A well established pharmaceutical company based in Dublin is looking for a Manufacture Manager to join their team. Working on bringing in a biologics project, this is an exciting time to join your new company as this is a new focus for your new employer. This represents an excellent opportunity for you to work on challenging and complex projects, with particular emphasis on technical transfer projects.
Reporting directly to the TILGC Manufacturing Operations Director, the main responsibilities for this role include:
- Operations Lead for a new regenerative medicine facility to be built onsite.
- Leads the technology transfer of the introduction of the product Cx601 designated for manufacturing onsite.
- Supports operational readiness for Cx601 aseptic manufacturing and filling onsite.
- Provides technical support for all manufacturing activities associated onsite.
- SME for aseptic processing of regenerative medicine in compliance with GMP and relevant regulatory requirements.
- As part of Operational Readiness lead the Cx601 Technology Transfer
- Scope includes regenerative medicine manufacturing
- Delegate tasks and communicate priorities to team members
- Develop and own the Cx601 Tech Transfer Schedule
- Liaise with QC, QA, Development Scientists, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting
- Understand regulatory requirements associated with cell culture manufacturing and communicate them to the project and operations team.
- Lead the process validation.
- Provide direction to manufacturing personnel in order to ensure that the manufacturing and ancillary facilities can be operated to optimum efficiency and in compliance with Quality standards.
- Support onsite 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.
- Complete required documentation relating to technology transfer, development and manufacturing activities for Cx601 in an accurate and timely manner. Such documentation would include (but not be limited to) Technology Transfer Plan, BMRs, SOP, Logbooks and EOPs.
As part of production operations:
- Lead and manage production operations (aseptic manufacturing, filling and packaging) and production related warehousing & logistics within the bioprocessing plant.
- Manage escalation, decision making and communication within production team.
- Driving compliance and schedule adherence to ensure the operational plan is achieved, including close out of all documentation.
- Manufacturing subject matter expert representing the manufacturing department in Internal, Global and Regulatory Audits and maintain an audit ready mindset in manufacturing areas.
- Maintain and develop quality standards to cGMP guidelines; operations lead in regulatory and customer audits (e.g. HPRA audits, Sterility Assurance, Environmental Health & Safety)
- Take ownership of environmental performance in the manufacturing area 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.
- Facilitate training and development of all production, warehousing personnel of the Bioprocessing Plant, ensuring they have the skills and knowledge to carry out their duties efficiently and safely and according to cGMP standards.
- Ensure that appropriate validations are in place in the area of responsibility (e.g. process validation, cleaning validation, aseptic validation)
General Role Responsibilities:
- 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 AGILE programme onsite.
- Ensure effective multi-discipline shift huddle and shift handovers take place.
- Advocate team problem solving. Working proactively to positively affect metrics, morale and metrics such as schedule adherence and quality attributes
- Drive the implementation of Standard Work amongst team ensuring activities are coordinated and integrated (training, housekeeping, documentation, process improvements, investigation activities etc) using an inclusive planning system.
- Uphold Company Code of Conduct.
- Ensure that they themselves perform all operations in accordance with company 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 30% during project phase.
GENERAL EMPLOYEE RESPONSIBILITIES:
- Participate fully in any cross functional training initiatives.
- Foster, in cooperation with other 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 Manager, Finance or other Officer appointed by the Board of Directors.
Science, Engineering or BioChemistry degree or other relevant field of expertise
- At least 5 years’ experience in Pharma Manufacturing including Technology Transfer preferably in the biopharmaceutical / bioprocessing field.
- Detailed and in-depth knowledge of biopharmaceutical manufacturing operations, as well as Quality and Regulatory Affairs. Familiar with regulatory requirements including EU GMP Volume 4 Annex 2 and GMP specific to ATMP (Advanced Therapy Medicinal Products)
- Experience of aseptic GMP manufacturing and filling is considered essential.
- Manufacturing experience in biopharmaceutical operations involving Cell Cultures or Regenerative Medicines an advantage.
- Previous Supervision/management experience is an advantage
- Excellent project management skills, Project Management Professional (PMP) is a plus
- Excellent written and verbal communication skills
- Flexible, agile and positive attitude / mind-set
- Excellent planning, scheduling and prioritization ability
- Excellent documentation skills and attention to detail.
- Strong Quality orientation and Safety focused.
- Ability to work under pressure & managing conflicting tasks at the same time.
If this is something you are interested in, apply now to be considered. If you are unsure of whether or not this is the best opportunity for you or want to see what other opportunities I am working on, get in touch on 014744692 or alternatively firstname.lastname@example.org