Lab Services Manager

JOB SUMMARY/PURPOSE:

The Manager, Lab Services will oversee and drive method development, Validation, optimization, and routine operation of both quality control and analytical laboratory services within a cGLP laboratory in a biotechnology company. This role is critical to supporting and expanding cGLP laboratory capabilities for manufactured products by providing scientific leadership and managing the execution of analytical testing, method development, qualification, validation, and troubleshooting. This role will require a strong background in analytical chemistry, biopharmaceutical development, and laboratory operations, coupled with excellent leadership and management skills.

PRINCIPAL RESPONSIBILITIES:

1. Leadership & Strategy:

· Lead, mentor, and manage a team of scientists and/or laboratory technicians to ensure optimal performance of the analytical development, validation and routine testing and other laboratory functions.

· Develop/implement strategies to support R&D, method validation and clinical/commercial manufacturing efforts.

· Develop processes and manage Quality Control cGLP procedures for clinical cGMP release testing, validation of methods, stability programs, and collaborate on investigations.

· Work cross-functionally with QA and manufacturing to ensure seamless coordination and support for projects.

· Ensure laboratory activities align with project goals and timelines, and highest standards quality and compliance.

· Keep abreast of scientific methodology and maintain techniques/equipment/approaches to meet project goals.

· Laboratory methods and equipment must adhere to cGLP/cGMP practices and be inspection ready as appropriate.

· Maintain data integrity in keeping with 21 CFR 11.

2. Analytical Development & Validation:

· Lead the development, qualification, and validation of analytical methods for various stages of the product life cycle, from process and method establishment to commercialization.

· Oversee the execution of validation protocols and stability studies working collaboratively with Quality.

· Implement sound scientific approaches to analytical testing and characterization of biopharmaceutical products.

3. Lab Operations & Compliance:

· Oversee laboratory safety, training, and quality assurance processes.

· Manage lab budgets/resource allocation, ensuring the team has the necessary tools/materials to meet objectives.

4. Data Management & Reporting:

· Provide oversight for data collection, analysis, and reporting, ensuring accurate documentation of all test results.

· Prepare and present technical data and findings in reports, presentations, and publications for internal stakeholders, regulatory bodies, and external partners.

QUALIFICATIONS:

Minimum Education Requirements:

• Ph.D. or M.S. in Analytical Chemistry, Biochemistry, Biotechnology, or a related field, with at least 5-10 years of experience in analytical development or laboratory services within the biopharmaceutical or biotechnology industry.
• At least 5 years in a leadership or managerial role, with experience leading cross-functional teams.

Minimum Skills/Experience Requirements:

• Proven experience in method development, validation, and troubleshooting for biologics, including knowledge of analytical techniques such as ELISA, HPLC/UPLC, electrophoresis (e.g. SDS-PAGE), flow cytometry, spectrophotometry and spectroscopy techniques.
• Familiarity with regulatory standards (e.g., FDA, EMA, PMDA, Health Canada) and industry guidelines related to analytical testing and biopharmaceutical product development.

Preferred Qualifications:

• Strong leadership skills with a track record of building and managing high-performing teams.
• In-depth knowledge of laboratory operations, including resource management, budget oversight, and lab safety protocols.
• Excellent communication skills with the ability to present complex scientific data to both technical and non-technical stakeholders.
• Strong project management and organizational skills, with the ability to handle multiple projects simultaneously.
• Expertise in regulatory compliance and GLP/cGMP standards.
• Ability to think critically and solve complex problems related to analytical development and lab services.
• Capable of being client facing and interact with regulatory as needed.

Equipment:

Various laboratory equipment including but not limited to autoclaves, incubators, shakers, UPLC, spectrophotometer, and microscopes.

Working Environment:

The work environment characteristics described here are representative of those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The work is performed primarily in a laboratory room type setting. The primary work attire would include wearing medical scrubs and personal protective equipment. The noise level in the work environment is minimal to moderate. The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar or related to a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

Communication Requirements:

Must be able to read, write and speak English.

Physical Requirements:

The physical demands for this position include standing, bending, reaching, sitting, walking, talking, seeing and/or hearing, lifting and/or moving up to 40 pounds, and are representative of activities that an employee must be able to perform in order to successfully accomplish the essential functions of this job. Other duties might include occasional travel and driving an automobile.

Positioins Supervised:

Lab Techs

OTHER:

This job description in no way states or implies that these are the only functions/duties to be performed by the employee in this position. Employee will be required to follow other job-related instructions and to perform any other job-related duties requested by any personnel authorized to give instructions or assignments. To perform this job successfully, the employee will possess the skills, attributes and abilities to perform each duty proficiently. The requirements in the document are the minimum levels of knowledge, skills and abilities required for this position.

Job Type: Full-time

Pay: $90,000.00 - $110,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $90,000 - $110,000