Alexion Pharmaceuticals Manufacturing Associate in Ireland
A key member in supporting the execution of operational readiness in Alexions manufacturing facility. The manufacturing associate will become SME in a number of unit operations throughout the process and is responsible for executing batch operations as per standard operating procedures under limited supervision.
Operate manufacturing equipment and instruments
Complete assigned tasks in a timely manner
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
Routinely draft and revise standard operating procedures and master batch records
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
Train other staff.
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
Aseptic Filling with RABS in grade B background
Compounding / Formulation of products
Sterile Filling of vials / syringes using Isolator
Visual Inspection of finished product.
Cleaning and Sanitation of equipment
Operation of Parts washers and Autoclaves
CIP /SIP of Vessels.
Creation and revision of Documents
Support regulatory audits
Support all new product/process introductions on site.
Perform data collection, compilation, and statistical analysis
Interact with vendors and outside resources
Complete assigned projects
Be the shift lead if required, providing instruction to the team
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 Environmental monitoring as required.
Technical expert for entire area(s)
Interact independently with regulatory agencies
Develop and provide training on complex manufacturing processes
Perform Manufacturing review and approval of critical documents
Develop process validation protocols
Maintain good housekeeping and clean and sanitize classified areas as required.
Analyze complex problems and determine and implement solutions
Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
Must be able to read, write and converse in English
Must have good working knowledge of MS Excel and Word
Ability to work in an intense, fast-paced 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 2 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.