Team Lead Regenerative MedicinesApply Now Job ID R0004109 Date posted 09/03/2018 Location:Dublin, Ireland
Reporting directly to the Manufacturing Manager - Bioprocessing, the Team Lead Regenerative Medicines
- Will act as operations team lead in a new regenerative medicine manufacturing facility to be built at Takeda Ireland Grange Castle (TILGC).
- Supports the development of the site operational structure particularly with regard to regenerative medicines manufacturing.
- Will provide leadership to the operations team of plant technologists in biologics manufacturing.
- Supports operational readiness for regenerative medicines aseptic manufacturing of cell therapy products.
- Safeguards operational readiness and commercial supply of a highly strategic Takeda product.
- Provides technical support for all manufacturing activities associated with the biologics manufacturing facility at TILGC.
- As part of operational readiness
- Lead the operations team of plant technologists in biologics manufacturing
- Delegate tasks and communicate priorities to plant technologists
- Support the development of the new operations team structure.
- Understand manufacturing requirements associated with cell culture manufacturing and communicate them to the project and operations team.
- Support the site start-up phase from manufacturing side with regard to process simulation ( media fills), pilot runs and process validation.
- Liaise with QC, QA, and Logistics to safeguard the start-up schedule of the site
- Provide leadership to manufacturing teams in order to ensure that the manufacturing can be operated to optimum efficiency and in compliance with Quality standards. This includes (but is not limited to) production finite planning and production performance monitoring.
- Support operations team with achieving overall operational readiness schedule adherence.
- Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.
- Safeguard the timely and GMP compliant production of registration samples & clinical trial material
- Complete required documentation relating to development and manufacturing activities in an accurate and timely manner. Such documentation would include (but not be limited to) BMRs, SOPs, Logbooks and EOPs.
- Safeguard audit readiness incl. continuous compliance with all applicable regulations in area of responsibility.
- As part of commercial production operations:
- Lead and manage production operations (aseptic manufacturing, filling and packaging) and production related warehousing & logistics within the bioprocessing plant.
- Provide leadership to manufacturing teams of plant technologists in order to ensure that the manufacturing can be operated to optimum efficiency and in compliance with Quality standards. This includes (but is not limited to) production fine planning, production order management and production performance monitoring.
- Manage escalation, decision making and communication within production teams.
- Foster compliance and schedule adherence to ensure the operational plan is achieved, including close out of all documentation.
- Support and lead activities to improve environmental performance in own area of responsibility and work continuously to ensure the strongest environmental performance possible by proactively and constantly improving control strategies and employee engagement in this area.
- Lead and support investigations in manufacturing and technical deviations (RCAs).
- Support and facilitate training and development of plant technologists, ensuring they have the skills and knowledge to carry out their duties efficiently and safely and according to cGMP standards.
- Execute, lead and participate in product and process risk assessments and investigations.
GENERAL ROLE RESPOSIBILITIES:
- Support a culture of open communication, fairness and transparency.
- Participate in any required training and ensure team members are suitably trained.
- Drive a continuous improvement mindset in line with the Takeda operational excellence program at TILGC.
- Advocate team problem solving. Working proactively to positively affect metrics, morale and metrics such as schedule adherence and quality attributes.
- Drive fine planning activities with regard to production capacity using an inclusive planning system.
- Uphold Company Code of Conduct.
- Ensure that they themselves perform all operations in accordance with TILGC quality standards, GWPs, cGMPs and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.
- Foster a safe work environment, ensuring all colleagues maintain safety as a priority.
- Travel requirements: Up to 5% during project phase.
- Ensure effective performance management by leading shift huddle and shift handovers with the operations team of plant technologists.
Required Competency Level: 3
GENERAL EMPLOYEE RESPONSIBILITIES:
- Participate fully in any cross functional training initiatives.
- Adopt the corporate values of Vision 2025 and Takeda-ism within the workplace.
- Foster, in cooperation with other TILGC staff, an ethos of continuous improvement where CI and agility is accepted as an integral part of the overall business.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the TILGC Bioprocessing Manager
- Science , Engineering or BioChemistry degree or other relevant field of expertise.
- At least 5 years experience in aseptic manufacturing environment in the pharmaceutical/biopharmaceutical industry, preferably with experience in the leadership of teams. Experience of aseptic GMP manufacturing and filling is preferred.
- Manufacturing experience in biopharmaceutical operations involving cell cultures or Regenerative Medicines and Vaporized Hydrogen Peroxide decontamination an advantage.
- Experience in operational excellence Lean/Six Sigma, Green Belt Certification is an advantage
- Excellent planning, scheduling and prioritization ability
- Excellent documentation skills and attention to detail.
- Ability to work under pressure & managing conflicting tasks at the same time.
- Experience in electronic quality management and document systems (EQMS, EDMS), manufacturing execution systems (MES) and SAP an advantage