Qc Chemist (Sme) - Biopharmaceutical New Site Start-Up

Job Description
POSITION SUMMARY:
We have an exciting opportunity for an SME in QC Chemistry to help our PSS client set-up a new laboratory. The Principal Scientist, QC Chemistry is responsible for contributing to key functional, tactical, and operational aspects of the QC group at our PSS client site.
The Principal Scientist, QC Chemistry is accountable for GMP compliant laboratory operations according to GMP guidelines. This role is responsible for setting up procedures for performing Chemistry and Chromatography testing for in process, drug substance, drug product and stability testing for the manufacturing of Biologics.
The QC Chemistry team performs TOC, nitrate, and conductivity testing for Utility Monitoring samples. The Principal Scientist, QC Chemistry is responsible for creating or implementing procedures to deliver on-time results for methods including:
compendial, chromatography, spectroscopy, protein concentration, chemical analysis of stability samples, glycan analysis and wet lab chemistry.
This role provides managerial support for troubleshooting of complex investigations and optimizing laboratory systems. The position ensures the laboratory is maintained in a state of GMP compliance, all documentation is in accordance with GMP, and all reported results are accurate. The Principal Scientist, QC Chemistry is the technical subject matter expert (SME), represents the client QC Chemistry team during regulatory and customer audits, and models leadership competencies and aid in the development of QC team members.
The QC Chemistry team is responsible for executing the following analytical methods:
chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance.
POSITION RESPONSIBILITIES:
Ensures GMP compliant laboratory operations according to guidelines
Manages the support of DS and DP Manufacturing Process, testing of stability samples, method transfers of client methods, and change management.
Oversees and manages laboratory exceptions and investigations and assures timely closure of cGMP KPI deliverables within the group.
Authors procedures, documents and reports, as needed, to support QC Chemistry and tech transfer activities.
Prioritizes and focuses on optimized laboratory systems, including the use of IT systems (e.G. Labware)
Identifies and implements needed procedural and/or policy changes in areas where needed
Enforces established policies, processes and procedures and identifies areas where enhancements will improve daily work.
Represents client QC Chemistry in cross-functional collaboration with QC Analytical Development, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve client objectives.
Authors, reviews, and approves data reports, out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls.
Manages complex problem solving, providing mitigation/outcome to management/team. Decisions at this level include those that have potential compliance impact to methods, results, product, and/or Quality systems, decisions with impact to customers, or pertaining to personnel issues that must be handled with consultation and recommendations to management.
Supports management activities related to compliance with policies, appropriate personnel training, providing feedback for personnel development, and effective and timely decision making/corrective actions on the floor.