Sr Production Manager Fractionation

3 months ago

Melville, United States Kedrion Biopharma Full time

Scope: 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 trouble shooting

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 when called 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.

Job Requirements:

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.

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