Alexion Pharmaceuticals Manufacturing Associate in Ireland
A key member in the operational readiness of Alexions new Biologics facility. The manufacturing associate will become an SME in a number of unit operations throughout the process and is responsible for executing unit operations as per SOP in the Athlone biologics facility.
Develop and own key documents to support operational readiness including SOPs, Forms and Manufacturing Batch Records.
Become competent and trained in all areas of the Athlone biologics process including but not limited to buffer preparation, chromatography, FITs and the use of disposable technology.
SME in the use of MES, MCS, SAP and all other manufacturing systems.
Support regulatory audits.
Liaise closely with the warehouse in managing inventory and stock levels.
Support all new product/process introductions on site.
Support all CQV activities on site.
Establish, develop and own operations documents.
Process trainer for the facility on all unit operations and manufacturing systems.
Operate manufacturing equipment and instruments.
Complete assigned tasks in a timely manner with significant flexibility.
Conduct daily activities in an organized, efficient manner.
Perform simple, routine, complex, and critical operations.
Troubleshoot equipment issues, when necessary.
Ensure process equipment is appropriately maintained for operation.
Perform and document operations in accordance with cGMP’s.
Execute equipment qualification protocols and validation protocols.
Recognize and initiate process deviations.
Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
Embrace Alexion Core Competencies.
Communicate effectively, written and verbal.
Maintain training compliance.
Ensure a safe working environment for all staff
Plan daily activities and schedule operations
Perform deviation investigations and closure
Interact with other departments
Perform data collection, compilation, and statistical analysis.
Interact with vendors and outside resources.
Complete assigned projects.
Troubleshoot and resolve operational problems during processing.
Represent Manufacturing in cross functional initiatives and meetings.
Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate.
Manage multiple projects independently.
Plan and implement complex changes.
Perform Manufacturing review and approval of critical documents.
Develop process validation protocols.
Maintain good housekeeping and clean and sanitize classified areas as required.
Analyse complex problems and determine and implement solutions.
Must be able to work within and adapt to complex electronic systems such as SAP, MES, MCS and Trackwise.
Must have strong technical experience.
Must have good working knowledge of MS Excel and Word.
Ability to work in an intense, fast-paced and flexible work environment.
Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously.
Ability to work independently and as part of a team.
More than 5 years’ experience in a cGMP biopharmaceutical manufacturing environment.
• BA/BS in a scientific discipline or equivalent experience preferred
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes' list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.