Purpose:

To produce API product material as per organizational needs in line with all relevant compliance requirements.

To lead and facilitate the safe operations of the API Small Scale (SSC) manufacturing team in a pharmaceutical processing facility in line with all safety, regulatory and operational requirements.

Responsibilities:

· Supervision and execution of pharmaceutical processing activities in the API SSC building and support locations, to meet clearly stated operating objectives. Daily reporting on the status of all operations and support activities.

· Team leadership, motivation and direction to maximise the effectiveness of their manufacturing team. The Technical Shift Leader must clearly communicate task details and goals to their team members, to allow the pharmaceutical technicians to work effectively.

· Responsible for verification and update of manufacturing control system transactions accurately and in a timely fashion.

· Act as key point of technical contact for API SSC Business Unit. Shift technicians report directly to this role.

· Communicate the departmental goals, to provide cost effective products as part of the AbbVie Class A supply chain system.

· Liaise with Supply chain & program management group to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing.

· Resolves operations/project issues by working with team members, project customers, and others as appropriate.

· Responsible for driving operations excellences and Key operations targets including OEE where applicable.

· Ensure the execution of pharmaceutical processing activities in the API building and support locations, to meet clearly stated operating objectives.

· Responsible for manufacturing compliance with all safety, environmental and quality related SOPs.

· Drive safety improvements and initiatives across the operation.

· Ensure successfully review, amendment and implementation of changes to SOPs and managing CAPAs.

· Promote a culture of perfect performance and Enhanced Right first time within their team.

· Liaise with the relevant departments & customers in the introduction and execution of NPIs Projects.

· Adheres to and supports all EHS & E standards, procedures and policies.

· Work closely with the other Technical Shift Leaders to ensure interdepartmental activities are planned and executed safely.

· Develop direct reports by securing appropriate training, assigning progressively challenging tasks and managing mid-year and annual reviews.

· Assist and cooperate with HR in the management of employee relations issues.

· Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.

· Maintains personnel records on UKGpro and makes modifications in the database to reflect actual changes.

· Assist in the identification, implementation and execution of key API and Site Strategies.

· Schedules human and material resources within a department or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.

Supervision Received

· Operates in an environment which is largely self-managed but with supervision through the API Manufacturing Manager.

· Individual is given authority to carry out their duties without close supervision.

· Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.

Supervision Provided

· 6-8 direct reports over 2 manufacturing shifts.

· May provide cross training and guidance to new department members.

· May supervise and lead projects and develop training.

Qualifications

· Degree, Masters or PhD in Life Sciences or a Process/ Chemical Engineering discipline.

Job/Technical Skills

· A minimum of 5 years experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry. Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.

· Background as a technical leader in either a process engineering, formulations and technical transfers capacity.

· Experience of start-ups and/or new product introductions to pharmaceutical facilities. Must be able to lead & project manage these activities.

· Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements. Previous exposure to supply chain & schedule delivery in a manufacturing environment.

· A minimum of 1 year previous experience of supervising a team environment with active participation in proactive improvement programs is preferred.

· Suitable direct supervisory experience or training.

Cognitive/Business Skills

· Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures.

· Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.

· Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others' participation in the continuous improvement program; investigates and solves problems that impact work processes and personnel within a unit or

department.

· Is results driven striving to meet all targets and metric standards as set by department/site and division leaders.

· Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.

· Requires total commitment to quality and maintaining a high standard of work at all times.

· Demonstrates the highest levels of integrity and a strong work ethic at all times.

· Strong communication skills both verbal and written are required for the execution of this role.

· Strong interpersonal skills are required.

· Supports the principles of Perfect Performance.

Ownership/Accountability

· Schedules human and material resources within a department or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.

· The position has a high level of autonomy and individuals are expected to work on their own initiative.

· Shows a high level of tenacity to ensure closure of issues.

· This position is crucial in maintaining the compliance of validated systems ensuring that any changes or modifications are documented and actioned.

· Demonstrates an ethos of Right First Time at all times.

· Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.

Influence/Leadership

· Is a site SME on API Manufacturing issues and provides guidance on same.

· Contributes to the successful delivery of site CJRs and Goals.

· Leads the delivery of new API initiatives.

· Provide technical leadership to functional areas and collaborates with key

stakeholders.

Decision Making/Impact

· Expected to handle day to day API Operations issues within established policies, procedures and guidelines if major problem can refer to API Manufacturing Manager.

· Responsible for the presentation of technical data to stakeholders to ensure prompt decisions on API Operations related issues.

Additional Information

So, are you ready now lead this ambitious and diverse Manufacturing team? Apply today!

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