Manufacturing Second Shift Supervisor

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows.

Summary:

The Manufacturing Shift Leader is a hands-on position. The Shift Leader is responsible for performing and leading manufacturing activities in a cGMP environment. The scope of the position includes writing and revising SOPs, Production Batch Records (PBRs), Forms, and validation documents. This individual will train Manufacturing Technicians to perform work in a safe, accurate, and timely manner, assuring cGMP compliance. Duties also include assisting with the development of processes, specifications, validation protocols, and other validation and engineering-related documentation. The person in this position may also perform routine preventive maintenance activities and manage validation and revalidation projects. 

Essential Duties:
• Work in a safe manner by 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 the compilation and review of log packets.
• Review, revise, and write SOPs and Forms to ensure they accurately reflect the current procedures.
• Lead team in maintaining all manufacturing areas by 5S.
• Lead training of other manufacturing team members.
• Assist with the execution and review of validation protocols for manufacturing/support equipment.
• Independently champion manufacturing or facility-related improvement projects, continuous improvements, or cost savings opportunities.
• Coordinate manufacturing, calibration, and maintenance activities with other departments.
• Mentor Manufacturing Technicians and team lead.
• Organize, prioritize, and execute manufacturing activities for assigned shifts to most efficiently meet the manufacturing schedule.
• Ensure team compliance with Summit Biosciences, Inc. Employee Handbook.
• Communicate the status and output of each unit operation for responsible shift.
• Deliver results for safety, quality, waste reduction, and operational excellence.
• Assist or lead investigations to resolve manufacturing incidents and deviations.
• Complete performance reviews and continuously coach team members by providing developmental feedback.
• Ensure the facility is opened before the start of the shift and secured at the end of the shift.
• Provide leadership during the off-shift to all site personnel.
• Participate in administrative tasks such as timecard approval, budgeting, recruiting, and performance reviews.
• 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 GMPs
• Demonstrated mechanical problem-solving skills.
• Documentation error rate of less than 3%.
• Less than two Quality events in a year.
• Must have legible handwriting.
• Develop strong relationships and lead a 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.

Qualifications:
• BS in a scientific discipline or equivalent experience.
• Preferred at least 3 - 5 years of applicable experience in GMP pharmaceutical manufacturing environment or equivalent experience.
• Qualified to work with controlled substances.

EEOC Statement:
Kindeva Drug Delivery/Summit Biosciences is an equal opportunity employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or any other characteristic protected by applicable law. We are committed to creating a diverse and inclusive workplace that values and supports all employees.

California residents should review our Notice for California Employees and Applicants before applying. 
 
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