Supervisor, Chemistry and Stability

Fresenius Kabi USA; North Carolina; On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Health benefits (medical, dental, vis*

Paid vacation

Wellness program

Job summary

Fresenius Kabi USA is seeking a Chemistry and Stability Supervisor to oversee daily activities in the Chemistry and Stability Departments. You will ensure testing, release, and reporting meet quality, regulatory and customer requirements, while guiding Stability Coordination staff and interfacing with Operations, QA, and Regulatory Affairs.

The role includes supervising staff, reviewing stability protocols, and supporting investigations and CAPAs to uphold product integrity.

Qualifications

• Bachelor's degree in Chemistry or related science required.
• Five to ten years of progressive pharmaceutical lab experience.
• Strong verbal and written communication skills.
• Knowledge of regulatory requirements and cGMP.

Responsibilities

• Coordinate training and development of department personnel.
• Monitor daily activities to ensure timely release of materials and data.
• Provide technical guidance on processes, products and methods.
• Lead investigations for non-conforming materials and CAPAs.
• Support regulatory submissions and stability program maintenance.
• Manage department budget and prepare management reviews.

Skills

Leadership

Communication

Analytical thinking

Education

Bachelor's degree in Chemistry

Job description

Job Summary The Chemistry and Stability Supervisor will be responsible for the supervision of daily activities in the Chemistry and Stability Departments. The Chemistry and Stability 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 is also responsible for overseeing the activities of Stability Coordination staff. The position directly interfaces with other QC Laboratory Supervisors responsible for generating data to be reported for stability studies. Additionally, the position is an interdepartmental liaison which supports virtually all aspects of the business, as it relates to the compliance of the stability program, the furnishing of stability information, providing consultation on product behavior, and managing special projects to achieve company initiatives. The Chemistry and Stability Supervisor will regularly interact with departments on site and at a corporate level such as Operations, Packaging, Quality Assurance, Stability, Validation and Regulatory Affairs.

Salary Range: $73,614 - $103,528 Position is eligible to participate in a bonus plan with a target of 6% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

• Coordinate the training and development of department personnel.
• Aid in the assignment of personnel Goals & Objectives.
• Perform personnel reviews and administer disciplinary actions as required.
• Promote a positive work environment for personnel morale and achievement of goals & objectives.
• Address personnel issues with assistance from department Management and Human Resources.
• Prioritize and track progress of daily activities in 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/preventative 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.
• Reviews Stability Testing Protocols for accuracy and compliance.
• Reviews Stability sections of regulatory submissions prior to filing with the agency.
• Assesses impact of Material Change Requests (MCR) to current stability commitments.
• Consults with Regulatory Affairs on interpretation and execution of stability commitments.
• Tracks acquisition of lots into stability program to ensure all required batches are requested and acquired for regulatory requirements.
• Reviews stability protocols for accuracy.
• Manages approving, expiry calculation, stability summary, and archiving processes.
• Reports department metrics for Quality Management purposes as required
• Assumes area ownership of stability chambers and is responsible for investigating excursions, initiating critical work to be performed, and assessing impact to product stored within.
• Review and manage the regulatory annual reports Provides laboratory supervision support to assign testing, review documentation, and track completion of assignments.
• Develops staff to achieve both departmental and personnel goals.
• Identifies and solves personnel issues.
• Support investigations (OOS, OOT, Deviations, Complaints, etc.) as required.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your 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 manufac turing, 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 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.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition.

Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients.

With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients - and to find answers to the challenges they face. We call this purpose caring for life.

Our U.S. headquarters is in Lake Zurich, Illinois and the company's global headquarters is in Bad Homburg, Germany.

Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr