Manufacturing or Production Jobs

Monitor the manufacturing/filling of aseptically filled pharmaceutical products
• Monitor product formulation, transfer and aseptic filling to identify potential problems or safety risks
• Ensure all area personnel are trained on all procedures and aware of safety requirements and potential hazards
• Aid in the calibration, preventive maintenance and maintenance validation efforts routinely required in the area
• Assist in preparation and/or revision of departmental documentation and written procedures such as standard operating procedures, manufacturing directions, investigation reports, etc.
• Proactively perform review and trending of investigation/discrepancy reports and support the proactive analysis and implementation of processes to prevent re-occurring events
• Provide technical support during product formulation, transfer and filling
• Understand and follow DEA requirements, with appropriate documentation

Maintains plant manufacturing, packaging and related equipment in peak operating condition through the performance of varied routine tasks as assigned by the department supervisor, group leader or manager.

Job Responsibilities

Adjusts or replaces machine parts as necessary to facilitate the repair and/or changeover of equipment to manufacture or package various products.

Maintains manufacturing and/or packaging equipment at required operating levels, through the performance of proper preventive maintenance and major overhauls in order to meet departmental production standards on equipment in several lines.

Follows current Good Manufacturing Practices (cGMPs), OSHA regulations, DEA regulations and good housekeeping procedures at all times.

Click Here For More Information

The Supervisor has accountability for leading assigned production staff to achieve targets and deliver and improve process or product consistency, quality/compliance, cost standards and customer service. Responsible for planning, organizing, staffing, performance assessment, salary recommendations, and employee counseling for a group of employees typically with similar technical responsibilities. Ensures that work performed by the assigned staff is accurate, timely, efficient and compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations. Leads and participates in investigations and continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and/or cycle time. Collaborates effectively with other functional SMEs to ensure production goals are met and investigations are expeditiously completed. Has a basic understanding of product cost structure, budgeting process and spending.

The Manager provides guidance and direction to supervisors (direct reports) and senior level professionals involved in process activities or production operations for the successful manufacture/packaging of Wyeth commercial or clinical products. Ensures compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practice regulations (cGMP), product licenses, corporate policies and safety practices. Leads or oversees investigations and continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma, to improve quality, cost, safety and/or cycle time. Organizes the group to deal with assignments, and plans, schedules and coordinates efforts and activities to assure completion of assigned objectives within the specified time frame and allocated resources. Functions as an advisor on projects/investigations, encourages collaboration with other functional groups, and works with staff to resolve complex technical problems.

Monitor the manufacturing/filling of aseptically filled pharmaceutical products
• Monitor product formulation, transfer and aseptic filling to identify potential problems or safety risks
• Ensure all area personnel are trained on all procedures and aware of safety requirements and potential hazards
• Aid in the calibration, preventive maintenance and maintenance validation efforts routinely required in the area
• Assist in preparation and/or revision of departmental documentation and written procedures such as standard operating procedures, manufacturing directions, investigation reports, etc.
• Proactively perform review and trending of investigation/discrepancy reports and support the proactive analysis and implementation of processes to prevent re-occurring events
• Provide technical support during product formulation, transfer and filling
• Understand and follow DEA requirements, with appropriate documentation

Performs specific assignments to ensure that equipment in various manufacturing, packaging and related areas operate properly and is maintained. Operates, maintains, troubleshoots and repairs equipment associated with the packaging of pharmaceutical products. Performs routine preventive maintenance, equipment changeovers, equipment cleaning and set-up. Performs duties with advanced skill on many different types of equipment. Applies advanced working knowledge and experience to independently improve maintenance techniques and operations.

Job Responsibilities

•Adheres strictly to all cGMP’s, PPG’s, regulatory and safety standards and procedures to ensure the quality and integrity of products and safety of employees

•Keeps working area in a clean and orderly condition according to PPG’s and 5S principles

Entereg (alvimopan) is expected to be approved during 2Q2008 to reduce the duration of post operative ileus (POI) by accelerating GI recovery following bowel resection surgery. The Product Director will be a strategic leader for the Entereg brand in the hospital market. The Director will:
•Lead the development of Strategic Plans with our co-promotion partner, Adolor.
•Lead POI medical communications / speaker programs, KOL programs and association relationships.
•Establish Entereg as an integral part of hospital and health systems efforts to improve surgical quality and outcomes.
•Contribute to clinical strategies and plans for the Entereg POI hospital / surgery patient indication, leading marketing and financial analysis.
•Fully evaluate and recommend product lifecycle opportunities (dose forms, indications) to expand the utility of Entereg to patients in the hospital / institutional environment.

Conduct Materials Management operation in accordance with cGMPs, GSK standards and dept. SOPs.

Comply with all safety related material handling procedures and equipment.

Accountable to ensure delivery, storage and inventory of materials and supplies in compliance with regulatory expectations and consistent for projects.

Effective prioritization against projects and business requirements.

Accountable for compliance with GSK quality/regulatory standards.

Contribute to development of SOPs, Materials Specifications, and pertinent area documentation.

Build sound working relationships with a range of individuals/departments both internally and externally.

Assist in developing and performing training for MM staff.

Contribute to development and issuance of metrics for inventory control, supply and forecasting.

Contribute to the implementation of business processes and best working practices to ensure MM operate as efficiently as possible.

Job responsibilities include but are not limited to performing the following duties within a team-oriented, GMP solid dosage pilot plant:
*Assemble, operate, troubleshoot, disassemble, and clean processing and packaging equipment following appropriate SOP’s and Work Instructions.
*Maintain all equipment in a state of operational readiness
*Dispense raw materials and packaging components for experimental and human-use batches
*Execute batch records, maintaining strict adherence to GMP’s and site SOP’s
*Collect samples of raw materials, intermediates and finished products utilizing appropriate sampling tools and techniques
*Perform in-process testing of batch samples utilizing various physical testing instruments
*Operate material handling equipment such as forklifts, drum lifters, and pallet jacks
*Participate in site Operational Excellence initiatives
*Provide technical expertise and assistance to project teams operating in the pilot plant or formulation suites.

Supervise, coordinate and direct the daily activities of hourly / non-exempt facility personnel engaged in the manufacturing and/or processing of product specific to functional area. Ensure staff is adequately trained in operation of area equipment and that all applicable regulatory compliance is maintained.

RESPONSIBILITIES:

• Provide all aspects of daily supervision and direction of area personnel to include managing key employee relations activities of coaching, counseling, discipline, recognition and the performance management process.

• Engage in budgeting process by gathering data to support budget requests that impact own functional area. Also responsible for day-to-day management of area specific expenditures against approved budget.

• Utilize effective planning tools/data to design, implement and execute production and resource scheduling against operational demands.