Provides technical and supervisory oversight and coordination of production manufacturing and packaging processes for Purdue Pharmaceuticals, LP in Wilson, N.C. This position is capable of executing 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 packaging of bulk drug production in compliance with cGMP, SOPs, FDA, DEA and EHS guidelines. Incumbent has direct responsibility for producing to the production plan so as to optimize schedule adherence and reduce cycle times. Responsible for coordination of manufacturing/packaging of Research and Development batches including clinical Research Manufacturing/Packaging. 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 also responsible for the coordination and planning of various manufacturing/packaging processes as directed.
(Describe in a series of brief statements up to five of your primary job responsibilities or activities in descending order of importance.)
1. The Manufacturing/Packaging management is directly responsible for all solid dose pharmaceutical manufacturing/packaging in compliance with all FDA, cGMPs, DEA and EHS requirements to ensure proper manufacturing/packaging controls.
2. Coordinate the daily operation of solid dose manufacturing and Packaging, which includes the scheduling of production and the assignment of personnel, to meet production requirements and organizational goals. Supervises a workforce made up of Technical Process Coordinators, Process Technicians.
3. Reinforce proper compliance with cGMP, SOPs, FDA, DEA and EHS guidelines to maintain control requirements. Maintain proper verification of bulk drug product type, lot number and expiration date prior to and during production processes. Control the manufacturing/packaging of narcotic production. Trouble shoot, identify problems, and make well informed decisions.
4. Communicate and motivate employees by making clear how their work objectives are directly linked to Purdue's overall business strategy. Also communicate strategic expectations throughout the organization and translate those expectations into specific work objectives.
5. 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. This coordination also includes additional Research and Development work including manufacturing/packaging of clinical material.
6. Partner with Quality Assurance (QA) department to effectively document deviations and draft investigations. Provide technical evaluations and CAPA's as needed to assist the QA groups.
7. Responsible for DEA compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
8. Provides technical expertise in solving production/process problems and is responsible for ensuring adherence to sound documentation practices.
9. Performs SAP batch and inventory functions as well as other computer related tasks required to meet production and scheduling needs.
10. Responsible for ensuring that all Standards Operating Procedures (SOPs) are current and training is up-to-date. Will use computer to maintain e-Doc system.
11. Responsible to meet objectives while managing spending, labor and capital to budget.
12. Coordinate among the Packaging Teams, the continuous improvement of Overall Equipment Effectiveness (OEE). Fosters a proactive approach to team building and problem solving by creating an atmosphere where personnel are comfortable providing input for continuous improvement.
13. Interacts with Operations management, engineering, pharmaceutical technology, validation, and equipment vendors to select new process equipment and as needed to resolve problems. Acts as the Operations' User in support of various Engineering and Pharm Tech projects that impact production areas/processes.
14. Exercise sound judgment when communicating at all levels of the organization.
15. Responsible for executing initiatives and strategies per the direction of management.
16. Performs other related assignments and duties as required and assigned.
17. Coordinates SME team meetings and uses appropriate Root Cause Analysis tools to thoroughly investigate events impacting product/process quality.
18. Leads meetings to be efficient and effective. Documents and communicates meeting minutes
A BS Degree in a related field (i.e. Industrial Technology Manufacturing) and 6 years minimum experience required in a production environment, preferably solid dose pharmaceuticals. May consider an equivalent level of applicable experience and/or education in pharmaceutical or related industries.
Required Experience & Technical Requirements
Incumbent must have a minimum of 4 years supervisor/leadership experience. Both solid dose manufacturing (Blending/Compression/Coating) and packaging is a plus.
Must have ability to work in a cross-functional team setting to solve problems and to accomplish the facility mission.Brief Description/Overview:
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.
Purdue Pharma L.P. - 2 years ago