Director of Operations
3 weeks ago
Role Summary
Responsible for the development, management, execution, and continuous improvement of the operations at the Kindeva Northridge site, inclusive of inhaler device assembly, labeling, packaging, and serialization of combination drug products in a cGMP compliant environment.
This role assures strategic alignment to the vision and operational plans to assure achievement of site and business objectives, meet contemporary regulatory and Kindeva standards, without compromise to quality, compliance and Kindeva values. The leader assures clarity, alignment and direction is provided to the team, and partners cross functionally to create business plans, manufacturing forecasts and ensure cross functional alignment and support of production schedule. The position is responsible for collaborating with quality assurance, quality control, validation, engineering, technology/device and regulatory departments in order ensure that regulatory standards, company policies and site processes are met. It m anages resources to support demand and requirements for business needs and maintains balance between urgency of daily operations and driving long term goals. The role creates a culture that makes decisions through data and metrics, and develops a culture of urgency, ownership, and accountability.
Successful candidates will foster an environment continuous improvement and encourage innovation to implement new technologies, products, and improvement to existing practices. They will lead in accordance with applicable guidelines, policies and in conformance with appropriate compliance standards, such as FDA’s current Good Manufacturing Practices (cGMP) and OSHA regulations.
This individual will cultivate and reinforce appropriate Kindeva values, norms, and behaviors and will provide oversight to individuals and teams on personal development, performance, and quality related issues. The position writes and delivers performance reviews and performs second level reviews as required.
Responsibilities
- Lead of IDD (Multidose Inhaler) combination device assembly, labeling, packaging, and operations, and assure cGMP compliance. Define and implement strategies and plans to achieve results as measured by established metrics and site goals.
- Customer facing engagement with front line representation for IDD value stream operational responsibilities
- Engagement and support from Operation Team towards successful new products.
- 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.
- Provide guidance and oversight to project plans.
- Ensure that colleague training programs are suitable and effective to support cGMP requirements, and timely completion of assigned curriculum.
- Develop and execute operational plans to consistently achieve production output targets.
- Management and accountability for the financial performance of the IDD department and site operations, managing spending, and inventories that align with fluctuations in product demand.
- Partner with Quality and lead OpEx through 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 all aspects of direct report development. This includes 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.
- Bachelor’s degree plus minimum of 10 years of experience or Master’s degree plus 8 years of experience required.
- Minimum 8 years prior management experience required, including experience working in and leading functions in cGMP manufacturing and CDMO.
- Prior manufacturing site leadership experience, working in highly complex CDMO manufacturing plants with multiple lines producing multiple products for numerous clients; relevant departmental, functional and site leadership; and pharmaceutical formulation development and project management experience highly desirable.
- Position requires the ability to sit and/or stand for extended periods and to work in a variety of settings including office areas, aseptic manufacturing areas, warehouse, etc.
- Must be able to walk to and access all work areas. Routinely climbing stairs is necessary.
- Use of eye protection, gloves and other PPE is required.
- Position requires regular onsite attendance – responsibilities for this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.
- Must have the ability to simultaneously multi-task across multiple capabilities, functions and manages competing priorities, including performing site and functional responsibilities, frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note: these activities may not be time bound to core hours or presence at the site.
- Must have the ability to effectively manage strict production, time, and performance deadlines.
- Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.
Equal Opportunity Employer
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.
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