Manufacturing Shift Leader - Overnights

Kedrion Biopharma • Melville, NY • 1h ago

Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for us in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.

Job Summary

Bring your leadership to the heart of life-saving manufacturing.

At Kedrion Biopharma, every step of our manufacturing process contributes to therapies that improve and save lives for people with rare and serious conditions. As a Manufacturing Supervisor , you'll lead a dedicated team of manufacturing associates, ensuring that each operation is performed safely, efficiently, and to the highest quality standards. This is more than just production - it's about precision, compliance, and the knowledge that your work impacts patients worldwide.

You'll oversee the daily operations for the fractionation and purification of plasma intermediates, ensuring a "Right First Time" execution of tasks while adhering to cGMP and all regulatory requirements. You will also guide critical projects to improve processes, develop documentation, implement Corrective and Preventive Actions (CAPAs), and qualify equipment. Your leadership will inspire operational excellence and build a culture of safety, quality, and continuous improvement.

What you'll do

Lead and supervise daily manufacturing operations to meet safety, quality, production, and financial goals.

Plan, assign, and monitor daily tasks to ensure timely completion in compliance with cGMP and regulatory standards.

Provide on-the-floor leadership presence (minimum 85% of time) to guide operations, solve problems, and support staff.

Manage the timely and accurate execution and review of batch documentation, logbooks, and SAP orders.

Develop and update SOPs and Master Batch Records; train staff on new or revised procedures.

Implement and track CAPAs and change controls, ensuring timely completion and effective corrective measures.

Support manufacturing activities such as buffer preparation, equipment assembly, and parts washing operations.

Supervise equipment and facility maintenance, including cleaning schedules and repair work orders.

Troubleshoot operational issues and drive process improvement initiatives to increase efficiency and quality.

Track performance metrics and ensure department goals and KPIs are consistently achieved.

Foster cross-functional collaboration with Quality Assurance, Facilities, Validation, and QC teams.

Coach, mentor, and develop team members to ensure a motivated, knowledgeable, and compliant workforce.

Maintain a safe, clean, and well-organized production environment that complies with all EHS standards.

Prepare and deliver daily shift reports on safety, schedule adherence, and attendance.

Qualifications and need-to-know

Bachelor's degree in a scientific or engineering discipline and at least 5 years' cGMP manufacturing experience; or high school diploma with 8+ years' relevant experience.

Minimum of 2 years of leadership or supervisory experience.

Experience in fractionation, purification, or manufacturing operations for biopharmaceuticals preferred.

Strong leadership skills with the ability to coach, mentor, and motivate teams.

Proficiency in Microsoft Office, SAP, and production equipment software.

Excellent written and verbal communication skills.

Strong problem-solving skills and the ability to work under pressure in a fast-paced, multi-tasking environment.

Ability to work weekends or supplemental hours to support a 24/7 schedule.

Overnight Role: 6pm-6am

Pay Range: 85,000.00K-105,000.00K

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Please note that salary ranges are calculated based off levels of: relevant experience, education, and certifications.

Kedrion Biopharma Inc. offers numerous benefits to our 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!

If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com .

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.

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