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 performs and leads manufacturing activities on the second shift in a cGMP environment. Second shift hours are 3:00 PM - 11:30 PM, Monday - Friday. 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 safely, accurately, and timely, assuring cGMP compliance. Duties also include assisting with developing 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:Lead activities to manufacture sterile nasal spray products in a cGMP environment.Organize, prioritize, and execute manufacturing activities for assigned shifts, including process and cleaning validation to support commercial cGMP manufacturing.Implement, optimize, and troubleshoot manufacturing processes and equipment.Maintain areas and manufacturing documentation in compliance with SOPs and cGMPs.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.Provide communication regarding the status and output of each unit operation for the responsible shift.Coach team members and provide developmental feedback.Deliver results for safety, quality, waste reduction, and operational excellence.Complete PBRs, Logbooks, Forms, and other documentation.Assist in the compilation and review of lot records before submission to QA.Write and review SOPs and Forms to accurately reflect the current procedures.Maintain an inventory of supplies necessary for manufacturing.Maintain the manufacturing area neatly and cleanly.Assist or conduct investigations to resolve incidents and deviations.Coordinate manufacturing, calibration, and maintenance activities with other departments.Write, execute, and review validation protocols for manufacturing support equipment.Independently champion manufacturing or facility-related improvement projects.Participate in the performance of routine preventive maintenance on facilities and equipment.Help identify continuous improvement and cost savings opportunities.Lead investigations related to manufacturing deviations and assure thoroughness of the investigation, identification of root cause, documentation and closure.Other duties as assigned.Qualifications:BS in a scientific discipline or equivalent experience.3 - 5 years of applicable experience working in a pharmaceutical manufacturing environment including hands-on manufacturing or validation experience.Experience with sterilization processes or aseptic technique preferred.Hands-on experience in equipment troubleshooting and repair.Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems, cleanrooms, and pharmaceutical processing and plant equipment.Motivated to perform work while maintaining a focus on long-term learning and self-improvement.Must be flexible, adaptable, self-motivated, and able to work well independently and across teams and partners.Ability to work in a lean, action-oriented organization and demonstrate a strong work ethic.Good written communication skills to write SOPs and other cGMP documents.Excellent organizational skills and attention to detail.Strong leadership and interpersonal skills and the ability to work well in a team environment.Experienced with Microsoft Word and Excel.Qualified to work with controlled substances.Kindeva is an Equal Opportunity Employer. Summit Biosciences does not discriminate based on 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 based on qualifications, merit, and business needs.
