Senior Director, Aseptic Manufacturing Operations

Company: Kindeva Drug Delivery
Location: San Diego
Posted on: May 10, 2025

Job Description:

Senior Director, Aseptic Manufacturing OperationsBridgeton, MO, USA Req #1613Friday, January 10, 2025Our Work MattersAt Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.The Impact You Will MakeIn this role you will drive strategic alignment with the vision and operational plans to achieve site and business objectives while adhering to regulatory and Kindeva standards without compromising quality, compliance, or values. You will provide clarity, alignment, and direction to your team, partnering cross-functionally to develop and execute business plans, manufacturing forecasts, and ensure alignment with production schedules.You will oversee the implementation of new filling suites and agreed-upon facility capabilities, ensuring operational and resource readiness to meet current and future client demands. Collaboration with quality assurance, quality control, validation, engineering, technology/device, and regulatory teams will be key to meeting regulatory standards, company policies, and site processes.This role balances the urgency of daily operations with the pursuit of long-term goals, managing resources to support business needs effectively. You will foster a data-driven decision-making culture, promoting urgency, ownership, and accountability across the organization.ROLE RESPONSIBILITIES

• Develop, assess and proactively recommend manufacturing and facility investments, actions and production plans required to generate and enable revenue, output targets, and assure safety and compliance.
• Oversee, direct, and enable implementation of new manufacturing, facility, and resource capabilities in alignment with agreed strategic investments and revenue growth plans.
• Lead aseptic manufacturing operations and ensure cGMP compliance.
• Accountable for financial performance of site, managing spending, and inventories that align with fluctuations in product demand.
• Partner with Quality and Operational Excellence to lead the manufacturing team to ensure consistent product quality; drive efforts to create a right-first time (RFT) culture, reduce and eliminate human errors, and continuously improve operational performance.
• Manage and deploy assigned Maintenance function to assure equipment reliability through proper and timely execution of preventive and corrective maintenance plans and programs.
• Manage all aspects of direct report development, including career development, performance management, training, business unit goals and objectives-setting, as well as supporting and demonstrating company values.
• Work as an integral member of the site management team, effectively interfacing with peers and direct reports to deliver on key objectives and established initiatives.
• Provide operational metrics, budgeting, planning, and organizational direction. Maintain alignment with other manufacturing sites through shared knowledge, data, issues, and common solutions to complex problems.
• Lead teams to meet all production and release requirements, maximizing yields and efficiency, and minimizing cost.
• Develop and execute protocols to evaluate and improve manufacturing processes; maintain active role in CAPA investigations and required reporting.
• Ensure a high level of safety awareness and cGMP compliant production and performance by providing training and leadership. Collaborate on processes to provide for the safety and well-being of operators, maintenance, and other personnel.
• Ensure that colleague training programs are suitable and effective to support cGMP requirements, and timely completion of assigned curriculum.
• Support and maintain a culture of continuous improvement and employee engagement.BASIC QUALIFICATIONSEducation and Experience:
  • Bachelor's degree plus 14 years of experience or Master's degree plus 12 years of experience required.
  • 7-10 years prior management experience required, including experience working in and leading functions in cGMP aseptic manufacturing and CDMO environments producing multiple products for multiple clients.Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
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Keywords: Kindeva Drug Delivery, Rowland Heights , Senior Director, Aseptic Manufacturing Operations, Executive , San Diego, California