Analytical Method Development Specialist

3 weeks ago

San Diego, California, United States Actalent Full time
Job Title: Analytical Method Development Specialist

Job Summary:

We are seeking an experienced Analytical Method Development Specialist to join our team at Actalent. As an Analytical Method Development Specialist, you will be responsible for developing, validating, and transferring analytical methods for peptide projects.

Key Responsibilities:

  • Develop and validate HPLC, gas chromatography, and mass spectrometry methods for peptide projects.
  • Translate technical information and requirements into experimental design.
  • Generate, review, and execute phase-appropriate method validation/verification/transfer protocols.
  • Prepare documentation in support of method qualification or validation results.
  • Perform troubleshooting during method qualification or validation.
  • Perform data analysis, interpretation, and review using statistical methods.
  • Prepare summaries and reports.
  • Compile and track undesirable/unacceptable problems encountered during analytical method execution.
  • Write, review, and assist in the evaluation of the effectiveness of SOPs and identify necessary changes following validation activities.
  • Assist in the maintenance of validation/verification/transfer documents.
  • Assist in writing risk analysis (or statistical analysis) as part of validation activities.
  • Monitor and track validation/verification/transfer activities.
  • May assist with training, competency assessment, and performance evaluations of laboratory personnel as appropriate.
  • Investigate deviations in validation protocols, identify the root cause of the deviation, issue corrective and preventive actions, and carry out follow-up once the actions are implemented to ensure their effectiveness.
  • Work closely with AD to ensure accurate transfer of methods from AD to QC.
  • Work closely with QC to ensure accurate scheduling of instrumentation and validation activities.
  • Work closely with QA to ensure documents are reviewed and approved in a timely manner.
  • Work closely with Project Management and the Account Manager to ensure that customer expectations with respect to method validation and transfers are met.
  • Work closely with Regulatory Department to ensure that information is pertinent to method validation are transparent to regulatory.
  • Offer expertise to other departments of the company such as Production, Maintenance, Quality, Engineering, and Analytical Services.
  • Plan and coordinate the activities required as part of the validation protocol with the departments of Production, Maintenance, Quality, Engineering, and Stability.
  • Responsible for continuous evaluation/optimization of test methods for efficiency and cost reduction.

Requirements:

  • BS or MS in Analytical Chemistry or equivalent.
  • 3-5 years experience in HPLC method development.
  • Peptide experience preferred.
  • Strong technical knowledge of GC and MS method development preferred.
  • Proficient use of Microsoft Office suite of applications (Outlook, Excel, Word, PowerPoint, Teams, etc.).
  • Ability to work as part of a team and also independently with minimal to no supervision.
  • Ability to rapidly change focus during times of shifting or changing priorities.
  • Impeccable technical writing skills with extreme attention to detail, specifically the lexicology and grammatology of written English text as applied to technical writing.
  • Excellent organizational, multitasking, and communication skills.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion:

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent.
  • Maintaining an inclusive environment through persistent self-reflection.
  • Building a culture of care, engagement, and recognition with clear outcomes.
  • Ensuring growth opportunities for our people.

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 for other accommodation options.

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