Manufacturing Team Lead - 2nd Shift

Responsible for independently performing and leading routine tasks in the manufacturing of nasal spray drug products with supervision.

Essential Duties:

• Work in a safe manner in accordance with site procedures.
• Adhere to cGMPs and SOPs.
• Lead team in following Production Batch Records (PBRs) to operate, monitor and control equipment and process parameters during manufacture.
• Lead team in following SOPs to clean, sanitize and prepare process equipment and rooms for manufacturing. 
• Complete PBRs, Log Books, Forms and other documentation. Assist in compilation and review of log packets.
• Review and revise SOPs and Forms to ensure they accurately reflect the current procedures.
• Maintain assigned manufacturing area in accordance with 5S.
• Lead training of other manufacturing team members.
• Assist with the execution and review of validation protocols for manufacturing/support equipment.
• Recommend and implement manufacturing or facility related improvement projects, continuous improvements, or cost savings opportunities.
• Assist in coordinating manufacturing, calibration and maintenance activities with other departments.
• Mentor Manufacturing Technicians.
• Understand daily priorities and organize daily activities and job assignments within designated process operation.
• Ensure team compliance with Summit Biosciences, Inc. Employee Handbook lunch and rest policies.
• Report daily progress to Manufacturing Management.
• Set the pace of the operation to ensure work is performed in a consistent manner while maintaining high safety and quality standards.
• Other duties as assigned.

Knowledge, Skills and Abilities:

• Technician I for two years and cross-trained in five training module areas plus 50% in all other areas.
• Good understanding of GMP’s
• Demonstrated mechanical problem-solving skills.
• Documentation error rate of less than 3%.
• Less than two Quality events in a year.
• Must have legible handwriting.
• Develops strong relationships and leads team to achieve results.
• Leads team during problem solving and understands two – three problem solving methods.
• Well-developed written and verbal communication skills.
• Demonstrates self-control to others when dealing with stressful situations.
• Outstanding capability to be flexible, adaptable and self-motivated in response to changing conditions and schedules.

• High School Diploma or GED
• Preferred at least 3 - 5 years of applicable experience in GMP pharmaceutical manufacturing environment or equivalent experience.
• Qualified to work with controlled substances.