Wilmington PharmaTech Company LLC
Pilot Plant Manager
Wilmington PharmaTech Company LLC, Newark, Delaware, United States, 19711
Wilmington PharmaTech (WPT) is looking for Pilot Plant Manager with GMP experience in the pharmaceutical industry to work in the Newark, DE area. The nature of this position is to safely lead the manufacturing team to scale-up processes and to develop and execute batch records and other instructions to create finished drug products. This position includes supervising the manufacturing operations staff of GMP operators, process engineers as well as training, coaching, and developing personnel and troubleshooting mechanical process equipment, such as reactors, pumps and filters; and PLC/DCS control systems. Ideal candidates should have a strong understanding of Good Manufacturing Practices, new product development projects, and pharmaceutical/chemical manufacturing.
Job Responsibilities
Ensure a safe work environment for all pilot plant operations and compliance with all health and safety policies and procedures.
Provide technical leadership and operational oversight of Pilot Plant facility.
Partner with Process Development to optimize and implement new processes at the pilot scale.
Plan, organize, direct and run optimum day-to-day operations.
Schedule activities of pilot plant personnel and ensure the tasks are completed in a timely manner.
Develop and optimize production schedules and coordinate with different functions to meet production schedules and deliver projects on time.
Coordinate and oversees pre-production checklists (cleaning, chemicals, equipment etc.).
Leads and coordinates the equipment qualification and preventative maintenance.
Write and review standard operating procedures, batch records, process deviations reports, CAPAs, and change control requests.
Train and oversee compliance with Quality Assurance policies and procedures that relate to the Pilot Plant.
Maintain thorough, accurate, legible, and up-to-date documentation required fulfilling the cGMP requirement for the plant, such as batch records, logbooks, cleaning books etc.
Maintain pilot plant in a functional and calibrated state.
Ensure that batch records and other Quality documents are faithfully and timely executed, reviewed, and retained as permanent records.
Manage plant supplies and raw materials inventory.
Develop and monitor metrics to track operational performance and improve overall operations efficiency.
Design and carry-out employee training programs
Lead initiatives for the continuous improvement of safety, quality, and operations.
Alert management to safety, quality, and equipment problems.
Other duties as assigned.
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Job Responsibilities
Ensure a safe work environment for all pilot plant operations and compliance with all health and safety policies and procedures.
Provide technical leadership and operational oversight of Pilot Plant facility.
Partner with Process Development to optimize and implement new processes at the pilot scale.
Plan, organize, direct and run optimum day-to-day operations.
Schedule activities of pilot plant personnel and ensure the tasks are completed in a timely manner.
Develop and optimize production schedules and coordinate with different functions to meet production schedules and deliver projects on time.
Coordinate and oversees pre-production checklists (cleaning, chemicals, equipment etc.).
Leads and coordinates the equipment qualification and preventative maintenance.
Write and review standard operating procedures, batch records, process deviations reports, CAPAs, and change control requests.
Train and oversee compliance with Quality Assurance policies and procedures that relate to the Pilot Plant.
Maintain thorough, accurate, legible, and up-to-date documentation required fulfilling the cGMP requirement for the plant, such as batch records, logbooks, cleaning books etc.
Maintain pilot plant in a functional and calibrated state.
Ensure that batch records and other Quality documents are faithfully and timely executed, reviewed, and retained as permanent records.
Manage plant supplies and raw materials inventory.
Develop and monitor metrics to track operational performance and improve overall operations efficiency.
Design and carry-out employee training programs
Lead initiatives for the continuous improvement of safety, quality, and operations.
Alert management to safety, quality, and equipment problems.
Other duties as assigned.
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