Microbiologist III, Quality Control: Alexion Pharmaceuticals,Inc.

Responsiblities:

• Follow written testing procedures for environmental monitoring, water sampling, bioburden and endotoxin testing, TOC, growth promotion tests, microbial culture and identifications. Support other manufacturing activities as needed, such as: testing to support CIP, SIP, and raw materials testing for endotoxin and bioburden.
• Perform microbial testing for in-process, drug substance and drug product release and stability samples.
• Compile EM trending data
• Write and review SOPs, qualification and validation protocols and reports and technical reports as assigned.
• Organize activities of self and others as required to achieve project objectives.
• Recognize aberrant test and sample conditions and report to them to the area supervisor / manager with an assessment of the circumstances and potential corrective action if appropriate.
• Maintain knowledge of current scientific principles and theories and train other lab personnel as assigned in areas of competence.
• Order, stock, receive, label, log and inventory laboratory supplies.
• Receive and distribute test samples for QC and contract laboratory testing.
• Provide laboratory support services, clean/maintain equipment and prepare reagents/solutions.

• Perform all job functions in compliance with cGMPs and maintain accurate and legible laboratory records.

• Ensure training is current for all job functions performed. Attend all required Company training.
• May be qualified and assigned to review some laboratory data or documentation.
• Perform other related duties as assigned.

Knowledge, skills and abilities:

• The individual in this position is expected to have an in depth understanding of the QC Microbiology laboratory environment and be familiar with all basic and some complex laboratory equipment / instrumentation.
• This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary.
• Knowledge of GMPs and their application in the environment is required.
• The individual in this position will be able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.
• The ability to communicate verbally and in a written format is required.
• The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions, is expected.

Requirements

• BS in microbiology or other biological science
• 5-8 years of relevant experience; or equivalent combination of education and experience.

About Alexion Pharmaceuticals

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Employing more than 500 people worldwide, Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris^(R) (eculizumab) is Alexion's first marketed product for patients with paroxysmal noctural hemoglobinuria (PNH) a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. Soliris is approved in the U.S. and Europe in 2007, and Canada and Australia in 2009. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development.

Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, and a 401(K) plan.

Alexion is an Equal Opportunity/Affirmative Action Employer.