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

Company Description

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you're looking for a rewarding career, a place to call home, apply with us today!

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.

Qualifications

BASIC MINIMUM QUALIFICATIONS:

• Bachelor's degree with 8+ years of experience in a GMP environment or Master's degree with 6+ years of experience in GMP environment or Ph.D. with 4+ years of experience in GMP environment

• An advanced knowledge of GMP requirements for laboratory operations.

• 5+ years of experience with analytical testing, preferably raw material testing and release

• Proficient in physical and chemical testing methods for biological products, including 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 sub-visible particle analysis, and glycan analysis, and peptide mapping

• Possesses a broad knowledge of quality control operations, systems, and directives

• Previous QC Raw Materials Management experience

• Experience setting up a new laboratory

PREFERRED QUALIFICATIONS:

• Master's degree or Ph.D. in Chemistry, Microbiology, Biological Sciences, Engineering or related science degree with 6+ years of GMP experience or Ph.D. in Chemistry, Microbiology, Biological Sciences with 4+ years of GMP experience

• Previous experience with analytical testing, preferably raw material testing and release in the biopharmaceutical industry

• Experience with Microsoft Office, Smartsheet and laboratory LIMS and ERP systems (e.g., SAP)

Additional Information

Position is Full Time, Monday-Friday, First Shift. Candidates currently living within a commutable distance of Holly Springs, NC are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays

• Eligibility for potential yearly Bonus & Merit-Based Pay Increases

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.