- Reference ID: Med001
- Type: Permanent
We are currently seeking experienced analytical scientist for our drug development team based in a Chicago Suburb. The candidate should have direct experience with analytical method development, validation, and analysis for parenteral dosage forms.
- Lead analytical development of parenteral formulations in a product development environment.
- Act as a Subject Matter Expert for chromatograph techniques such as HPLC, GC, TLC, IC, LC-MS, and GC-MS.
- Lead different wet chemistry testing.
- Responsible for leading all analytical aspects of a project while working with other functional areas to advance projects through the pipeline.
- Lead API and finished product related method development, optimization, validation, and release and stability testing.
- Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
- Responsible for all aspects of Analytical Development and Validation including transfer to Quality Control or other testing laboratory.
- Evaluate thoroughly DMF for different APIs for completion of analytical methods and lead discussions with API manufacturers to evaluate analytical method package.
- Support corporate quality and continuous improvement process.
- Write protocols, methods, standard operation procedures, and submission documents independently. Design experimental studies and write reports with minimal supervision.
- Supervisor CRO work to ensure corporate quality is maintained and activities are performed on timely manner.
- Maintain through knowledge of ICH conditions, USP method development, validation, and verification requirements.
- Accurately records experimental procedures, test results, and observations to meet GMP requirements.
- Maintain experimental records, procedures to meet cGMP requirements.
- Participate in the review process for appropriate department SOPs, study protocols, and reports.
- Participate in the training of incoming laboratory staff.
- Participate as needed in departmental efforts directed toward equipment maintenance, calibration, and qualification.
- Author various sections in Chemistry, Manufacturing and Control (CMC) document for Regulatory submission.
- Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule.
- Provide crucial support to other team members in the conduct of their studies.
- Ph.D. and MS in Chemistry or other related field with 3+ years’ experience.
- Ability in the area of characterization of peptides is desirable.
- Working knowledge of cGMPs, cGLPs
Skills (Reading, Writing, Verbal Communication, Computer, etc.):
- Must be able to work independently and have good time management skills
- Proficient in writing.
- Excellent organizational, communication, teamwork, and interpersonal skills
- Strong leadership and mentoring skills