Senior Scientist

Actalent; Iowa (LA); On-site; USD 95,000 - 130,000; Full time

Job summary

Actalent is seeking a Senior Scientist to lead analytical development for APIs, raw materials, and finished products within a GMP-regulated environment. You will validate methods, interpret complex data, and work with cross-functional teams to ensure compliance and quality.

The role emphasizes method development, validation, and technology transfer, with opportunities for growth toward Principal Scientist. Strong expertise in HPLC, GC, MS, and related QA documentation is essential.

Qualifications

• Proven experience in analytical method development and validation for APIs, raw materials, and finished products.
• Hands-on expertise with HPLC, GC, GC/MS, FTIR, and mass spectrometry in a lab setting.
• Strong understanding of GMP regulations and DEA guidelines in a lab environment.
• Experience with document control and data integrity within GMP.
• Ability to lead investigations and manage timelines for major projects.

Responsibilities

• Develop, validate, and implement analytical methods for materials and products.
• Perform analytical testing using HPLC, GC, GC/MS, FTIR, MS.
• Coordinate cross-functional teams to troubleshoot issues and transfer methods to QA/Process Support.
• Draft and review technical documents, reports, and SOPs with high accuracy.
• Lead investigations related to deviations or out-of-spec results and maintain timelines.

Skills

Analytical method development

HPLC

GC

Mass spectrometry

GMP compliance

DEA guidelines

Documentation & data integrity

Cross-functional collaboration

Education

PhD in Chemistry

MS in Chemistry

BS in Chemistry

Tools

HPLC

GC

GC/MS

FTIR

Job description

Job Description

Job Description

Senior Scientist

Job Description

The Senior Scientist plays a key role in developing, validating, and implementing analytical methods to support raw materials, intermediates, and finished products within a GMP-regulated environment. This position focuses on analytical development for active pharmaceutical ingredients, method validation, and complex data interpretation, while collaborating closely with cross-functional teams. The role offers a clear growth path and serves as a stepping stone toward a Principal Scientist position.

Responsibilities

• Develop, validate, and implement robust analytical methods for raw materials, intermediates, and finished products.
• Perform analytical testing using HPLC, GC, GC/MS, FTIR, mass spectrometry, and other laboratory instrumentation.
• Execute and support method development for compound identification, purity assessment, and potency analysis.
• Collaborate cross-functionally with development, quality control, and process support teams to troubleshoot analytical issues and provide technical guidance.
• Interpret analytical data, draw scientifically sound conclusions, and document results in technical reports and laboratory notebooks.
• Ensure strict compliance with GMP, SOPs, and applicable regulatory requirements, including DEA guidelines.
• Transfer validated analytical methods to Quality Control and Process Support teams, ensuring effective knowledge transfer and documentation.
• Support sample analysis for development projects and coordinate external testing activities when necessary.
• Qualify and maintain reference standards, ensuring accurate calibration, traceability, and documentation.
• Maintain laboratory documentation, data integrity, and document control practices in accordance with GMP standards.
• Lead investigations related to analytical issues, deviations, or out-of-specification results and maintain timelines for key activities.
• Author and review technical documents, including reports and protocols, with a high level of accuracy and minimal errors.
• Draft new standard operating procedures (SOPs) with guidance as needed to support laboratory operations and compliance.
• Contribute to continuous improvement initiatives to enhance laboratory efficiency, data quality, and analytical capabilities.
• Support additional laboratory activities as required to meet project timelines and organizational objectives.

Essential Skills

• Proven experience in analytical method development and validation for raw materials, intermediates, and finished pharmaceutical products.
• Hands-on expertise with HPLC, GC, GC/MS, FTIR, and mass spectrometry in an analytical laboratory setting.
• Strong experience in analytical chemistry with the ability to apply fundamental principles to complex testing and data interpretation.
• Experience in active pharmaceutical ingredient (API) development and analytical development within a CDMO or CRO environment.
• Demonstrated ability to maintain compliance with GMP regulations and DEA requirements in a laboratory setting.
• Experience with document control and data integrity within a GMP-compliant environment.
• Proficiency in assay development, method validation, and routine laboratory operations.
• PhD in Chemistry with 4+ years of relevant industry experience, OR MS in Chemistry with 8+ years of relevant industry experience, OR BS in Chemistry with 12+ years of relevant industry experience.
• Ability to lead analytical investigations and manage timelines for key project activities.
• Ability to author and review technical documents, such as protocols, reports, and summaries, with minimal errors.
• Capability to draft new SOPs with appropriate guidance and alignment to regulatory and quality requirements.
• Good understanding of cross-functional principles, including organic chemistry and engineering, to effectively support interdisciplinary projects.

Additional Skills & Qualifications

• PhD in Chemistry with 4+ years of relevant industry experience, MS in Chemistry with 8+ years of relevant industry experience, Or BS in Chemistry with 12+ years of relevant industry experience
• Experience working in contract development and manufacturing (CDMO) or contract research (CRO) organizations.
• Familiarity with Active Pharmaceutical Ingredient Development and associated analytical requirements.
• Strong problem-solving skills and the ability to troubleshoot complex analytical and instrumentation issues.
• Effective collaboration skills to work closely with development, QC, and engineering teams.
• Attention to detail and commitment to maintainin