QC Analyst


  • Company:
    Alexion Pharmaceuticals
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    1 week ago
  • Category:
    General

Position Summary

The individual in this position should have a working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail. The individual must be able to perform routine tasks with a minimum of supervision.

Principal Responsibilities

+ Perform all lab functions in compliance with cGMP

+ Follow written procedures for the following tests, as trained and qualified:

+ Electrophoresis (SDS-PAGE, IEF, iCE)

+ HPLC methods including Size Exclusion, Reverse Phase, Peptide Mapping, Anion Exchange.

+ Microplate assays and ELISA

+ Protein Concentration

+ Compendial Methods such as pH, Osmolality, and Appearance.

+ Stability scheduling and testing.

+ Act as an subject matter expert in relation to some or all of the techniques listed above.

+ Provide lab support including reagent preparation, cleaning, and routine equipment maintenance.

+ Recognize and report aberrant test results and sample conditions.

+ Conduct laboratory investigations to determine root-cause of invalid assays and aberrant results.

+ Ensure training is current for all job functions performed.

+ Receive and manage samples that are submitted for stability and release testing.

+ Order, stock and receive laboratory supplies.

+ Complete all required documentation legibly and accurately.

+ Provide support to Laboratory Management in developing testing schedules

Qualifications

+ A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products

+ Ability to follow written procedures with close attention to detail

+ Ability to function with minimal supervision for routine job duties

Education

+ BSc in Chemistry or a biological science, with 3 – 6 years’ experience, or equivalent combination of education and experience.

Competencies

+ Functional/Technical Skills

+ Perseverance

+ Accountability

+ Peer Relationships.

*LI-GO1

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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 the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). 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 two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. 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.

Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.