Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards. No eye contacts allowed; prescriptive glasses will be provided. Office environment with some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.). Job Description With over 40 years of operation, the Cork site is responsible for manufacturing and supplying Active Pharmaceutical Ingredients (API) used in clinical trials and approved medicines for a range of diseases including Cancer, Parkinson’s Disease, and Depression. The Cork site is expanding to accommodate the growing needs of customers and patients, as well as the development of new APIs. What will you do? Act as lead engineer for process design, process start-up, troubleshooting, and process efficiency improvements. Lead capital projects and introduction of new technologies for the site. Develop, train, and mentor junior processing engineering staff. Lead the process engineering aspects of plant cleaning set-up and qualification. Implement equipment modifications and coordinate qualification and commissioning activities to GMP standards. Be a leader in Technology Transfer activities across clinical supply and commercial supply. Execute process engineering efficiency projects. Act as Process Safety SME on assigned projects. Lead commissioning and qualification activities (URS, PFDs, P&IDs, HAZOP, change control, etc.) for assigned projects. Raise Project Proposals as necessary for both minor and major projects to improve efficiency and resolve technical issues. Identify opportunities to optimize the production plan and create opportunities for new business. Leading Others Train plant personnel on new equipment items and modifications. Mentor and train direct reports/new team members in the team's process engineering deliverables, performing the assigned training plan and nurturing skill development and knowledge. Provide mentorship and support to Process Engineering Placement Students. Deputize for the Process Engineering Manager when required. Lead Quality and Safety investigations. Lead Audit support for both internal and external audits. Lead customer visits on site. About Us: Thermo Fisher Scientific Inc. is a leading global provider in the science sector, generating more than $30 billion in revenue annually. Our mission is to empower our customers in promoting global well-being and safety. Whether our customers are propelling scientific research, addressing complex analytical challenges, enhancing medical diagnostics and treatments, or improving laboratory efficiency, we are dedicated to assisting them. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. #J-18808-Ljbffr
At PPD, part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. Our GMP labs in Athlone are continually growing and developing, and with that, the work is dynamic – projects could include deployment of lab space, repurposing of lab space, working with vendors, to general soft facilities. Lead Facilities Coordinator Discover Impactful Work: In this role, you will join our Facilities team providing support to our local site. As a Facilities Engineer/Lead Facilities Coordinator, you will ensure the team is providing the best service for our building, ensuring routine schedules and/or new qualifications are completed, remedial maintenance support, site changes/expansions, performs and documents work in accordance with standard operating procedures and established maintenance schedules to meet regulatory requirements. A Day in the Life: Work closely with the Facilities Manager on any facilities projects within the GMP labs. Takes ownership to plan and schedule all maintenance and preventative maintenance activities, generates work orders, tracks and progresses work to completion, updating job details on the in-house system and progress to close stage. Support the site needs, responding to communication from other departments in a timely manner. Responding to real time requests to provide technical and mechanical assistance. Organizes and implements daily work schedules, prioritizes and dispatches personnel to critical tasks. Schedules work around operations to minimize impact to schedules, attends meeting with other departments to plan and schedule work. Responsible for contractors on PMs and site change projects. Performs daily walk throughs reviewing PMs & WO's to verify that tasks are being performed to the required expectations. Keeping records in an audit ready state. Ensuring all required GMP and technical documentation is generated and assuring compliance with GMP guidelines and written procedures. Manage and review service contracts, generating quotations and providing competitive prices. Assisting with the development of business objectives, plans, and budgets. Education and Experience: Relevant educational qualification ideally to 3rd level. Min. 3 years experience working in a Facilities/Maintenance role where you have responsibility for site maintenance, equipment maintenance (HVACs, boilers, etc), working with vendors, facilities and all related paperwork. Knowledge, Skills, Abilities: Decision making role. Good understanding of Lab operations and support needed within a GMP environment. Experience with utilities such as HVACs, boilers, fume hoods, etc. Experience with soft facilities. Strong understanding of GMP. Ability to adhere to laboratory policies and standard operating procedures. Proficient computer skills. Effective communication skills. Ability to work with a diverse workforce with multifaceted requirements. Ability to prioritize and coordinate resources to meet our customers' needs. Ability to work in a team environment without close supervision. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. #J-18808-Ljbffr
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Job Title: Director, PPI / Operational Excellence – Drug Substance Division Location/Division Specific Information Thermo Fisher Scientific – Drug Substance Division is a rapidly growing, dynamic contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. This role provides oversight to all divisional locations. The role is based in the United States. Time may be spent at all divisional facilities including up to 50% travel to network locations globally. How will you make an impact? The Director, PPI / Operational Excellence is a global leader of the PPI / operational function for the drug substance business. This role is key to achieving our ambitious revenue growth and productivity goals while ensuring the quality of our products and compliance of our operations. What will you do? Key Responsibilities: In collaboration with executive leadership, develop an operational excellence vision and strategy supporting the Division’s long-term goals. Mentor leaders in effectively communicating and implementing this operational excellence strategy, expectations of others, and related improvement goals within their organizations. Prioritize opportunities for process improvement, cost reduction, and operational efficiency gains through data analysis, process mapping, and benchmarking. Apply operational excellence methodologies and techniques, such as Lean, Six Sigma, and Total Quality Management (TQM) to improve overall performance. Develop the operational excellence capabilities of colleagues within the Division enabling them to proactively identify and successfully conduct improvements. Develop a culture of business system leadership through the use of a variety of mentor tools and methodologies, such as important metrics leadership, tiered daily management systems, Gemba walks, and leader standard work. Lead the Divisional PPI Steering Committee to ensure an active pipeline of continuous improvement projects aligned to business priorities, metrics, and results. Collaborate with leaders to identify and track relevant metrics for measuring progress and taking corrective actions. Collaborate with collaborators and support functions (e.g., IT, Quality) to identify, evaluate, and deploy technology solutions that support operational excellence initiatives. Champion a culture of continuous improvement, innovation, and quality by engaging employees, promoting open communication, and recognizing achievements. Stay updated on emerging trends, standard methodologies, and regulatory requirements related to operational excellence, ensuring the organization remains up to date. Regularly report to the executive team on the progress and the impact on the organization's performance. Experience: 10+ years of related experience leading operational excellence, process improvement, or quality management in a large, complex organization. Black-belt Certification in Lean, Six Sigma, or other recognized methodologies. Use Six Sigma Black Belt experience with statistical software like Minitab and/or R, and new technologies like AI models, to analyze technical data for improvements. Experience leading kaizen events including elements such as standard work, process design, SIPOC, strategy deployment, A3 Thinking, value-analysis/value engineering, error-proofing, material flow, Heijunka, and kanban. Consistent track record in moving strategy into action and delivering measurable business results through the implementation of operational excellence initiatives. Strong analytical, problem-solving, and data-driven decision-making skills. Excellent communication, facilitation, and social skills, with the ability to build positive relationships and influence collaborators at all levels. Demonstrated experience in organisational change and leading cross-functional teams. Proficient in using data analysis and visualization tools (e.g., Tableau, Power BI). Experience in deploying technology solutions to support operational excellence initiatives is a plus. Familiarity with industry-specific regulations and standard methodologies for operational excellence. Understanding of applicable regulatory requirements and industry mentorship (esp. FDA, EMA, ICH, ISPE). Audit experienced is preferred. #J-18808-Ljbffr
Associate Research Scientist (Technical Lead) Biopharma - PPD Athlone, Ireland At PPD, part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Location/Division Specific Information Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. Discover Impactful Work: The role of Associate Research Scientist is responsible for the regulatory and scientific conduct of development, validation, and release/stability projects in the Biopharmaceutical Laboratory. Performs troubleshooting across multiple assay formats, clients and cell lines. Calculates and interprets data and records data in adherence with PPD SOPs and any additional requirements specific to the lab and/or client. A day in the life: Independently performs analytical testing, method optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and completes experiments independently. Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents. Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents. Communicates data and technical issues to clients on a weekly basis (or as needed). Provides technical mentorship and training to staff. Leads analytical (procedural and instrumental) troubleshooting sessions. Assists in preparation and implementation of SOPs and quality systems. Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. Education and Experience Degree or equivalent in Chemistry or Biochemistry In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Knowledge, Skills, Abilities Knowledge of general chemistry/separation techniques (HPLC, icIEF, capillary electrophoresis, ELISA). Proven experience of method development of identity and purity assays. Ideally experience in leading CMC studies for biopharmaceutical products including method validation. Proficiency on technical operating systems. Proven problem solving and troubleshooting abilities. Ability to independently perform root cause analysis for method investigations. Proven ability in technical writing skills. Time management and project management skills. Good written and oral communication skills. Ability to work in a collaborative work environment with a team. Ability to train and mentor junior staff. Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. #J-18808-Ljbffr
