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Operations Director

2 months ago

Dublin, California, United States Mallinckrodt Full time
Job Summary

Mallinckrodt is seeking a highly skilled Operations Director to lead our manufacturing operations at the College Park site. As a key member of the Plant Leadership Team, you will be responsible for overseeing the execution of commercial scale batch production and associated activities, ensuring adherence to cGMP guidelines and a focus on safety, reliability, efficiency, and compliance across the Operations function.

Key Responsibilities
  • Manufacturing Operations
    • Manage day-to-day operations, ensuring functional area targets, objectives, and performance criteria are understood and met.
    • Provide leadership and guidance to the site operations team and develop the operations strategy.
    • Ensure safe operation of work is always followed, and any safety risks identified are escalated/closed immediately.
    • Manage communication and escalation of any risks that may be detrimental to patient supply.
    • Develop, author, and review PBR's, SOP's, FORM's, and URS's as required.
    • Integrate and collaborate with cross-functional teams, setting operations expectations and driving execution.
    • Adhere to compliance, regulatory requirements, and cGMP. Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems.
    • Train, maintain housekeeping, and 6S in all production areas, focusing on continuous process improvement using Lean Principles.
    • Ensure that documentation standards within the Operations facility are maintained to a very high standard of GMP readiness.
    • Support Commissioning, Qualification, Validation, and Technical Support activities.
  • Warehouse, Planning & Logistics
    • Oversight of all aspects of warehouse operations, including general housekeeping, allocation of material, timely receipt of goods, and shipping of finished goods.
    • Leadership, development, and motivation of the warehouse team to ensure set targets are met.
    • Oversee the use of SAP to maintain full traceability and accountability of materials, including investigating any variances arising from these.
    • Accountable for the manufacturing schedule and adherence to plan. In collaboration with the production planner, develop, manage, and adjust the manufacturing schedule to meet functional requirements and commercial demands.
    • Management and oversight of scheduling of equipment preparation activities to meet the operating requirements of the Operations function.
    • Work in partnership with Mallinckrodt Procurement to manage the performance and relationship of relevant suppliers.
  • Performance Metrics, Budget & Cost Control
    • Develop KPIs and provide leadership and coaching to accomplish the company goals and objectives.
    • Monitor Operations, Quality, EHS, and Cost metrics to ensure that functional goals and targets are met.
    • Management of the monthly budget against a challenging balance scorecard.
    • Development of annual Operations Budget, including management of monthly accruals with cost control.
  • Continuous Improvement
    • Support the identification, prioritization, and implementation of College Park's Continuous Improvement projects to improve efficiency and effectiveness of site processes.
    • Facilitate an environment of continuous improvement, open communication, collaboration, and teamwork to ensure that work targets and Hoshin project deliverables are met.
    • Lead/participate in improvement projects, vendor inquiries, and troubleshooting of process equipment.
  • Leadership Responsibilities
    • Lead by example and strive to perform to high standards at all times. Act as a role model for all colleagues on the College Park site.
    • Active member of the Plant Leadership Team, contributing to developing strategy, setting G&O's, and Budget Management.
    • Provide leadership and development of all colleagues within the Operations function to ensure that goals, targets, and expectations are communicated clearly.
    • Translate business goals into departmental and individual goals and clearly communicate goals to the team.
    • Provide coaching and feedback to the team and individuals to enable them to perform effectively.
    • Work as a strategic partner with all other functions in the company and to align across Mallinckrodt.
    • Lead/participate in cross-functional teams/ad-hoc projects, goals, and objectives as they arise.
    • Integrate and collaborate with cross-functional teams, setting the operations expectations and driving execution.
    • Promote employee engagement through one-to-one coaching. Coach and mentor employees to ensure effective performance in their roles.
    Requirements
    • BSc in a science-related discipline (Chemistry, Engineering, Biotechnology, etc.) and/or 5-8 years of relevant experience in a cGMP commercial manufacturing environment.
    • Prior hands-on experience of operations functions within the pharmaceutical/biotech industry.
    • People management experience essential.
    • Prior experience in developing documentation protocols, reports, SOPs, batch records, and management of deviations/CAPAs.
    • Experience in troubleshooting and providing technical support for cGMP manufacturing process equipment in a cGMP processing environment.
    • The individual in this position will be able to organize their own work on a routine basis and requires minimal supervision.
    • Experience in working in start-up desirable.
    • Proficient in working with Microsoft Office packages.
    • Good interpersonal and communication skills, verbal and written.
    • Thorough, diligent, good attention to detail.
    • Collaborator with strong levels of engagement with individuals and team.
    • An ability to work independently and as a member of a team in a complex, fast-paced, and goal-driven environment.
    • High level of delivery and work completion.
    • Strong decision-making capability.
    • Demonstrated ability to lead change.
    • Working knowledge of six sigma and Lean Tools.
    • Ability to build a culture of positive engagement.
    • High levels of integrity and trustworthiness.
    Organizational Relationship/Scope

Manages a team of approx. 15 resources across operations and warehouse. Member of Plant Leadership Team (PLT) and collaborates with Quality, Engineering, EHS, Finance, Technical Operations daily. Works with the global network within Mallinckrodt and participates in global teams and projects.

Working Conditions

As per standard contract and Dublin College Park attendance and Timekeeping Policy and Hybrid Working Policy - Dublin College Park.

Infrequent travel may be required to other Mallinckrodt locations.