Laboratory Manager

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Plan, direct and coordinate the day-to-day operational activities of the microbiology and analytical labs.
• Coordinate testing with outside laboratories.
• Work with Finance and Business Development for costing laboratory work.
• Develop and manage stability studies as needed.
• Provide data and analysis for Annual Product Reviews.
• Ensure compliance with applicable quality and regulatory requirements (qualified/trained staff, validated equipment, proper documentation practices, etc.).
• Ensure test methods and production processes meet specified protocol or SOP requirements, are scientifically sound and are performed error-free.
• Oversee testing of utilities, raw materials, bulk products, and finished goods.
• Participate in audits by customers or regulatory agencies.
• Address observations or recommendations as well as implement corrective/preventive actions as needed.
• Notify Quality Management of out of specification test results and assist in the interpretation of what the results mean and how to proceed.
• Perform a failure investigation identifying root cause and take corrective/preventive action in the event of a failure.
• Meet customer expectations for timeliness of lab studies and product shipments.
• Analyze and resolve internal and/or external delays as well as identify trends, recommend improvements and implement improvement activities to achieve annual on-time objectives.
• Provide review and approval of product release documentation from the lab and support review and approval as needed for Certificates of Analysis and Certificates of Compliance for customers.
• Provide exceptional customer service to internal and external customers.
• Regular onsite attendance.
• Adhere to company safety requirements.
• Other duties as assigned.

MINIMUM REQUIREMENTS:

• Bachelor's degree in Chemistry, Microbiology, or a related field.
• 5-10 years lab experience.
• Detailed knowledge of biohazard and USP requirements.

• Minimum 3 years' experience in an FDA regulated environment.

• Experience with ISO, GMP and GLP standards required.
• Experience with laboratory practices including pH testing and titrations.
• Knowledge of the scientific method, chemical products, test procedures, and composition of raw materials including detailed knowledge of chemical management and hazards.
• Knowledge of chemical terminology and units of measure.
• Ability to initiate, perform, and complete reports in a timely manner.
• Ability to work independently with little direction in a fast-paced environment.
• Good interpersonal skills.
• Ability to schedule projects and meet tight deadlines.
• Proficient in Microsoft Office.

LIMITATIONS AND DISCLAIMER

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position.

All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.

Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Continued employment remains on an "at-will" basis.

Silgan is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, or the presence of a disability, which would not prevent the performance of essential job duties with, or without reasonable accommodation of any other protective status.

Silgan is a drug-free workplace.