Analytical Development Principal Scientist

Job Description

Job Description

Analytical Development Principal Scientist

Job Description

The Analytical Development Principal Scientist develops, validates, and implements robust analytical methods for raw materials, intermediates, and finished pharmaceutical products, with a focus on small molecule active pharmaceutical ingredients (APIs). This role performs complex analytical testing using advanced instrumentation, supports method development and tech transfer activities, and collaborates closely with development and quality control teams to ensure data integrity and regulatory compliance. The Principal Scientist also mentors other chemists, contributes to continuous improvement initiatives, and plays a key role in scaling processes to commercial manufacturing within a regulated CDMO/CRO environment.

Responsibilities

• Develop, validate, and implement analytical methods for raw materials, intermediates, and finished products, with emphasis on small molecule API development.
• Perform analytical testing using HPLC, GC, GC/MS, FTIR, particle size analysis, and other relevant laboratory instrumentation.
• Execute and support method development for compound identification, purity determination, and potency assays.
• Interpret analytical data, draw scientifically sound conclusions, and document results in detailed technical reports and laboratory notebooks.
• Ensure strict compliance with GMP, SOPs, DEA regulations, and other applicable regulatory requirements in all laboratory activities.
• Transfer validated analytical methods to Quality Control and Process Support teams, ensuring clear documentation and effective knowledge transfer.
• Advise internal and external stakeholders on analytical results, method performance, and technical transfer considerations.
• Mentor and provide technical guidance to other chemists within the department, fostering skill development and best practices.
• Support sample analysis for development projects, including planning, prioritizing, and coordinating external testing when needed.
• Qualify reference standards, maintain accurate laboratory documentation, and uphold data integrity throughout all analytical workflows.
• Maintain robust document control practices within a GMP environment, including assay records, method validation documentation, and quality control data.
• Collaborate cross-functionally with development, QC, and manufacturing teams to troubleshoot analytical issues and support process optimization.
• Contribute to continuous improvement initiatives in analytical development, laboratory operations, and documentation practices.
• Demonstrate the ability to transfer processes to commercial scale manufacturing, ensuring analytical methods are suitable for production environments.
• Participate in additional laboratory and technical support activities as required to meet project and organizational objectives.

Essential Skills

• Extensive hands-on experience with HPLC, GC, GC/MS, FTIR, and particle size analysis in an analytical chemistry laboratory.
• Strong experience in analytical chemistry and analytical development, particularly for small molecule API and Active Pharmaceutical Ingredient development.
• Proven experience working within a CDMO or CRO environment and familiarity with associated operational and regulatory requirements.
• Demonstrated expertise in GMP-compliant laboratory operations, including document control, assay execution, method validation, and quality control.
• In-depth knowledge of GMP and DEA regulations and the ability to maintain compliance in all analytical activities.
• Ph.D. in Chemistry or related field with a minimum of 8 years of relevant experience, or M.S. in Chemistry or related field with a minimum of 10 years of relevant experience, or a bachelor’s degree in Chemistry or related field with 12 years of experience in a laboratory environment (pharmaceutical experience preferred).
• Demonstrated ability to transfer analytical processes and methods to commercial scale manufacturing settings.
• Excellent verbal and written communication skills, with the ability to clearly present technical data and collaborate across diverse teams.
• Strong interpersonal and organizational skills, with the ability to work effectively in a diverse, cross-functional team environment.
• Proven ability to maintain high standards of data integrity, documentation accuracy, and regulatory compliance.

Additional Skills & Qualifications

• Ph.D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 12 years of experience in lab environment, pharmaceutical experience preferred.
• Experience in API development and small molecule Active Pharmaceutical Ingredient projects within a regulated pharmaceutical environment.
• Experience in method validation, including design, execution, and documentation of validation protocols and reports.
• Familiarity with quality control principles, laboratory best practices, and continuous improvement methodologies.
• Experience coordinating external analytical testing and managing relationships with third-party laboratories.
• Ability to mentor junior scientists and chemists, providing technical guidance and supporting career development.
• Strong problem-solving skills with the ability to troubleshoot complex analytical and process-related issues.
• Comfort working within structured document control systems and following established SOPs in a GMP environment.
• Pharmaceutical industry experience is preferred, particularly in development and scale-up of commercial manufacturing processes.

This is a Permanent position based out of Charles City, IA.

The pay range for this position is $107856.00 - $126673.00/yr.

PTO Holiday Pay Health, dental, vision insurance

This is a fully onsite position in Charles City,IA.

This position is anticipated to close on Jul 13, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.