Method Development and Validation Chemist

2 weeks ago

Woodstock, Georgia, United States Woodstock Sterile Solutions Full time
Job Summary

Woodstock Sterile Solutions is seeking a highly skilled and experienced Method Development and Validation Chemist to support our analytical chemistry method development and validation projects. The successful candidate will have a strong background in analytical chemistry and experience in method development, validation, and transfer.

Key Responsibilities
  • Develop and validate analytical methods for raw materials, including Active Pharmaceutical Ingredient (API) and finished products.
  • Work directly with customers on analytical methods, including method development and optimization, transfer, and verification.
  • Support API and FP release testing and peer review once method implementation is complete.
  • Define experimental designs for analytical method development and optimization.
  • Define required laboratory equipment and instruments and onboard instruments as needed.
  • Define project scope for method transfers, validation, and verifications.
  • Guide and author chemistry investigations and non-routine events.
  • Author standard operating procedures for new equipment and/or test methods.
  • Act as technical subject matter expert on multi-disciplinary project teams.
  • Ensure that key technical milestones with internal and external stakeholders are achieved so that the overall project can progress in a timely manner.
  • Communicate changes and risks with project managers, internal team members, and customers, as required.
Requirements
  • Bachelor of Science in Chemistry or relevant discipline required.
  • Minimum of 7 years relevant experience in a cGMP and/or pharmaceutical manufacturing environment or combination of lower experience with strong academic experience.
  • Extensive experience with HPLC is required.
  • Experience with GC and GC/MS is required.
  • Experience with particle size distribution analysis is beneficial.
  • Strong experience with analytical method development, validation, and transfers.
  • Proficient in multiple laboratory techniques and demonstrates an in-depth understanding of one or more core laboratory techniques.
  • Should be familiar with applicable regulatory guidelines and USP monographs.
  • Strong experience with HPLC analysis. Empower experience is preferred.
  • Strong experience with wet chemistry and laboratory techniques.
  • General experience with instrumentation for testing of chemical and physical attributes.
  • Problem-solving skills, analytical skills, and a high level of attention to detail required.
  • Excellent documentation skills.
  • Excellent communication skills both written and oral at all levels within the organization.
  • A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.).
  • Must possess appropriate communication skills to interface with both technical and non-technical customer representatives.
  • Must possess appropriate communication skills allowing direct interaction with outside suppliers, WSS internal Managers, and Sr. Management.
  • Ability to work independently and/or in a team environment on multiple projects.
  • Ability to be flexible and adapt to ever-changing expectations/priorities.
  • Should be familiar with USP chapters 1224 and 1225 for method transfer and validation.
  • Should be familiar with cGxP or be able to quickly learn and apply cGxP principles and must be able to follow safe work practices.
  • Demonstrate a willingness to share skills and information with others.
  • Blend knowledge and analysis with logic and active listening. Act ethically.
  • Demonstrate a bias toward action. Be a vocal contributor to project teams, helping to guide the project direction and execution. Foster teamwork to get results.
  • Demonstrated ability to read, write, and speak clear English.
Physical Requirements
  • Ability to work with various chemicals including potent compounds.
  • Ability to stand for up to 8 hours per day on occasion.
  • Frequent sitting, standing, reading of written documents, and use of computer monitor screen.

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