JO-2406-536736
Biotech manufacturing
Sligo
Have you ever wondered what it is like to work in a Biotech before it goes into full scale production? Well this could just be the role for you.
This company are small at present but have a massive global presence in the biotech space, they are growing out their site in Sligo and require an Operations Manager to take the company to the next level. They have already been recognised as a great place to work and the future looks extremely bright for this hidden gem in Sligo.
This is an opportunity to add a career defining experience to your CV.
Role
• Lead, mentor and develop an expanding team of manufacturing professionals, fostering a culture of excellence, teamwork and continuous improvement.
• Develop and implement strategies to achieve production targets, quality standards and cost efficiency whilst ensuring appropriate level of preparedness of any escalations, fostering a culture of openness, collaboration and attention to detail to achieve schedule/project task delivery.
• Ensure all manufacturing activities comply with GMP, regulatory and company standards.
• Continuously maintain area in GMP Compliance and ensure operations team training is current.
• Oversee the writing and review of SOPs, batch records and other documentation.
• Manage day-to-day manufacturing operations, including scheduling, resource allocation, and troubleshooting production issues.
• Focusing on near term horizon actively assess and recognize where action is required and work to generate alternatives, generate options and choosing effective options including knowing when other stakeholders support is needed.
• Partner with Technical and Scientific Affairs (TSA) to monitor and optimise production processes to improve yield, efficiency and product quality.
• Identify opportunities for process improvement and lead initiatives to enhance operational efficiency.
• Identify and implement lean manufacturing principles and continuous improvement methodologies.
• Collaborate with cross functional teams including Quality Assurance, Quality Control and Engineering to build an effective working relationship thus ensure seamless operations.
• Participate in internal and external audits and inspections, addressing any findings and implementing corrective actions.
• Track and trend relevant metrics to ensure operations are performing effectively and efficiently.
• Actively participate in the Site Lead Team and S&OP processes to assess workload, identifying gaps or imbalances, and reallocating resources or making hiring decisions to optimize staffing levels and ensure efficient operations as the site expands with capital investments, technology transfer and commercial manufacture.
• Ensure all manufacturing activities adhere to EHS regulations.
• Work with EHS to promote a culture of safety and safety improvements within the operations team.
Requirements
• Bachelor’s degree in Life Science or equivalent. Extensive relevant industry experience may supersede degree requirements.
• Min 10 years manufacturing experience with 5 years managerial experience (preferably Site Lead)
• Proved track record of managing GMP compliant manufacturing operations.
• Experience with regulatory, client inspections and audits.
• Academic and practical experience with operational excellence and process improvement initiatives is highly desirable.
• Advanced knowledge of MS Excel, Word and PowerPoint. MS Project an advantage.
• Fluent in written and spoken English.
• Strong leadership and people management skills – this role requires management of all operations competencies.
• In-depth knowledge of GMP regulations and biopharmaceutical production processes.
• Excellent problem solving, analytical and decision-making abilities.
• Ability to prioritise workload and set direction.
• Strategic thinker with proven ability for forward planning.
• Strong communication and interpersonal skills.
• Flexible and agile in support of site’s overall mission
