Leader of Laboratory Operations

We are seeking an experienced individual to provide effective leadership for analytical testing, microbiological/sterility testing, and research support functions. This role is responsible for establishing and overseeing contract testing laboratory operations, analytical method development, validation, oversight of investigations, and scientific leadership supporting peptide and pharmaceutical product testing.This position will ensure the laboratory operates at the appropriate scientific and regulatory standards while supporting innovation, efficiency, and data integrity. This leader will provide oversight and support for scientists and analysts, confirm analytical instrumentation and testing workflows, and ensure laboratory activities align with client and regulatory expectations including FDA, USP, and ICH.This role requires a strategic scientific leader with expertise in analytical chemistry, microbiological testing, peptide characterization, pharmaceutical testing methodologies, and laboratory operations.Key Responsibilities:Laboratory Leadership & StrategyProvide strategic leadership for the laboratory personnel.Build, lead, and mentor a team of analytical/microbiological chemists, scientists, and laboratory technicians.Establish laboratory priorities, resource planning, and project timelines aligned with TAT requirements from the clients.Develop laboratory capabilities supporting peptide research, analytical characterization, and formulation development.Foster a culture of scientific rigor, data integrity, and continuous improvement.Analytical Method Development & TestingOversee development, validation, and transfer of analytical methods for peptide and pharmaceutical compounds.Ensure robust testing capabilities including:HPLC / UPLCLC-MS / LC-MS/MSMass spectrometryPeptide purity and identity testingImpurity profilingStability studiesSterility & endotoxin testingSupport characterization of APIs, intermediates, and formulations.Lead troubleshooting of complex analytical challenges.Regulatory & Compliance OversightEnsure laboratory operations align with regulatory expectations including:21 CFR Parts 11, 210, and 211FDA guidanceICH guidelinesUSP standardsOSHAEstablish laboratory SOPs, validation protocols, and documentation systems.Ensure data integrity, traceability, and audit readiness.Support regulatory filings and documentation as needed.Laboratory OperationsManage laboratory infrastructure, equipment, and instrumentation.Oversee calibration, qualification, and maintenance of analytical equipment.Ensure proper laboratory safety protocols and compliance with environmental and occupational safety requirements.Implement appropriate data management solutions.Cross-Functional CollaborationCollaborate with clients to support product development programs.Serve as a key scientific advisor to leadership on analytical strategy and laboratory capabilities.Quality & Data IntegrityEnsure analytical data meets the standards for scientific accuracy and regulatory defensibility.Approve analytical reports, protocols, validation studies, and scientific documentation.Lead investigations for analytical deviations, out-of-specification results, and method issues.Required QualificationsPhD or MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related scientific field10+ years of experience in pharmaceutical, biotechnology, or peptide analytical environments5+ years in laboratory leadership or managementExpertise in analytical chemistry techniques used in peptide and pharmaceutical characterizationStrong experience with HPLC, LC-MS, mass spectrometry, and impurity analysisExperience with method development and validationStrong knowledge of cGMP, cGLP, ICH, and FDA regulatory expectationsProven ability to lead scientific teams and manage laboratory operationsPreferred QualificationsExperience working with peptide therapeutics, peptide APIs, or pharmaceuticalsExperience supporting drug development programsFamiliarity with FDA-regulated QC environmentsExperience establishing or scaling laboratory operationsKnowledge of stability studies and degradation analysisKey CompetenciesScientific leadershipStrong communication skills with clients, leadership, and regulatory inspectorsAnalytical problem solvingRegulatory and quality mindsetStrategic thinkingTeam development and mentoringCross-functional collaborationOperational executionEqual Employment OpportunityNxtGen is a Disabled and Veteran Equal Employment Opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.Benefits Competitive salaryHealth, dental, and vision insurance401(k) with company matchPaid time off and holidaysEmployee Purchase Program