- Kindeva Drug Delivery/Summit Biosciences is an equal opportunity employer and considers all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other legally protected status. We are committed to creating a diverse and inclusive workplace and encourage individuals of all backgrounds to apply.
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Operations Manager - Lexington, United States - Formerly Summit Biosciences Inc. | KDD
Description
Job Summary:
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.
If you are ready to work for a purpose, the Manufacturing Manager position is a crucial role that oversees the manufacturing operations team during the process of manufacturing products, performing scale-up and validation activities and preparing for commercial launch of nasal spray drug products ensuring that all products are produced efficiently, safely, and in compliance with regulatory standards in an FDA regulated cGMP pharmaceutical manufacturing environment.
Compensation & Benefits:
This is a full-time, salaried position with a competitive compensation package including benefits such as health insurance, 401(k) plan, paid time off, and opportunities for professional development.
Responsibilities:
• Oversee the day-to-day operations of the manufacturing department, including scheduling, resource allocation, and quality control.
• Develop and implement strategies to increase efficiency and reduce costs in production processes.
• Ensure compliance with all regulatory standards, including cGMP, FDA, and OSHA regulations.
• Hire, train, and manage a team of manufacturing personnel, providing guidance and support as needed.
• Continuously monitor and improve key performance indicators, such as yield, cycle time, and waste reduction.
• Collaborate with cross-functional teams to troubleshoot and resolve production issues.
• Manage inventory levels and ensure that materials and supplies are ordered and received on time.
• Implement and maintain standard operating procedures to ensure consistency and quality in product output.
• Stay current on industry trends and best practices to ensure that manufacturing processes are efficient and up-to-date.
Requirements:
• Bachelor's degree in Engineering, Pharmacy, or a related field.
• 7 years of experience in a manufacturing role in pharmaceutical manufacturing process development, process engineering optimization, and validation.
• Strong knowledge of cGMP, FDA regulations, and OSHA compliance. HVAC systems and cleanrooms, & pharmaceutical processing & plant equipment.
• Proven experience in managing people and production processes.
• Excellent communication, leadership, and decision-making skills.
• Ability to work in a fast-paced, deadline-driven environment.
• Attention to detail, strong problem-solving skills, and excellent technical writing, communication & organizational skills.
EEOC Statement:
