Job Description

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

PRIMARY PURPOSE:

The Analytical Laboratory Supervisor is responsible for overseeing daily operations, staff, and projects to ensure compliance and efficiency. Key responsibilities include supervising and training lab personnel, ensuring quality control and regulatory adherence, managing workflow and scheduling, and handling administrative duties and budgets. The role requires a strong background in chemistry, often with experience in analytical techniques and specific pharmaceutical industry practices.

MAJOR DUTIES AND RESPONSIBILITIES:

• Routinely reviews and releases environmental testing, raw materials, in-process/bulk/intermediate, finished product, stability, and method validation/transfers.
• Creates COAs for finished goods batches.
• Oversee daily operation of QC Laboratory.
• Occasionally performs testing, and accurately records raw data, analyzes data, and calculates and interprets the results.
• Order supplies ensuring that the laboratory is adequately supplied.
• Manage the reference standards/materials program.
• Plan daily technical activities in order to meet established timelines. Provide input to establish project timelines.
• Qualify, calibrate, and maintain laboratory equipment, including review of activities and data.
• Support general laboratory maintenance.
• Support site and Technical Operations validation and assessment activities such as reviewing and approving protocols and reports.
• Write, review, and revise SOPs as required.
• Ensure testing is performed accurately and in compliance with GLP, GMP, USP, SOP and other approved test methods
• Proactively investigate and identify areas of improvement.
• Investigate, support, validate and implement new laboratory procedures and techniques.
• Provide monthly lab metrics to management.
• Maintain a level of technical knowledge and understanding of Analytical testing consistent with current scientific literature.
• Perform scientific literature searches and evaluations as needed.
• Design, within a defined scope, experiments or a series of experiments to address specific project goals.
• Train laboratory personnel in lab techniques as required.
• Responsible for Cleaning Validation and Method Validation activities.
• Follow cGMP, cGLP and OSHA guidelines with regards to work practices and safety.
• Other duties which may be assigned sometimes by site management.

JOB REQUIREMENTS:

• A minimum of a BS in Chemistry or related field
• Minimum of 5 years’ experience preferably in the pharmaceutical industry
• Capable of preparing cGMP and other laboratory documents
• Excellent knowledge of computer systems and software
• Good knowledge of cGMP and FDA regulations
• Excellent interpersonal, organizational, communication skills

WORK ENVIRONMENT:

• GMP Manufacturing and Laboratory Environment
• May be exposed to laboratory chemicals and solvents

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