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Job Summary
This position is primarily responsible for the laboratory testing of in-process, release, and stability samples for commercial drug products.
Responsibilities
- Perform accurate and timely analysis of in-process, release, and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines, and safety requirements.
- Testing methods include basic lab equipment and procedures such as pH, Assay by HPLC, and Dissolution.
- Document all laboratory testing and maintain accurate and legible notebooks and records.
- Peer review of data, reports, and notebooks.
Education/Qualifications
- BS Degree in Chemistry or related field.
- Alternatively, an AS Degree in Chemistry or related field with a minimum of 2 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment.
- Or, a BS Degree in a non-science field with a minimum of 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment.
- Knowledge of cGMP, USP/NF, and FDA guidelines and regulations.
- Experience with analytical methods and lab instrumentation such as HPLC, GC, dissolution, and wet chemistry.
- Excellent oral and written communication skills.
- Strong organization and time management skills.
- Ability to work as part of a cross-functional team.
- Working knowledge of Microsoft Word and Excel.
- Experience with Laboratory Information Management System (LIMS) and Chromatography Data System (CDS).
- Work mainly performed in a lab environment.
- Travel less than 5%.
Additional Information
- Seniority level: Entry level.
- Employment type: Full-time.
- Job function: Research, Analyst, and Information Technology.
- Industry: Pharmaceutical Manufacturing.