Manufacturing Supervisor/Manager

Summary

Responsible for managing manufacturing related activities, objectives and projects during the process of manufacturing clinical supplies, performing scale-up and validation activities and preparing for commercial launch of Summit nasal spray products. Duties may also include: writing and revising SOPs and Forms, writing, executing, and reviewing validation protocols for equipment, training manufacturing team members, interacting with vendors to identify equipment/supplies for manufacturing, coordinating manufacturing activities with other departments, and adhering to cGMPs, SOPs, and safety policies.

Essential Duties:

• Serve as technical resource and provide direct support to manufacturing team members.
• Implement, optimize, and troubleshoot manufacturing processes and manufacturing equipment.
• Develop and execute/coordinate execution of experimental protocols to support manufacturing process development and manufacturing equipment trials.
• Serve as a liaison to other departments to coordinate new manufacturing process implementation or changes to existing processes and to coordinate new equipment implementation or modification.
• Write, execute, and review validation protocols for manufacturing/support equipment and manufacturing processes.
• Work with vendors to identify, evaluate and recommend/select equipment and supplies for manufacturing. Manage vendors activities related to manufacturing equipment implementation or modification.
• Mentor and train other manufacturing team members.
• Write and revise SOPs and Forms to accurately reflect the current procedures. Provide input on batch record content.
• Independently champion manufacturing projects.
• Participate in manufacturing department budgeting activities.
• Identify continuous improvement and cost savings opportunities.
• Assist with batch manufacturing activities as required. Follow Production Batch Records (PBRs) to operate, monitor and control equipment and process parameters during manufacture.
• Complete PBRs, Log Books, Forms and other cGMP documentation to document all activities. Assist in compilation/review of lot records prior to submitting to QA.
• Assist with equipment and facility maintenance activities as needed.
• Other assigned duties as required.

Minimum Qualifications:

• Bachelors Degree in scientific related field or equivalent experience
• 5 years of experience working in a pharmaceutical manufacturing environment
• Experience with sterilization processes or aseptic technique preferred
• Good written communication skills to write SOPs and complete cGMP documents
• Excellent communication and organizational skills
• Mechanical aptitude and experience with manufacturing equipment
• Qualified to work with controlled substances
• Good interpersonal skills and the ability to work well in a team environment