Director, Production Operations

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Director, Production Operations will be responsible for the development management, execution, and continuous improvement of the operations at Kindeva Northridge site, inclusive of both Miultidose Inhalers (MDI) and Transdermal Patch manufacturing operations staff of both the MDI and Transdermal value streams.  MDI manufacturing includes the formulation, filing and spray testing, inhaler device assembly, labeling, packing, and serialization of finished MDI product. Transdermal manufacturing includes formulation and drug adhesive coating processes, patch conversion from roll stock, packing, labeling, and serialization of finished transdermal patch product.

This role assures strategic alignment to the vision and operational plans to assure the achievement of the site and business objectives and meet contemporary regulatory and Kindeva values.  The leader assures clarity, alignment, and direction is provided to the team, and partners cross functionally to create business plans and manufacturing forecasts and ensures cross functional alignment and support of the production schedule.  The position is responsible for collaborating with quality assurance, quality control, validation, engineering, technology/device, supply chain, and regulatory departments in order to ensure that regulatory standards, company policies, and site processes are met.  It manages resources to support demand and requirements for business needs and maintains a balance between the 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.

ESSENTIAL ROLE DUTIES AND RESPONSIBILITIES

• Lead of MDI combination device assembly labeling packaging and operations, 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 MDI and Transdermal value stream operational responsibilities.
• Engagement and support from Operations 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 manufacturing operations and site operations, management spending, and inventories that align with fluctuations in product demand.
• Partner with Quality and lead OpEx through the manufacturing team to ensure consistency 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 objective -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 yield and efficiency.
• Develop and execute protocols to evaluate and improve manufacturing processes; maintain an active role in CAPA investigations and required reporting.

REQUIRED SKILLS AND EXPERIENCE

Education and Experience:

• A bachelor’s degree plus a minimum of 10 years of experience or a Master’s degree plus 8 years of experience is required.
• Minimum 8 years prior management experience required, including experience working in and leading functions in cGMP manufacturing. CDMO experience highly preferred.

Key Abilities:

• Problem Solving and Innovation:   Develop solutions to complex problems that require the regular use of ingenuity, innovation, and creativity.  Ensure solutions are consistent with organizational objectives.  Adapts and responds positively to a variety of situations and people to meet changing department priorities.
• Discretion, Latitude, Level of independence; Performs work without appreciable direction. Exercise latitude in determining objectives of assignment.  Interpret policies and procedures that typically affect subordinate organizational units.  Recommend changes to operating policies.
• Impact and Organizational Contribution:  Ensure that operational priorities and projects are completed on schedule and within budget.  Monitor and manage efforts of colleagues and subordinate leaders to achieve delivery of short-term to mid-term goals.  Lead and motivate others, generating commitment and a shared sense of purpose.  Empower others to contribute their best.
• Teamwork/Influence:  Frequent contact with internal and external personnel at various management levels concerning operations or scheduling of specific phases of projects or contracts.  Actively involved in daily operations.  Accomplishes results through experienced staff colleagues.

PREFERRED QUALIFICATIONS:

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; familiarity with pharmaceutical tech transfer, NPI, and project management experience highly desirable.

Physical Requirements:

• Position requires the ability to sit and/or stand for extended periods and to work in a variety of settings, including office areas, fast-paced manufacturing areas, warehouses, etc.
• Must be able to access all work areas.  Routinely climbing stairs as necessary.
• Use of eye protection, gloves and other PPE is required.

NON-STANDARD WORK SCHEDULE/TRAVEL or ENVIRONMENT REQUIREMENTS:

• 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.
• Position requires the ability to simultaneously multitask across multiple capacities, functions and manage 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.

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