Operations Manager

Description

Manufacturing Operations

• Managing 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 development of the operations strategy.
• Ensure safe operation of work is always followed and any safety risks identified are escalated / closed immediately. Support the generation of safety risk assessments and the implementation of site EHS policies.
• 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 the 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.
• Training, maintaining housekeeping, and 6S in all production areas while 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 to 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 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 score card.
• Development of annual Operations Budget including management monthly accruals with cost control.

Continuous Improvement

• Support the identification, prioritisation 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 enquiries 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 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.

ADDITIONAL :

• Complies rigidly with processes that ensure intellectual property of the product / process is not compromised.
• Demonstrate flexibility in responding to and dealing with challenges as they arise
• Provide out-of-hours support when required.

Minimum Requirements

Education / Experience / Skills :

• BSc in a science related discipline (Chemistry, Engineering, Biotechnology etc.) and / or 5-8 years 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 his / her 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 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.

Disclaimer :

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.

They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

LI-KD1