Senior Analytical Professional

2 weeks ago


Bloomington, Indiana, United States Germer International - Pharmaceutical Recruiting Full time
Senior Analytical Professional

Germer International - Pharmaceutical Recruiting is seeking a seasoned analytical professional to support the daily operations of our client's laboratory. As a key member of the team, you will be responsible for developing strategies to ensure effective achievement of objectives.

Our client is working on exciting new projects with cutting-edge technology, offering a highly technical environment where there is always room to grow. If you are looking to join a dynamic team and take on new challenges, this role might be the perfect fit for you.

Key Responsibilities:
  • Ensure timely completion of testing and communicate any material issues or delays to the management team.
  • Critically review raw data, chromatography, data sheets, and protocols for accuracy and completeness.
  • Provide technical support for the evaluation of development, release, and stability data.
  • Review and approve documentation for IND/ANDA/NDA submissions.
  • Prepare and review responses to FDA deficiency letters.
  • Lead a team of analysts and participate in the selection, development, and evaluation of direct reports.
Requirements:
  • BS Degree in Chemistry or related field.
  • Minimum of 5 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment.
  • Experience with writing and editing technical documentation.
  • Knowledge of GMP, Industry Guidelines (ICH/FDA), and A/NDA submissions.
  • Understanding of USP/NF, USP/PF, and other compendia documents.


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