deviations, and results.Support laboratory readiness assessments for new products, including review of analytical methods, specifications, sample requirements, reference standards, reagents, columns, consumables, equipment, software, and analyst training needs.Perform feasibility or familiarization testing under approved plans and escalate method, equipment, material, scheduling, or data-quality risks to the NPI Chemist III, supervisor, or project team.Prepare clear data summaries and contribute technical content to protocol reports, method transfer packages, investigations, change controls, and NPI status updates.Analyze and interpret analytical data, identify trends or atypical results, support laboratory investigations, and apply root cause analysis and risk assessment tools to assist with scientifically sound problem resolution.Review laboratory documentation, analytical data, and test results for accuracy, completeness, and compliance with established procedures.Enter and maintain analytical data within applicable laboratory data management systems and perform data review activities, including basic tracking and trending of results.Participate in the development, review, and revision of analytical methods, specifications, worksheets, standard operating procedures (SOPs), protocols, and supporting laboratory documents to enable compliant new product implementation.Train and provide guidance to less experienced laboratory personnel on analytical methods, equipment operation, procedures, and laboratory practices as needed.Participate in internal and external training programs to maintain technical knowledge, regulatory awareness, and proficiency in laboratory techniques and quality systems.Prepare laboratory supplies, equipment, and documentation required to support manufacturing activities and analytical testing operations.Assist with the qualification, evaluation, and implementation of new laboratory equipment, analytical procedures, and process improvements.Maintain laboratory equipment, organization, housekeeping, and audit readiness in accordance with Good Laboratory Practices (GLP), cGMP requirements, and company standards.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.Interact with customers/clients on NPI teams. Including technical discussions on protocols, and issues pertaining to testing and product performance.Maintain required DEA clearance and comply with applicable requirements for handling controlled substances, where applicable.Adhere to all safety, regulatory, quality, and company policies to ensure a compliant and safe working environment.Read/interpret SOPs to ensure complianceMaintain up to date trainingsOther duties as assignedEducation and/or Experience:Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific fieldMinimum of three (3) year experience in chemistry and NPI's or related roleMinimum of two (2) years experience of aseptic/sterile experience in a pharmaceutical or related industry, preferredOther Skills and Abilities:Leads with integrity and respectProvides guidance, coaching, and mentorship to team membersDemonstrates business acumenFosters a collaborative and positive work environmentChampions changeCoaches and DevelopsPromotes 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 detailProficient in the use of operational theories of all common laboratory equipment. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to perform