•Responsible for supervising production related activities in Building 5 to ensure manufacturing goals are met.•Facilitate and verify appropriate training for all employees on the shift (including but not limited to cGMPs, job skills, safety, etc.).•Ensure assigned projects and deliverables (i.e. corrective actions, exception reports, meeting action items, etc.) are completed per the commitment date.•Identify, lead, and implement initiatives to drive continuous improvement in Building 5.•Implement systems to maintain compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines, FDA, and any other regulations that apply.•Ensure 100% compliance with established department procedures and regulations in producing high quality therapeutic products. •Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results, as well as, utilizing the talent management process.•Interface with computerized (automated) manufacturing control system.•Be present at the shift transition with the outgoing shift supervisor(s) as well as ensure proper shift transition/communication to the next incoming shift.•Chair the QIT 0 meeting of their respective area.•Spend a minimum of 80% of their shift on the manufacturing floor, as feasible.

The Building 5 Supervisor is responsible for implementing and supervising daily activities in Building 5 to ensure manufacturing goals and project deadlines are met by the commitment date while maintaining compliance with the current manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. He/she is expected to drive results to support plant strategic imperatives. He/she must enforce company rules and regulations and promote Shire Values within his/her shift. He/she is expected to coach/mentor employees to drive performance. He/she must be able to prepare and present technical reports and trends. He/she must have the ability to manage multiple priorities in a manufacturing plant setting, and prioritize responsibilities of self and direct reports appropriately. He/she must have organizational and administrative skills. He/she is expected to set the example for all other employees of Shire. The direct reports of supervisors observe the behavior of their leadership and interpret that behavior as acceptable. Supervisors must promote the appropriate behavior, compliance, cleanliness, and culture of Shire.

• Coordinate and delegate job assignments and responsibilities as needed to ensure production goals are met.• Assumed Interim Supervisory duties in absence of supervisor.• Strictly ensured Baxter’s cGMP’s, cGDP’s, SOP’s and safety regulations are adhered to on a daily basis.• Responsible for the hands on execution of all activities in the production area.• Accountable for and involved in all production processes.• Inspected daily compliance walk through during shift change.• Evaluated document section reviews to ensure 100 percent accuracy.• Aided on root cause investigations for exception reports/ER team. Averted potential for similar errors.• Generated required documentation as needed for repairs and/or maintenance work• Demonstrated knowledge of workflow by assisting in new talent development. • Clean manufacturing and associated support areas.• Clean equipment, which may include stationary entered tanks.• Provide critical process monitoring and trouble-shooting of minor problems, may use measuring devices to make product/process quality decisions.• Provide support to Manufacturing operators and may make decisions on product acceptability.• Follow departmental safety procedures, may conduct cGMP audits of department areas.• Assist in updating SOPs.• Maintain awareness of proper handling and removal of hazardous wastes.• Perform the operations, which may include the following • Process Monitoring• Additions• Buffer/Solution make up• Set up and operation of various equipment• Suspensions, Centrifugation and operations• Other activities as determined by the supervision• Perform precipitate and paste collection from Westfalias and Filter presses.

• Follow departmental safety procedures, may conduct cGMP audits of department areas.• Assist in updating SOPs.• Maintain awareness of proper handling and removal of hazardous wastes.• Perform the operations, which may include the following :• Assist with Buffer/Solution make up• Assist with set up and operation of various equipment• Assist with Suspensions, Centrifugation and operations• Other activities as determined by the supervision• Perform precipitate and paste collection from Westfalias and Filter presses.• Perform alcohol and or buffer additions and take manual sight glass readings from stationary tanks.• Perform disposal of hazardous waste.• Maintain Fractionation Department area housekeeping in cGMP fashion. (Cleaning walls, floors, doors, drains, windows, and other general surface areas)• Perform equipment cleaning.• Empty trash containers and maintain an adequate amount of cleaning supplies.• Supports all local manufacturing operations.• Supply components, small parts, tubing, etc.• Complete relevant paperwork following cGDP/cGMP guidelines.• Participate on Continuous Improvement Teams.• Receive and distribute supplies into the production area as necessary.• Perform cleaning solutions make-up• Perform daily cleaning of the production area to maintain in cGMP fashion. (Cleaning walls, floors, doors, drains, windows, and other general surface areas)