Supervisor, Chemistry and Stability

Fresenius Kabi USA; Wilson (NC); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

401K with company contribution

Wellness program

Job summary

A leading pharma company located in Wilson, NC is seeking a Chemistry and Stability Supervisor. This role includes managing the daily activities of the Chemistry and Stability Departments, ensuring compliance with quality and regulatory standards, and providing consultations related to product stability. Candidates should have a B.S. in Chemistry or a related field and 5-10 years of experience in the pharmaceutical industry. Excellent communication skills, problem-solving abilities, and experience in regulatory requirements are essential for success in this position.

Qualifications

• Five – Ten years of progressive pharmaceutical lab experience.
• Equivalent combined education and experience in pharmaceutical manufacturing accepted.
• Knowledge of department processes and procedures.
• Knowledge of regulatory requirements and quality systems (GxP) is required.

Responsibilities

• Coordinate training and development of department personnel.
• Aid in assignment of personnel goals and perform reviews.
• Maintain integrity of materials, products, components and data.
• Facilitate investigations for non-conforming materials.
• Provide technical guidance on processes and products.

Skills

Verbal communication

Written communication

Statistical analysis

Problem-solving

Leadership in a team

Flexibility and adaptability

Education

B.S. in Chemistry or related Science

Job description

Overview

The Chemistry and Stability Supervisor will be responsible for the supervision of daily activities in the Chemistry and Stability Departments. The supervisor will assure that activities associated with the testing, release, and results reporting of materials, products and components meet established and expected quality, regulatory and customer requirements. This position oversees the activities of Stability Coordination staff and directly interfaces with other QC Laboratory Supervisors responsible for generating data for stability studies. The role supports virtually all aspects of the business related to the stability program, furnishing stability information, providing consultation on product behavior, and managing special projects to achieve company initiatives. The supervisor will regularly interact with on-site departments and corporate teams such as Operations, Packaging, Quality Assurance, Stability, Validation and Regulatory Affairs.

Responsibilities

• Coordinate the training and development of department personnel.
• Aid in the assignment of personnel goals and objectives. Perform personnel reviews and administer disciplinary actions as required.
• Promote a positive work environment for personnel morale and achievement of goals and objectives. Address personnel issues with assistance from department management and Human Resources.
• Prioritize and track progress of daily activities in the functional area for timely release of materials, products, components and/or information.
• Assure that the integrity of materials, products, components and data is maintained.
• Assure staff conformance with cGMP and FK USA procedures and policies.
• Facilitate department investigations for non-conforming materials, products and/or components.
• Support investigations and corrective/preventive actions for the Company.
• Provide technical guidance on existing and improvements to processes, products, procedures and methods.
• Assist with development and maintenance of department budget.
• Compile information required for Management Reviews and Audit Responses.
• Represent department at meetings.
• Review Stability Testing Protocols for accuracy and compliance.
• Review Stability sections of regulatory submissions prior to filing with the agency.
• Assess impact of Material Change Requests (MCR) to current stability commitments.
• Consult with Regulatory Affairs on interpretation and execution of stability commitments.
• Track acquisition of lots into stability program to ensure all required batches are requested and acquired for regulatory requirements.
• Review stability protocols for accuracy.
• Manage approving, expiry calculation, stability summary, and archiving processes.
• Report department metrics for Quality Management purposes as required.
• Assume area ownership of stability chambers and be responsible for investigating excursions, initiating critical work to be performed, and assessing impact to product stored within.
• Review and manage the regulatory annual reports.
• Provide laboratory supervision support to assign testing, review documentation, and track completion of assignments.
• Develop staff to achieve both departmental and personnel goals.
• Identify and solve personnel issues.
• Support investigations (OOS, OOT, Deviations, Complaints, etc.) as required.
• All employees are responsible for ensuring compliance with company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management Systems, as per roles and responsibilities.

Requirements

• B.S. in Chemistry or related Science
• Five – Ten years of progressive pharmaceutical lab experience
• Equivalent combined of education and experience in pharmaceutical manufacturing, related industrial or clinical experience accepted.
• Excellent verbal and written communication skills are essential.
• Knowledge of department processes and procedures, and a clear understanding of regulatory requirements.
• Demonstrated knowledge of statistical analysis as it pertains to product stability and determination of shelf-life is a plus.
• A demonstrated ability to lead in a team and effect solutions to accommodate competing goals.
• Flexibility, adaptability, and strong desire to work in a dynamic environment.
• Must possess skills to analyze analytical results and solve problems as a backup to Stability Manager.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.