Job Description
Job Description
Job Title
Manager, Lab Services
Job Summary / Purpose
The Manager, Lab Services oversees and advances method development, validation, optimization, and day-to-day operations within a cGLP-compliant analytical and quality control laboratory. This position plays a key role in enhancing lab capabilities to support product development and manufacturing by leading scientific initiatives and managing analytical testing, troubleshooting, and method execution. A strong foundation in analytical chemistry, biopharmaceutical processes, and lab operations is essential, along with demonstrated leadership experience.
Responsibilities
1. Leadership & Strategy
- Lead, mentor, and manage a team of scientists and lab technicians, ensuring strong execution across analytical development, validation, and routine testing.
- Develop and implement lab strategies that align with research, development, and clinical/commercial manufacturing needs.
- Manage cGLP-compliant quality control procedures, including clinical cGMP release testing, method validation, stability programs, and investigative collaboration.
- Work cross-functionally with quality assurance and manufacturing to support project execution.
- Align laboratory operations with project milestones, quality standards, and regulatory compliance.
- Stay informed on advancements in scientific methodologies and maintain up-to-date tools and techniques.
- Ensure lab practices meet cGLP/cGMP standards and are inspection-ready.
- Maintain data integrity per 21 CFR Part 11 guidelines.
2. Analytical Development & Validation
- Direct the development, qualification, and validation of analytical methods across product lifecyclesfrom early development through commercialization.
- Oversee execution of method validation protocols and stability studies in collaboration with quality teams.
- Apply rigorous scientific methodologies for analytical testing and characterization of biopharmaceutical products.
3. Lab Operations & Compliance
- Manage lab safety programs, staff training, and quality assurance initiatives.
- Oversee budgeting and resource allocation to ensure operational efficiency and support for scientific objectives.
4. Data Management & Reporting
- Supervise data collection, analysis, and documentation processes, ensuring accuracy and compliance.
- Prepare and deliver technical findings through reports, presentations, and publications for both internal and external stakeholders, including regulatory agencies.
Qualifications
Minimum Education Requirements
- Ph.D. or M.S. in Analytical Chemistry, Biochemistry, Biotechnology, or related discipline.
- 510 years of experience in analytical development or lab services in the biopharmaceutical or biotechnology sector.
- Minimum of 5 years in a leadership or managerial role with cross-functional team oversight.
Minimum Skills / Experience Requirements
- Demonstrated expertise in method development, validation, and troubleshooting for biologics.
- Proficiency with analytical techniques including ELISA, HPLC/UPLC, electrophoresis (e.g., SDS-PAGE), flow cytometry, spectrophotometry, and spectroscopy.
- Strong understanding of regulatory frameworks (e.g., FDA, EMA, PMDA, Health Canada) relevant to analytical testing and product development.
Preferred Qualifications
- Proven leadership abilities and experience managing high-performing teams.
- Comprehensive knowledge of lab operations, including budgeting, resource planning, and safety compliance.
- Effective communication skills for presenting complex scientific data to diverse audiences.
- Strong organizational and project management capabilities with experience juggling multiple priorities.
- Deep understanding of GLP/cGMP compliance and regulatory expectations.
- Critical thinking and problem-solving expertise in analytical and lab service contexts.
- Comfortable in client-facing roles and engaging with regulatory authorities as required.
Additional Details
Equipment Used
- Standard lab instruments such as autoclaves, incubators, shakers, UPLC systems, spectrophotometers, and microscopes.
Working Environment
- Primarily laboratory-based, with moderate noise levels.
- Requires use of medical scrubs and personal protective equipment.
- Job functions may include tasks not explicitly listed; duties may evolve with operational needs.
- This description does not represent a contractual agreement; responsibilities may be updated by management.
Communication Requirements
- Must be proficient in reading, writing, and speaking English.
Physical Requirements
- Activities include standing, sitting, walking, bending, lifting (up to 40 lbs), and occasional travel or vehicle operation.
Positions Supervised
- Laboratory Technicians