The Pilot Plant Manager effectively leads, manages and oversees all activities in the pharmaceutical pilot plant with primary responsibility for effectively planning, organizing, scheduling and executing technical transfer, scale-up, registration, process validation, and commercial, development and experimental batch manufacturing while also ensuring compliance with all applicable cGMP. The Pilot Plant Manager is responsible for ensuring cross functional communication and collaboration with product development teams, technical transfer teams and commercial manufacturing (two-shift). The Pilot Plant Manager will work to mitigate resource constraints and will escalate conflicts when appropriate to make sure the best interest of the company are prioritized. This position reports into the Sr. Director Manufacturing Operations and Supply Chain and has a dotted-line reporting structure to the Director Pharmaceutical Development.
Ensures a safe work environment for all pilot plant operations and compliance with all health and safety policies, procedures and well as compliance with cGMP requirements.
Collaborates with QA to respond to audits and inspections performed by regulatory authorities (FDA, DEA) and customers. Ensures a positive quality and compliance posture with regulatory agencies and internal/external partners as assigned
Leads, manages and oversees Pilot Plant team members. Manages the activities associated with the technical transfer, scale-up, registration, process validation, commercial manufacture, development and experimental manufacture of pharmaceutical batches.
Collaborates with key cross functional partners to define and manage workflow processes and requirements for pilot plant manufacturing activities. Actively participates in evaluating current capabilities and establishing production schedules to meet corporate objectives.
Collaborates on continuous process improvement opportunities working with various functions to optimize equipment uptime, improve quality, reduce overall cost, and reduce manpower utilization in support of business objectives.
Troubleshoots process related issues and provides technical expertise in process optimization formulation, process control and standardization of production norms.
Responsible for coordinating qualification and validation activities related to systems, utilities, cleaning and pilot plant equipment. Ensures equipment remains in a qualified state, is properly maintained and calibrated.
Develops standard operating procedures (SOPs) for the Pilot Plant area, equipment and processes.
Maintains equipment log books for all pilot plant equipment.
Ensure that OSHA standards are maintained. Responsible for maintaining a clean and safe work environment; promotes safety and safe behaviors.
Collaborates with Supply Chain to schedule equipment, obtain raw materials and manufacture batches.
Coordinate training activities to ensure team member qualifications and compliance with all applicable policies and procedures.
Responsible for DEA / Controlled substance compliance.
Must be able to motivate a team to optimize their performance and ability to meet goals and expectations.
Bachelor’s degree in chemistry, chemical engineering or related, technical science with a minimum of 8+ years of experience working in a pharmaceutical pilot plant/commercial manufacturing environment and a minimum of 3+ years of direct supervisory or management experience required. Advanced degree preferred. Strong working knowledge of solid and liquid oral dosage form manufacturing process development and equipment. Demonstrated understanding of lean manufacturing techniques. Successful demonstration of leadership, management, teamwork and technical expertise in pharmaceutical manufacturing or technical operations. Working knowledge of cGMP’s required. Knowledge of SAP and production scheduling preferred.
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.