Scientist/Sr. Scientist, Analytical Technologies
The candidate will provide technical leadership and “hands-on” laboratory work to support the Axcella project team, including timely execution of analytical methods, transfer of methods to contract research and manufacturing organizations, method development qualification/validation, design and execution of stability indicating methods, and retesting of analytical reference standards.
KEY TASKS AND RESPONSIBILITIES:
- Develop new and/or improved analytical methods, biological potency assays for new and existing small molecule products and processes.
- Validate analytical methods for raw material, API and final product release, in-process controls, process analytical technologies and stability testing.
- Prepare qualification/validation protocols, conduct test method qualification/validation work and prepare qualification/validation reports.
- Execute reference standard qualifications and prepare reports.
- Provide analytical support for QC projects, as necessary.
- Work with multidisciplinary technology teams.
- Perform appropriate testing and data evaluation for the development and justification of release specifications.
- Coordinate instrument qualification, maintenance, repair activities and maintain instrument logs and records.
- Operate in compliance with current Good Manufacturing Practices, as necessary, Good Laboratory Practices and use applicable ICH and FDA requirements.
- Maintain supplies and materials for laboratory area.
- Assist in the evaluation and cost estimates for new projects and capital equipment.
- Document results in accordance with internal SOP’s.
- Implement analytical methods to elucidate the types and quantities of impurities present in reaction mixtures, process streams, waste streams, intermediates and raw material, API and finished products.
- Conduct all job responsibilities in a manner consistent with all applicable safety and environmental laws and regulations
SKILLS AND ATTRIBUTES:
- Technical competency and practical working knowledge of the operation/maintenance of common analytical laboratory instruments, such as, HPLC, LC/MS, multimodal plate readers, tissue culture biosafety cabinets and biological assay instrumentation (SDS PAGE, Western Blotting, etc.).
- Willing to develop expertise in statistics, statistical design of experiments, Process Analytical Technology and QbD experimentation,
- Possess the ability to learn new processes, streamline processes and operational plans, act as “in-house” technical subject matter expert and apply broad technical knowledge to solve varying problems of high complexity.
- Demonstrate problem solving and analytical report writing, computer literacy including CFR Part11 Compliancy, familiarity with Documentum or Veeva software
- Excellent verbal and written communication skills, oral presentations as well as planning and time management skills.
EDUCATION AND EXPERIENCE:
Ph.D. in analytical chemistry, biochemistry or biology, with 0 to 5 years of relevant experience, MS with at least 5 to 10 years of relevant experience and demonstration of increased levels of responsibilities, BS with greater than 10 years of relevant experience and demonstration of increasing levels of responsibilities.
If interested, we would welcome a cover letter and CV sent to email@example.com No phone calls please, and only those we will be following up with, will receive a reply.