DirectJobHub
Jobs · Analyst · North Carolina

Associate Scientist, Analytical Chemistry

CHEManager International · Durham, NC · Yesterday
AnalystFull-time

About the role

A typical day includes performing analysis of drug substance and drug product for potential ophthalmic medicines, generating analytical data for new and existing methods, validating analytical methodology, executing stability studies, compiling laboratory data, assisting in the design and execution of clinical phase-appropriate method validation and stability protocols, and assisting in the authoring of regulatory documents.

Responsibilities

  • Perform analysis of drug substance and drug product for potential ophthalmic medicines
  • Generate analytical data for new and existing methods to troubleshoot issues
  • Analyze and evaluate materials and products at all stages of the pharmaceutical product development process
  • Develop and validate analytical methodology, including stability-indicating HPLC methods, GC methods, Karl Fischer for new drug substances and products
  • Execute stability studies to support the development of new drug substances or drug products
  • Compile laboratory data
  • Author technical documents such as method development/validation reports, stability reports, and certificates of analysis
  • Maintain laboratory records and provide peer review of laboratory data
  • Schedule work activities with supervision and maintain laboratory supplies and equipment
  • Write and/or review standard operating procedures pertaining to analytical testing and reporting
  • Conduct work in compliance with cGMP, safety, and regulatory requirements
  • Assist in authoring Regulatory documents
  • Monitor and evaluate completion of tasks and projects
  • May assist in budget preparation for laboratory equipment

Requirements

  • Bachelor's Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
  • The ability to fluently read, write, understand and communicate in English
  • Preferred Experience And Skills: Strong laboratory skills in analytical testing for small molecules, experience with HPLC/UPLC, GC, GC-with headspace, Karl Fischer, FT-IR, and other physical testing including pH, HIAC, viscosity, comfort in a fast-paced environment, goal-oriented with excellent communication (written and oral) and organizational skills, experience with Empower software and electronic notebook (ELN), experience with analysis and/or analytical development for sterile solutions is preferred
  • BS/BA in Chemistry or related discipline with at least 5-8 years of relevant experience

Qualifications

Must have strong laboratory skills in analytical testing for small molecules, experience with HPLC/UPLC, GC, GC-with headspace, Karl Fischer, FT-IR, and other physical testing including pH, HIAC, viscosity. Must be comfortable working in a fast-paced environment - able to rapidly flex activities and priorities. Must be goal-oriented with excellent communication (written and oral) and organizational skills. Must be able to work effectively in teams. Must be able to conduct work in compliance with cGMP, safety, and regulatory requirements.

Skills

  • Strong laboratory skills in analytical testing for small molecules
  • Experience with HPLC/UPLC, GC, GC-with headspace, Karl Fischer, FT-IR, and other physical testing including pH, HIAC, viscosity
  • Comfort in a fast-paced environment - able to rapidly flex activities and priorities
  • Goal-oriented with excellent communication (written and oral) and organizational skills
  • Ability to work effectively in teams
  • Experience with Empower software and electronic notebook (ELN)
  • Experience with analysis and/or analytical development for sterile solutions is preferred

Benefits

Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more.

Pay

N/A

Schedule

N/A

Similar jobs