Company Name:
Alexion Pharmaceuticals, Inc.
Approximate Salary:

Location:
New Haven, Connecticut
Country:
United States
Industry:
Other
Position type:
Unspecified
Experience level:
Education level:

Development Associate II, Analytical Sciences


Alexion Pharmaceuticals, Inc.

Alexion is an Equal Opportunity/Affirmative Action Employer.

Req ID: 8250
Job Category: Process Development
Location: New Haven, CT
Posting Date: October 17, 2017

Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal. Note that you will need to be connected to the VPN if you are applying away from the office.

Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to [email protected]

Position Summary

This Development Associate II will work in Alexion's Analytical Technical transfer team, in support of analytical method validation and transfer efforts to internal and external QC testing facilities for late stage clinical and commercial programs. This position will work closely with Quality Assurance, Analytical Development, Analytical Operation and internal and external QC Groups in executing the analytical validation transfer activities. This position will author validation and transfer documents, and ensure timely completion of method validation and transfer activities under minimum supervision. Position will also work closely with internal and external QC groups to monitor trends and assay performance of validated and transferred assays.

Principal Responsibilities
  • Review analytical testing procedure, method performance matrix and testing results across global testing network, provide key inputs to gap analysis reports and gap remediation recommendation
  • Author analytical validation and method transfer protocol and reports for late stage clinical and commercial programs
  • Ensure analytical transfer and validation are completed in timely fashion and Right the First Time
  • Review internal and external method SOPs, investigation protocols and reports

Qualifications
  • Strong hands on experience in analytical methods for biological products
  • Ability to conduct critical evaluation of scientific documentation and testing data
  • Excellent written and verbal communication skills
  • Strong cGMP experience, familiarization of cGMP regulations pertaining to analytical testing, validation and transfer, and expertise in analytical laboratories

Education
  • A Bachelor degree in Chemistry, Biology, Biomedical Science, or related disciplines with 5+ years' working experience in the pharmaceutical/biotechnology industry. Advanced degree is a plus but not required

*LI-DD1

New Haven, CT, United States


Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.



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