Chemist II

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.

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.
• Independently perform routine and moderately complex analytical testing of raw materials, in-process samples, finished products, stability samples, plant water, and particulate samples.
• 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.
• Support laboratory readiness assessments for new products.
• Perform feasibility or familiarization testing under approved plans and escalate 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.
• Review laboratory documentation, analytical data, and test results for accuracy, completeness, and compliance.
• Enter and maintain analytical data within applicable laboratory data management systems and perform data review activities.
• Participate in the development, review, and revision of analytical methods, specifications, worksheets, standard operating procedures (SOPs), protocols, and supporting laboratory documents.
• Train and provide guidance to less experienced laboratory personnel on analytical methods, equipment operation, procedures, and laboratory practices.
• Participate in internal and external training programs to maintain technical knowledge, regulatory awareness, and proficiency.
• 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.
• 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.
• 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 three (3) year experience in chemistry and NPI's or related role.
• Minimum of two (2) years experience of aseptic/sterile experience in a pharmaceutical or related industry, preferred.

Other Skills and Abilities

• Leads with integrity and respect.
• Provides guidance, coaching, and mentorship to team members.
• Demonstrates business acumen.
• Fosters a collaborative and positive work environment.
• Champions change.
• Coaches and Develops.
• 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 and 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.