Sterility Assurance Senior Manager

The Sterility Assurance Senior Manager is responsible for leading sterility assurance and contamination control efforts for support of new product development. The Sterility Assurance Manager will work cross-functionally to develop processes for the aseptic manufacture of parenteral drugs. This includes the following contamination control programs: clean room and isolator design and qualification, media fill programs, development of disinfection practices, environmental and critical utilities monitoring, gowning programs and the subsequent training of operators on the aseptic technique for the process, including OJT and Media Fill qualification. Author and Review SOP's, OJT's, Job Aids, Batch Records and Regulatory Submissions.

Schedule:

Monday - Friday 8am - 4:30pm

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Work cross functionally to coordinate testing schedules and communications in support of the weekly production activities and ensure QC testing and maintenance activities are completed per requirements.
• Ensure team compliance with all policies, procedures and site/company regulations.
• Work safely with radioactivity and ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.
• Strong organizational and project management with the ability to juggle multiple projects/priorities.
• Strong technical writing skills.
• Assure compliance with department training and qualification.

• Bachelor of Science Degree in Chemistry, or other science related field required.
• 15 or more years of relevant experience required.
• 2 or more years of leadership experience in a cGMP environment.
• Lean Leader/Operational Excellence/5S preferred.
• Laboratory Instrument qualification preferred.
• Method validation/transfer preferred.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.