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 & Strategy
- Provide 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 & Testing
- Oversee development, validation, and transfer of analytical methods for peptide and pharmaceutical compounds.
- Ensure robust testing capabilities including:
- HPLC / UPLC
- LC-MS / LC-MS/MS
- Mass spectrometry
- Peptide purity and identity testing
- Impurity profiling
- Stability studies
- Sterility & endotoxin testing
- Support characterization of APIs, intermediates, and formulations.
- Lead troubleshooting of complex analytical challenges.
Regulatory & Compliance Oversight
- Ensure laboratory operations align with regulatory expectations including:
- 21 CFR Parts 11, 210, and 211
- FDA guidance
- ICH guidelines
- USP standards
- OSHA
- Establish laboratory SOPs, validation protocols, and documentation systems.
- Ensure data integrity, traceability, and audit readiness.
- Support regulatory filings and documentation as needed.
Laboratory Operations
- Manage 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 Collaboration
- Collaborate with clients to support product development programs.
- Serve as a key scientific advisor to leadership on analytical strategy and laboratory capabilities.
Quality & Data Integrity
- Ensure 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 Qualifications
- PhD or MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related scientific field
- 10+ years of experience in pharmaceutical, biotechnology, or peptide analytical environments
- 5+ years in laboratory leadership or management
- Expertise in analytical chemistry techniques used in peptide and pharmaceutical characterization
- Strong experience with HPLC, LC-MS, mass spectrometry, and impurity analysis
- Experience with method development and validation
- Strong knowledge of cGMP, cGLP, ICH, and FDA regulatory expectations
- Proven ability to lead scientific teams and manage laboratory operations
Preferred Qualifications
- Experience working with peptide therapeutics, peptide APIs, or pharmaceuticals
- Experience supporting drug development programs
- Familiarity with FDA-regulated QC environments
- Experience establishing or scaling laboratory operations
- Knowledge of stability studies and degradation analysis
Key Competencies
- Scientific leadership
- Strong communication skills with clients, leadership, and regulatory inspectors
- Analytical problem solving
- Regulatory and quality mindset
- Strategic thinking
- Team development and mentoring
- Cross-functional collaboration
- Operational execution
Equal Employment Opportunity
NxtGen 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 salary
- Health, dental, and vision insurance
- 401(k) with company match
- Paid time off and holidays
- Employee Purchase Program