Chemist III

The NPI, Chemist III provides advanced analytical expertise and technical leadership within the Chemistry Department, with primary responsibility for supporting new product introduction (NPI), internal manufacturing, and external customer programs. This role independently performs and troubleshoots complex analytical testing and leads analytical workstreams for new products, including method assessment, development, transfer, verification, validation, laboratory readiness, protocol development, protocol execution, data interpretation, and report preparation.

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.
• 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.
• Serve as a subject matter expert for analytical testing, instrumentation, and NPI laboratory implementation; independently perform, develop, optimize, and troubleshoot complex testing using equipment such as balances, pipettes, pH meters, UV/Visible spectrophotometers, TOC analyzers, IR, HPLC, and related 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, risks, options, and recommendations to management, customers, and cross-functional teams.
• Author, review, approve where delegated, and execute analytical protocols and reports for method development, transfer, verification, validation, comparability, stability, feasibility, and new product laboratory implementation.
• Develop analytical strategies and protocol acceptance criteria that are scientifically justified, product appropriate, and aligned with approved specifications, regulatory commitments, compendial requirements, and customer agreements.
• Lead and provide technical direction for protocol execution, ensuring predefined requirements are followed, deviations are documented and assessed, data are reviewed contemporaneously, and conclusions are supported by objective evidence.
• Own technical assessment of 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 clear customer-facing presentations, data reviews, meeting updates, and written responses; document decisions, action items, technical risks, and follow-up commitments through established project and quality systems.
• Lead or support investigations involving deviations, problem reports, out-of-specification (OOS), and out-of-trend (OOT) results utilizing root cause analysis and risk assessment tools to identify corrective and preventive actions.
• Perform detailed data reviews and provide guidance and coaching on good documentation practices, error corrections, and compliance expectations.
• Provide technical training, mentorship, and cross-training to laboratory personnel on analytical methods, instrumentation, SOPs, and regulatory requirements while maintaining accurate training records.
• Serve as an NPI customer-facing analytical technical representative and collaborate with Quality, Manufacturing, Validation, Engineering, Project Management, external laboratories, and customers regarding project scope, analytical strategy, testing schedules, technical updates, investigations, risks, and deliverables.
• Plan and coordinate analytical activities performed internally and by external laboratories, including method readiness, sample and reference-standard requirements, technical transfers, data review, issue escalation, and delivery of customer and project commitments.
• Enter, review, track, and trend analytical data within applicable laboratory data management systems to support operational monitoring and continuous improvement initiatives.
• Lead analytical workstreams for NPI and cross-functional projects, including laboratory readiness assessments, resource and equipment planning, method gap assessments, protocol execution, risk management, customer-facing technical meetings, continuous improvement, and audit support.
• Be the point of contact for the chemistry labs with customers/clients on NPI teams, including technical discussions on protocols and issues pertaining to testing and product performance.
• Maintain a thorough understanding of pharmaceutical regulatory and compliance requirements and support inspection readiness through adherence to GMP, GLP, safety, and aseptic gowning requirements.
• Adhere to all company, safety, quality, and regulatory policies while promoting a compliant, safe, and quality-focused laboratory environment.
• Read/interpret SOPs to ensure compliance.
• Maintain up to date trainings.
• Other duties as assigned.

Education and/or Experience

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific field.
• Minimum of five (5) years experience in chemistry and NPI’s or related role.
• Minimum of five (5) years experience of aseptic/sterile experience in a pharmaceutical or related industry, preferred.

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.
• Demonstrates strong attention to detail.
• Proficient 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 independent work related to projects and/or routine activities.
• Ability to meet deadlines and work under pressure with limited supervision.
• Be accessible to laboratory and plant area(s) and office staff.
• Able to use required office equipment.

Other Qualifications

• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.
• May be required to obtain and maintain gowning certification.
• May be required to obtain and maintain media qualification.
• May be required to wear a respirator.