CMO Specialist - Ireland
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- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Come join our team and make a meaningful impact on patients’ lives.
- Our company has a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, energy and motivation are key role requirements, as well as excellent organisational skills.
- The CMO Associate will serve as an integral member of the CMO & Supply team in a biologics facility which incorporates drug substance manufacturing and labeling & packaging of finished product. The individual is responsible forcoordinating packaging activities outside the Shanbally facility and ensuring commercial product supply needs are defined and met.
- The CMO Associate will also have a close working relationship with the Quality group and with the Artwork Department Center of Excellence in USA.
- The CMO Associate will fulfill a co-ordination and task management & execution role in support of, routine packaging production at contract packaging sites, and
- Operational readiness activities for the introduction of a new packaging process to a CMO site.
- Actively supervise the contract manufacturer relationship; i.e. communicate the details of routine work items, coordinate internal resources to accomplish project and supply goals.
- Facilitate issue resolution and problem solving with contract manufacturers
- Communicate with members of the CMO and Supply group, and with other departments, as needed to optimize the production schedule.
- Co-ordinate and publish metrics, KPIs, etc. in relation to packaging operations performance and adherence to plans.
- Execute relevant transactions to maintain product and component inventories on ERP system (Oracle)
- Develop metrics to measure and track contract manufacturer performance and schedule adherence.
- Troubleshoot equipment and process failures. Follow-up on variance reports generated during production efforts.
- The CMO Associate will fulfil the role of change control and deviation author through Trackwise for change controls and deviations/Quality events associated with routine business at CMOs, i.e. component destruction, quality events, controlled document changes, equipment and process changes, etc.
EDUCATION AND EXPERIENCE
- A minimum of 4 years experience working in a highly regulated manufacturing environment (pharmaceutical, medical devices, etc) is required.
- Experience in CMO technical oversight will be a distinct advantage.
- Proficiency with Trackwise and with Oracle or other materials management systems is desired. Excellent general computer application skills are required.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is an advantage.
- Working knowledge of GMP/GDP regulations is desired.
- Must have excellent written and verbal skills coupled with excellent interpersonal skills. Experience in Technical Writing is a distinct advantage.
- Must be quality oriented and possess a rigorous attention to detail, coupled with a demonstrated track record of delivering on goals and on initiative to institute change.
- A relevant third level qualification in science, engineering, business administration, or related disciplines.
- The CMO Associate will be required to work closely within a cross-functional team and coordinate activities between key contributors including
- Packaging Operations, Shanbally
- Packaging Operations and the Artwork Department Center of Excellence, Novato, CA
- Supply Chain Planning and Procurement
- Product Launch
- 3rd Party partners including packaging material suppliers