Job Summary

Provides technical oversight and coordination of manufacturing and/or packaging processes for Purdue Pharmaceuticals, LP in Wilson, N.C. This position can execute processing assignments independent of direct supervision and providing direct support in the achievement of facility goals and objectives.

The incumbent is responsible for the manufacturing and/or packaging of solid dose products in compliance with cGMP, SOPs, FDA, and DEA regulations and has direct responsibility for producing to the production plan to optimize schedule adherence and reduce cycle times. This position is responsible for developing and maintaining efficient and effective production processes using “best-in-class” tools such as OEE and Lean Manufacturing techniques.

In addition, the position is responsible for promoting and fostering a work environment that is safe and conducive to employee development and where Purdue’s values are demonstrated and practiced. The incumbent is responsible for supporting the operations cross-training program for developing well-trained, flexible, cross functional teams.

Primary Responsibilities

• Ensure all solid dose pharmaceutical processes are executed in compliance with all FDA, cGMPs and DEA requirements.
• Coordinate the daily operation of solid dose manufacturing and/or packaging, which includes the scheduling of production and the assignment of personnel, to meet production requirements and organizational goals.
• Reinforce proper compliance with cGMP, SOPs and FDA guidelines to maintain control requirements. Control the manufacturing and packaging of narcotic production activities and troubleshoot, identify problems, and make well informed decisions.
• Communicate and motivate employees by making clear how their work objectives are directly linked to Purdue’s overall business goals and objectives. Also communicate strategic expectations throughout the organization and translate those expectations into specific work objectives.
• Coordinate with other support departments and expedite material to ensure that production schedules are achieved. Communicate with Quality Assurance and Quality Control to ensure objectives and criteria are clear and identifiable to maintain cGMP.
• Partner with Quality Assurance (QA) department to effectively document quality events and draft investigations. Provide technical evaluations and CAPA’s as needed to assist in identifying true root cause analysis and corrective/preventative actions.
  
• Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
• Provide technical expertise in solving production/process problems and is responsible for ensuring adherence to sound documentation practices.
• Perform other duties as assigned.

Education and Experience Requirements

A minimum of 10 years pharmaceutical experience required in a production environment (preferably in solid dose production) and a degree in a related technical field; 3-5 years of direct management experience and demonstrated experience leading teams and cross-functional projects. Preferred experience in initiating and/or directing Operational Excellence programs within a dynamic team setting.

Necessary Knowledge, Skills, and Abilities

Incumbent must have direct experience in areas within the Department. Process areas are: Packaging, Manufacturing - Granulation (top spray, mixer/granulator/fluid bed dryer by solvent or aqueous), Compressing (single or double-sided press), Coating (solvent or aqueous), Extrusion, and Blending.

Incumbent must have the ability to work in a cross-functional team setting to solve problems and demonstrated ability to translate organization goals into team objectives.

Supervisor Responsibilities (if applicable)

The Senior Manager is directly responsible for all solid dose packaging and/or manufacturing processes and will oversee daily operations. Will have direct management responsibilities for Supervisors and Managers of the process areas.

Physical and Environmental

• Wear appropriate Personal Protective Equipment including PAPR (Powered Air Purifying Respirator) as needed.
• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax or other specialized equipment used in an office setting.
• Individual may move various items (i.e boxes, carts, files, etc) by hand or manual hand carts.
• Must be able to work a 10.5 hour per day/4-day work week; 40 hours per week.

Additional Information

Relocation is not offered for this position.

Purdue Pharma does not sponsor or facilitate any U.S. work or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at Purdue Pharma.

Minimum required education, experience, knowledge, skills and abilities for Senior Manager Operations are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.