Chemist III

CuriaAlbuquerque, NM
Onsite

About The Position

The Chemist III provides advanced analytical testing and technical leadership within the Chemistry Department supporting internal manufacturing and external customer programs. The laboratory performs testing of raw materials, in-process samples, finished products, stability samples, plant water, and particulates to support manufacturing and quality operations. This role independently performs and troubleshoots complex analytical testing using a variety of laboratory instrumentation, ensuring compliance with approved methods, specifications, and regulatory requirements. The Chemist III interprets and evaluates data, leads or supports method transfers, validations, investigations, and new product onboarding, and ensures accuracy and integrity of all analytical documentation. In addition, the Chemist III serves as a technical resource, providing mentorship and training to junior staff, authoring and reviewing technical documents, and collaborating cross-functionally with Quality, Manufacturing, Validation, Engineering, and customers. The role also supports continuous improvement initiatives, regulatory inspections, and maintains a state of GMP/GLP compliance and inspection readiness.

Requirements

  • Bachelor’s degree in Science, Chemistry, Biology or related field of study
  • Minimum of five (5) years experience in chemistry
  • Minimum of five (5) years experience in a pharmaceutical or aseptic/sterile related industry
  • Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.
  • Strong written and verbal communication skills, along with effective presentation skills.
  • Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages.
  • Strong grasp of algebraic and geometric principles.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions.
  • Adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
  • 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.
  • Ability to work effectively under pressure to meet deadlines.
  • Be accessible to laboratory and plant area(s) and office staff
  • Able to use required office equipment.
  • Must pass a background check
  • Must pass a drug screen
  • May be required to pass Occupational Health Screening

Responsibilities

  • Serve as a subject matter expert for analytical testing, instrumentation, and laboratory processes, independently performing and troubleshooting complex testing activities 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; compile technical summaries and communicate findings, risks, and recommendations to management and cross-functional teams.
  • Execute, author, review, and provide technical input for protocols, reports, investigations, change controls, data summaries, and laboratory documentation to ensure accuracy, compliance, and data integrity.
  • 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, aseptic practices, and regulatory requirements while maintaining accurate training records.
  • Collaborate with Quality, Manufacturing, Validation, Engineering, external laboratories, and customers regarding testing schedules, technical updates, investigations, and project support activities.
  • Coordinate testing activities performed by external laboratories and support raw material and customer-related testing requirements.
  • Maintain, sanitize, troubleshoot, and support lifecycle activities for laboratory equipment and cleanroom areas while assisting with evaluation and implementation of new equipment, technologies, and procedures.
  • Enter, review, track, and trend analytical data within applicable laboratory data management systems to support operational monitoring and continuous improvement initiatives.
  • Lead departmental and cross-functional projects, including continuous improvement initiatives, new product onboarding activities, audit support, and customer-facing interactions.
  • 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

Benefits

  • Generous benefit options (eligible first day of employment)
  • Paid training, vacation and holidays (vacation accrual begins on first day of employment)
  • Career advancement opportunities
  • Education reimbursement
  • 401K program with matching contributions
  • Learning platform
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