Supervisor, Quality Control Stability

About the role

Primarily responsible for overseeing routine analytical chemistry assays of stability samples, with occasional testing of raw materials, in-process samples, finished APIs, and/or special projects. This role will oversee the day-to-day functions of the Quality Control Stability department and manage a team of Quality Control Chemists focused on stability testing. This position may require work outside of normal business hours as needed.

Responsibilities

• Manage the Quality Control Stability Team
• Performance of analytical testing for various stability samples and incoming, in-process, and final products
• Ensure analytical chemistry functions are completed in accordance with Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
• Supervise a team of scientists including motivation, education, efficiency, performance management, and productivity
• Ensure laboratory operations are conducted in a safe manner; remain familiar with the contents of the Chemical Hygiene Plan and follow safety rules fully
• Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs
• Organize workloads and coordinate activities to carry out multiple projects concurrently in accordance with established objectives, timelines, and deadlines
• Conduct investigations of Out-of-Specification (OOS), Deviations, Change Control Management, and Corrective and Preventive Actions (CAPAs)
• Supervise and perform pharmaceutical analysis to support drug product manufacturing

Requirements

• Bachelor’s degree in Chemistry, Analytical Chemistry, or related field
• Minimum 5 years’ experience in a GMP or FLP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation
• Minimum 2 years supervisory experience
• Strong oral and written communication skills, including effective listening
• Demonstrated ability to effectively utilize team resources
• Expert in cGMP, USP, EP, and FDA regulations
• Technical competence including understanding of theory and interpretation of all lab techniques
• Proficient use of computer software, including Microsoft Office Suite (Excel, Word) and other required software
• Strong organizational skills with the ability to multi-task
• Proficient in HPLC and GC method development and method validation with extensive experience with multiple other analytical techniques and equipment
• Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485, and ICH Stability guidelines

Physical Requirements

• Regularly required to stand, walk, sit, use hands to finger, handle, or feel, and talk or hear
• Frequently required to reach with hands and arms
• Occasionally required to climb or balance, stoop, kneel, crouch, or crawl
• Must occasionally lift and/or move up to 50 pounds
• Specific vision abilities required include close vision and ability to adjust focus

Work Environment

• Potential exposure to fumes or airborne particles and toxic or caustic chemicals (proper Personal Protective Equipment required)
• Occasionally exposed to wet and/or humid conditions, moving mechanical parts, high or precarious places, outside weather conditions, and risk of electrical shock
• Moderate noise level in the work environment
• Responsible for generating hazardous waste for treatment, storage, and disposal; must be familiar with applicable training requirements under the Resources, Conservation, and Recovery Act
• Must understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity, and proper disposal of hazardous materials

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation, and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401k program
• Learning platform

Pay

Pay range: $87,000 - $108,576. Education, experience, location, and tenure may be considered along with internal equity when job offers are extended.