- Job Level:
The Analytical Scientist will be part of a team of drug development professionals responsible for the continued development and regulatory approval of thin film drug products containing a wide range of therapeutic compounds.
- Hands-on laboratory analysis of R&D drug substance and drug product samples.
- Method development, method transfer and validation of analytical methods developed in-house or from client.
- Provide analytical support during pre-formulation, formulation development and manufacture of prototype formulations, clinical trial materials and process scale-up.
- Perform characterization, release and stability testing of raw material and drug product samples for conformance to specifications.
- Prepare and update/review SOPs for the analytical laboratory.
- Observe and maintain compliance with applicable DEA and safety regulations, cGLP/GMP guidelines, and Company policies and procedures.
- Interact in a team atmosphere, providing expertise in general analytical techniques.
- Troubleshooting and repair of minor problems in analytical instruments.
- Responsible for laboratory work area housekeeping.
- Assist with raw data review, analysis, report writing and laboratory investigations (OOT/OOS).
- Ensure that responses to regulatory inquiries are conducted in accordance with regulatory guidelines and in consideration of business implications.
BS/MS in Chemistry.
Experience & Skills Required
- Minimum 3 - 5 years of pharmaceutical experience in an R&D analytical laboratory supporting small molecule, protein and peptide development programs.
- Strong analytical skills, proven experience in wet chemistry, HPLC, Dissolution, KF, GC and spectrophotometry.
- Thorough knowledge of cGMPs, compendia requirements, FDA and EMA regulations.
- Experience working with and interpreting regulatory documents such as CFRs, FDA and ICH Guidance documents.
- Excellent written and oral communication skills with an ability to prepare and present concise, technical data reports to non-scientific counterparts.
- Prior experience with FDA/EMA inspections and audits a plus.
- Proficiency in standard office software (MS Word, Excel, PowerPoint).
- Must be detail oriented and organized with excellent documentation practices.