Responsible for the manufacturing of human plasma into protein intermediaries.
This position is an overnight position working 6pm - 6am alternating days including weekends.
Main Responsibilities
Provide leadership, direction and mentoring to Technicians/Operators/Associates in their respective work environments;Schedules workload for shift and assures a smooth and timely transition between shifts;
Initiates Incident Notifications and conducts and participates in Failure Mode Analysis as necessary;
Ensure all production materials and PPE are present as required;
Ensures all employees are trained effectively and consistently and comply with cGMP’s and SOPs;
Develop SOP’s and specifications as required;
Provide leadership to ensure a safe work environment; Participate in company-wide safety teams, utilizing safety metrics and goals for improvement; Conducts and participates in accident investigations as necessary;
Ensure compliance with all cGMP requirements, including batch record review;
Ensure compliance with all regulations impact the manufacturing operations
Responsible for managing the performance management process of the direct reports including periodic written reviews, coaching, and disciplinary action if required. Manages and resolves conflicts
Participates with outside associations and/or regulatory groups within established guidelines.
Satisfactorily handles conflict situations
Participate in hiring as required to maintain appropriate staffing levels in the department.
Ensures the work area is maintained in a clean an orderly manner in accordance with cGMP and internal requirements;
Must keep the work area in EH&S / GMP regulatory audit ready conditions at all times;
Additional duties as assigned.
Background and Experience:
Bachelor’s degree in science, Engineering, or related field preferred.Five (5) years’ experience in a manufacturing environment with a minimum of three (3) years in a supervisory role.Extensive knowledge of Microsoft Office Suite, Microsoft Project, and Database management.Extensive knowledge of global cGMPs, regulations and validation requirements.Knowledge, Skills, and Abilities
Excellent written and verbal communication skills and ability to communicate effectively at all levels of the organization.Ability to influence, lead teams, and promote a team environment. Demonstrate effective leadership and motivational skills. Focus on delivering excellent customer service.Problem solving skills, results oriented.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.