Senior Analytical Chemistry Laboratory Consultant

VTI Life Sciences•Mundelein, IL

3d•Onsite

About The Position

VTI Life Sciences is seeking an experienced Senior Analytical Chemistry Laboratory Consultant to perform a comprehensive assessment of an in-house Quality Control chemistry laboratory supporting raw material, in-process, and finished product release testing for multiple manufacturing sites. The consultant will evaluate laboratory operations, analytical methods, procedures, documentation, equipment, computerized systems, and quality controls for compliance with applicable current Good Manufacturing Practice (cGMP) requirements, United States Pharmacopeia (USP) requirements, and recognized pharmaceutical laboratory industry practices. The successful candidate should have extensive hands-on and/or laboratory leadership experience in a GMP-regulated pharmaceutical Quality Control laboratory and be capable of independently identifying compliance gaps, evaluating analytical practices from both a regulatory and scientific perspective, and recommending practical corrective and improvement actions. We offer an opportunity to support our teams of industry subject-matter experts and thought leaders while consulting with leading companies in the Life Sciences industry.

Requirements

Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a closely related scientific discipline.
Minimum 10 years of analytical chemistry experience within the pharmaceutical, biotechnology, or similarly regulated industry, preferably including significant experience in a GMP Quality Control laboratory.
Extensive experience with raw material, in-process, and/or finished product testing in a GMP environment.
Strong hands-on knowledge of analytical laboratory techniques, preferably including HPLC/UPLC and GC as well as common compendial chemical and physical testing methods.
Demonstrated experience with analytical method validation, verification, transfer, and troubleshooting.
Strong experience investigating OOS/OOT and atypical analytical results.
FDA 21 CFR Parts 210 and 211, particularly laboratory control requirements under 21 CFR Part 211 Subpart I.
USP General Chapters applicable to analytical laboratory operations and testing.
USP requirements governing compendial methods, method verification, analytical procedure validation, and instrument qualification.
ICH Q2(R2) – Validation of Analytical Procedures.
ICH Q14 – Analytical Procedure Development.
FDA guidance and regulatory expectations regarding investigation of OOS laboratory results.
FDA expectations regarding pharmaceutical laboratory data integrity.
21 CFR Part 11, as applicable to laboratory electronic records and computerized systems.
ALCOA+ data integrity principles.
Good Documentation Practices (GDP).
Analytical method lifecycle, transfer, verification, validation, and change-control principles.
Current industry practices for pharmaceutical Quality Control laboratory operations.
Strong technical knowledge of pharmaceutical analytical chemistry and GMP Quality Control laboratory operations.
Ability to assess analytical practices from both a scientific and regulatory compliance perspective.
Ability to distinguish regulatory requirements from industry best practices and identify situations requiring documented scientific justification.
Strong understanding of analytical method performance and the ability to recognize technically questionable laboratory practices or data.
Strong knowledge of OOS/OOT investigations and the ability to evaluate whether laboratory investigations are scientifically justified and sufficiently thorough.
Strong understanding of laboratory data integrity principles and electronic analytical data.
Excellent observational, interviewing, and auditing skills.
Ability to identify systemic laboratory and quality-system weaknesses rather than focusing solely on individual procedural deficiencies.
Strong technical writing skills and ability to clearly communicate observations, risks, and recommended corrective actions.
Ability to interact effectively with laboratory analysts, laboratory management, Quality personnel, manufacturing representatives, and senior leadership.
Ability to work independently and exercise sound scientific and regulatory judgment.
Practical, risk-based approach to compliance and remediation.

Nice To Haves

Master's degree or Ph.D. in Chemistry, Analytical Chemistry, or Pharmaceutical Sciences is preferred but not required.
Experience assessing or auditing GMP analytical laboratories strongly preferred.
Previous laboratory supervisory, management, technical-lead, or analytical SME experience preferred.
Experience supporting FDA inspections, other regulatory inspections, internal audits, or laboratory remediation activities highly desirable.
Experience with laboratory computerized systems and chromatography data systems such as Waters Empower or equivalent systems is desirable.
Experience with laboratories supporting multiple manufacturing facilities is preferred.
The individual should have substantial hands-on familiarity with raw material, in-process, and finished product release testing and understand how analytical laboratory activities function within an effective pharmaceutical quality system.
The strongest candidate will have significant experience with chromatographic and compendial analytical methods, analytical method validation and transfer, OOS/OOT investigations, laboratory data integrity, and analytical equipment and computerized systems.
Experience participating in FDA or other regulatory inspections, conducting laboratory audits, and remediating significant laboratory compliance deficiencies is highly desirable.
For this assignment, the consultant must be able to go beyond performing a document or SOP review. The individual should be capable of observing actual laboratory practices, interviewing analysts and management, reviewing raw analytical data and representative investigations, assessing analytical methods and laboratory controls, and determining whether the laboratory is operating in a state of control and whether the data it generates are scientifically sound, reliable, and suitable to support material and product release decisions.

Responsibilities

Conduct a comprehensive assessment of analytical laboratory operations against applicable FDA cGMP requirements, USP requirements, internal procedures, and recognized pharmaceutical industry practices.
Evaluate laboratory organization, staffing, training, analyst qualification, supervision, and Quality Unit oversight.
Review laboratory practices associated with raw material, in-process, and finished product release testing, including sample receipt, handling, storage, testing, review, retention, and disposition.
Assess the execution and control of compendial and non-compendial analytical methods.
Evaluate laboratory practices involving analytical techniques and equipment such as HPLC/UPLC, GC, UV-Vis, FTIR, TOC, pH, conductivity, Karl Fischer, titration, dissolution, and other applicable chemical and physical testing.
Assess analytical method validation, verification, transfer, and method suitability practices, including evaluation of accuracy, precision, specificity, linearity, range, robustness, detection/quantitation limits, and other applicable method characteristics.
Review laboratory controls for standards, reference materials, reagents, solutions, columns, and other laboratory supplies, including preparation, qualification, labeling, storage, expiration/retest dating, and traceability.
Evaluate analytical equipment qualification, calibration, preventive maintenance, system suitability, and routine performance controls.
Assess chromatographic data systems and other laboratory computerized systems from a laboratory-user and data-integrity perspective, including user access, audit trails, electronic records, data review, and retention practices.
Review laboratory data integrity and Good Documentation Practices, including raw data, worksheets, laboratory notebooks, calculations, electronic records, metadata, data review, and record retention.
Evaluate procedures and practices for handling OOS, OOT, atypical results, invalid tests, deviations, laboratory errors, retesting, resampling, and investigations.
Assess laboratory investigation practices to determine whether investigations are scientifically sound, adequately documented, identify appropriate root causes, and result in effective CAPA where required.
Evaluate laboratory trending and statistical review practices for analytical results, OOS/OOT events, method performance, and other relevant quality indicators.
Review laboratory controls associated with specifications, Certificates of Analysis, test-result approval, and release decisions.
Assess laboratory facility conditions and workflow, including sample and standard storage, environmental controls where required, segregation of activities, and controls designed to prevent sample mix-ups or contamination.
Review the adequacy of SOPs, specifications, analytical methods, protocols, worksheets, and other controlled laboratory documentation.
Evaluate the interface between the laboratory and the manufacturing sites it supports, including sample submission, specifications, methods, investigations, data communication, change control, and responsibilities for product disposition.
Assess change-control practices associated with analytical methods, specifications, equipment, computerized systems, and laboratory procedures.
Identify compliance gaps, operational weaknesses, and opportunities for improvement and prioritize findings based on potential impact to product quality, data integrity, and regulatory compliance.
Develop practical, risk-based recommendations for remediation and laboratory improvement.
Prepare and/or contribute to an assessment report summarizing observations, compliance gaps, risks, and recommended corrective actions.
Present and discuss assessment findings with laboratory management, Quality, manufacturing-site representatives, and other stakeholders.