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The Product Formulation Lead will manage the Formulation Operations process at the shift level. The Product Formulation Lead is responsible for instructing the Product Formulation Technicians on how to safely operate the equipment. The Product Formulation Lead will work a continuous work week schedule as required by production demands and will have the supervisory responsibility for the Product Formulation personnel on the shift. They will be responsible for ensuring that the process complies with all cGMP and validation requirements at all times. They will work closely with Process Control resources to ensure that all product quality targets are met and that all process issues are appropriately reported, investigated, and corrected.

Responsibilities:

+ Maintain an operational knowledge of all formulation equipment and ancillary support equipment including control and communication devices used in the process.

+ Assist in identifying areas for process improvements through analysis of daily operations and process review.

+ Assist in identifying areas for health, safety, and ergonomic improvements through analysis of required tasks.

+ Assist in developing strategy for process improvements to include:

- Operational specification - Action Plan for implementation - Analysis of process improvement - Supporting documentation as required - Creating or revising Standard Operating Procedures to support the process improvement - Assist in training programs - Maintain tools & equipment required for formulation equipment

+ Assist with, operational, and performance qualifications testing.

+ Develop daily formulation priorities to assure daily goals are accomplished, complete daily production log and attend daily production meetings as required.

+ Develop departmental personnel into high performing work teams.

+ Ensure daily shift reports are generated and distributed to the Formulation Team.

+ Ensure the Technicians are properly trained to operate the Product Formulation equipment and document all work appropriately.

+ Ensure that the daily compounding schedule is communicated to the required personnel and any changes required be communicated back to Supply Chain and Bulk Operations.

+ Review of department documentation to include executed Batch Records and logbooks daily.

+ Work with the area leadership to provide timely feedback and coaching to all department personnel.

+ Assist the Product Development department with required formulation needs as required.

+ Assist, write and review departmental procedures, guidelines and technical documents as required.

+ Follow all SOP’s, safety and health guidelines and cGMP guidelines.

Physical Requirements:

+ Ability to push and pull extremely heavy tanks and lift and carry up to 40 pounds of equipment, parts or supplies.

+ Ability to wear a respirator.

+ Ability to stand while working for 12 hour shifts.

Qualifications

• 2 year Technical degree and a minimum of three years experience in regulated manufacturing industry preferred • Ability to handle multiple priorities; lead and participate in daily operational activities • Ability to work flexible work schedules • Ability to manage multiple tasks concurrently • Ability to establish, prioritize and implement tasks with minimal supervision • Ability to lead others to accomplish company and departmental goals and objectives • Strong oral and written communication skills • Ability to lead and develop a team-oriented working relationship within the operation