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Operations Director
2 months ago
Job Summary
The Production Manager will lead the teams responsible for the management of facilities and the successful manufacture, dispensing, and final assembly of all products at the company's site. This individual will ensure that the strategy, processes, administration, and tactical execution of all equipment, facilities, and physical infrastructure needs are appropriately defined to support successful business operations and regulatory requirements.
Key Responsibilities
- Provide overall leadership to teams under direct remit in the areas of safety, efficacy, cost, resources, and engagement
- Manage personnel to effectively deliver the manufacture of product meeting customer and quality standards, while also ensuring compliance with applicable quality and regulatory standards
- Direct the Facilities team and external vendors to satisfactorily deliver the operations and maintenance of site facilities, equipment procurement, qualification, calibration, and preventive maintenance program
- Under direction by leadership, develop and manage operational strategy and lean processes to reduce cost; improve efficiency, scale, quality, and safety; and demonstrate improvement in the customer experience
- Responsible for personnel activities of direct and indirect reports, including budgeting; staffing; training; performance evaluations; mentoring and coaching; and goal setting, including setting employee objectives linked to business initiatives and other key performance indicators (KPI's)
- Serve as an effective operational partner to teams spanning multiple functions, sites, and regions
- Establish processes following designated standards and quality management systems, setting and standardizing KPI's to evaluate effectiveness and improvements
- Support customer and regulatory body audits as requested; ensure training and documentation requirements are met to support regulatory standards
- Negotiate and manage the purchase of professional services and equipment in support of site operations; deliver facility projects, including construction and design, within specified timelines and budget
- Partner with site and financial leadership to develop annual operating and capital budgets; drive cost reductions in functional area of ownership; lead cost improvement priority projects in other parts of the business
- Conscientiously learn and diligently follow the requirements of the site's quality management system
Requirements
- Bachelor's degree in the life sciences, operations, engineering, or related field—or equivalent combination of education and work experience is required. Graduate degree preferred.
- Prior work experience in a biotechnology, medical device, or pharmaceutical organization is preferred.
- Working knowledge of real estate, construction industry and buildings capital improvement process is desired.
- Formal lean manufacturing certifications (Lean Six Sigma Green Belt, etc.) is preferred.
- Experience using ERP systems.
- Previous experience with facilities management and/or building maintenance, preferably in a technical capacity within fermentation or clean-room environments.
- Proven knowledge and experience in risk management and change management.
- Evident understanding and implementation of Lean manufacturing concepts.
- Working knowledge of electrical engineering, compressed dry air systems, purified water, HVAC, chilled water systems and gas systems, capital equipment purchasing process.
- Proven success managing and developing people, group problem solving, and managing customer relationships in an operational or project environment; experience in multi-site teams strongly preferred.