|Date Posted||June 24, 2021|
|Address||645 Science Drive|
The Scientist, Quality, Principal position at MilliporeSigma is responsible for the development and validation of new analytical methods, analysis of samples in the Quality Control department as well as working with and training new or less experienced QC personnel. The Scientist Quality, Principal will be using understanding of analytical instrumentation (HPLC, LCMSMS, GC, GCMS, UV-Vis, TOC, FT-IR, KF, DSC, TGA, IR, IC, Polarimetry, 1H NMR, and XRPD among other tests) in order to be able to critically develop, validate, evaluate, review, and interpret analytical data for final products, intermediates, raw materials and cleaning validations/verifications. The position recommends and implements testing to solve problems as they might arise in the QC department. This position will be developing analytical methods and transferring those methods for eventual validation. The position is also responsible for maintaining project timing/costs and interacting with internal/external clients to assure project goals are met. Other responsibilities include participation in process improvement initiatives, maintaining a clean and safe working environment, and supporting the department in maintaining the laboratory in an audit/inspection ready state.
- Work on significant and unique issues in which analysis of data requires an in-depth evaluation of intangible variables and may impact future concepts, products, or technologies. Apply theoretical concepts and good scientific rationale to identify root cause analysis and implement corrective and preventive actions.
- Independently leads projects teams and provides guidance to and oversees new or less experienced personnel. Meet with internal and external project groups to keep projects on track.
- Solves problems and make decisions independently while keeping management informed.
- Assumes a leadership role within the department.
- Interprets analytical data (including HPLC, LCMSMS, GC, GCMS, UV-Vis TOC, FT-IR, KF, DSC, TGA, IR, IC, Polarimetry, 1H NMR, and XRPD among other tests).
- Develops testing methods to support cleaning validation/verification program; validate or verify methods as necessary. (Stability, Recoveries, ADE/PDE, MACO, TOC)
- Performs review of analytical data for accuracy and quality.
- Trains new or less experienced personnel in SOP content, analytical techniques, and instrument use.
- Executes method transfers/validations into QC and write summary protocols/reports.
- Performs instrument qualifications (DQ, IQ, OQ, PQ), calibration, preventive maintenance (OQPV/PM) and routine equipment maintenance/repair.
- Analytically tests cleaning verification samples, in-process control samples, final products, intermediates, and raw materials. Testing will involve the use of HPLC, LCMSMS, GC, GCMS, UV-Vis TOC, FT-IR, KF, DSC, TGA, IR, IC, Polarimetry, 1H NMR, and XRPD among other tests.
- Conducts, oversees, and reviews OOS investigations.
- Performs requalification of reference standards and maintain reference standard inventory/documentation.
- Writes and revises SOPs including cleaning verification, raw material, intermediate, and final product specifications.
- Technical writing and documentation using the principles of ALCOA+.
- Demonstrates proper laboratory techniques.
- Works in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, 211 and 820 as applicable
- Works in a safe manner and maintain the cleanliness of the work environment.
- Works in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.
WHO YOU ARE:
- M.S. in Chemistry, Biology, Biochemistry or a related life science
- 5+ years in a GLP or current Good Manufacturing Practice (cGMP) analytical laboratory environment or equivalent industry experience.
- 3+ years of leadership experience in analytical testing labs with hazardous/toxic chemicals.
- Ph.D. in Chemistry
- Proficient in HPLC, LCMSMS, GC, GCMS analysis
- 10+ years in cGMP analytical laboratory environment in pharmaceutical quality control department
- Knowledge and understanding of organic analytical chemistry.
- Proficient in HPLC, LCMSMS, GC, GCMS, TOC analysis
- Knowledge of cGMP for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7 cGMP for APIs.
- Excellent organizational, written, and verbal communication and interpersonal skills.