Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.The Manufacturing Supervisor is responsible for leading a team of manufacturing associates in processing for biopharmaceutical products. This role involves planning, assigning, and monitoring daily tasks to ensure timely execution with a "Right First Time" approach, while strictly adhering to safety protocols, Current Good Manufacturing Practices (cGMP), and quality regulations. In addition to managing daily operations, the supervisor will lead projects focused on creating and updating Standard Operating Procedures (SOPs) and Master Batch Records (MBRs). They will also implement Corrective and Preventive Actions (CAPAs) and assist in specifying, commissioning, and qualifying equipment and processes.This leader will utilize their knowledge and experience in the fractionation and purification of blood intermediates to train team members, troubleshoot issues, and continuously improve daily operations. They will support manufacturing activities, including buffer preparation, equipment assembly and parts washing operations. The Supervisor will take ownership of the production processes, manufacturing environment, and facility, ensuring that operations are conducted accurately, safely, and in compliance with regulations. After task execution, the Supervisor will review the completed production batch records and production orders to confirm that all actions have been accurately completed.Main Responsibilities
Ensure a safe work environment complying with all labor laws and state and federal regulations.
Represent manufacturing in site safety teams, utilizing safety metrics and goals for improvement.
Supervise daily manufacturing operations to meet safety, quality, production, and financial targets.
Plan, schedule, and support daily production tasks to ensure adherence to the schedule while executing operations in compliance with current Good Manufacturing Practices (cGMP).
Facilitate additional manufacturing activities and provide process support in collaboration with other manufacturing groups, including MS&D, QA, Facilities, Validation, and QC.
Ensure the timely execution and review of batch documentation and logbooks, as well as the initiation of deviations and the execution and completion of SAP orders.
Implement timely corrections to batch documentation and logbooks as necessary.
Supervise, coach, mentor, and train team members to maintain a knowledgeable, qualified, and motivated workforce, ensuring that staff uphold high standards of compliance with procedures and quality expectations.
Oversee the maintenance and operation of equipment and manufacturing facilities by managing cleaning schedules and ensuring the timely submission of work orders for maintenance and repairs.
Author, train, and review manufacturing procedures to ensure clarity and compliance.
Drive process improvement initiatives, troubleshoot operational issues, track and trend metrics, and author, review, and approve manufacturing deviations, Corrective and Preventive Actions (CAPAs), and change controls as needed.
Actively supervise the manufacturing teams ensuring personnel complete training and career development plans.
Enforce manufacturing procedures, policies, and programs to subordinates to eradicate process and product discrepancies.
Ensure department goals and KPIs are met in their respective shifts.
Oversee production documentation performance (adherence?) and direct implementation of new or modified procedures.
Create and prepare daily shift reports, on safety, schedule adherence and attendance.
Perform miscellaneous duties and projects as assigned or required.
Supervisory:
Supervise direct reports.
Lead by example and in accordance with the company values
Maintain production floor presence and focus (min 85%).
Establish and communicate performance expectations to meet or exceed standards.
Mentor and develop junior staff, providing guidance and support for their success and to meet established goals.
Supervise work assignments to include support and rearrange the workload of direct reports as needed.
Provide constructive and timely feedback as it relates to performance, including motivating and evaluating employees based on established performance standards.
Maintain an open, positive, and supportive work environment.
Receive, investigate, and respond to employee grievances using recommendations and guidance from the department manager and human resources when needed.
Background and Experience:
Bachelor’s degree in a related scientific or engineering discipline and 5 years’ experience in related cGMP manufacturing operations; or high school degree and 8 years’ experience, or equivalent.
2+ years prior leadership/supervisory experience.
Demonstrated knowledge of fractionation or manufacturing operations for production of biopharmaceuticals preferred.
Working Conditions:
Weekend work and weekday supplemental hours may be necessary to oversee shift operations in a work 24/7 schedule.
Wearing personal protective equipment (PPE) and controlled area garments will be necessary.
Capable of working in a cold and wet environment.
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained. In lieu of HAZWOPER training, the employee will receive training on the requirements of the New York State hazardous waste management regulations pursuant to 6 NYCRR §373-3.2. All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the personnel training requirements of the NYSDEC.Kedrion Biopharma offers a number of benefits to qualifying employees, including:
Medical, vision and dental insurance
- Life and AD&D insurance - Paid holidays - PTO accrual - and much more! Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security. Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.
