Melville, NY, 11747, USA
95 days ago
Sr. Manager, Fractionation
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 Senior Manager, Manufacturing is responsible for the manufacturing of human plasma into protein intermediates. **Main Responsibilities:** + Provide leadership and direction to the Managers, Supervisors, and technicians in the Manufacturing Areas. + Develop SOP’s and specifications as required. + Coordinate the process of manufacturing and technology transfer. + Ensure compliance with all cGMP requirements, including batch record review. + Ensure that proper training of all personnel is accomplished effectively and consistently. + 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. + 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. + Function as liaison between Kedrion Biopharma and outside organizations when called upon; Perform other management tasks as requested. + Approve and if necessary, initiate all non-conformance related to the department. + Work effectively with all internal and external customers. **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 **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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