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Kedrion Biopharma, Inc. Sr. Manager, Fractionation in Melville, New York

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.

Kedrion Biopharma Inc. manufactures human plasma into protein intermediates. The Sr Manufacturing Manager is responsible for providing leadership to the team leaders and technicians in the manufacturing area. The position is responsible to be the technical subject matter expert available to provide hands on training to the teams and assist with trouble shooting issues.

Main Responsibilities:

  • Provide leadership and direction to the shift leaders and technicians in the Manufacturing Areas.

  • Problem solving oriented; good relationship with engineering and maintenance for troubleshooting.

  • Develop SOPs and specifications as required.

  • Coordinate the process of manufacturing and technology transfer.

  • Ensure compliance with all cGMP requirements, including batch record, logbook, and all documentation review.

  • Perform hiring as required to maintain appropriate staffing levels in the department.

  • Maintain fiscal responsibility by ensuring that department spending is within budget levels. Provide monthly analysis of expenditures and prepare annual budget.

  • Provide for efficient scheduling of product throughout.

  • Provide leadership to ensure a safe work environment. Participate in companywide safety teams, utilizing safety metrics and goals for improvement.

  • Perform other management tasks as requested.

  • Ensure that proper training of all personnel is accomplished effectively and consistently.

  • Maintain manual and computerized systems to ensure continuous productivity improvement and deliver an outstanding level of customer service.

  • Ensure compliance with all regulations impacting the manufacturing operations.

  • Act as liaison between Kedrion Biopharma and outside organizations whencalled upon;

  • Perform other management tasks as requested.

Background and Experience:

  • Bachelor’s degree in science, Engineering, or related field required.

  • Fifteen (15) years' experience in a manufacturing environment with a minimum of ten (10) years in a supervisory role

  • Extensive knowledge of global cGMPs, regulations and validation requirements

  • Important experience in plasma derivatives manufacturing and at least 5 years in fractionation department.

Knowledge Skill and Abilities

  • Strong leadership and motivational skills.

  • Focus on delivering excellent customer service.

  • Excellent communication skills both verbal and written.

  • Problem solving skills, results oriented.

  • Knowledge of Microsoft Office required.

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 within the first six months of 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.

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