Manufacturing Team Lead - 2nd Shift

Summit Biosciences is a specialized pharmaceutical company that develops, manufactures, and commercializes prescription nasal spray products. Summit Biosciences is experiencing significant growth and offers competitive compensation + annual bonus, 401k plan, paid holidays, PTO, health/dental/vision/life insurance, short/long term-disability, an incredible collaborative and challenging culture in a team-oriented environment. Second shift hours are 3:00 PM - 11:30 PM, Monday - Friday generally.

Summit Biosciences is an Equal Opportunity Employer. Summit Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by applicable federal, state and local laws. All employment is decided on the basis of qualifications, merit, and business need.

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.