Development Associate III, Analytical Sciences

Alexion Pharmaceuticals, Inc.
New Haven
Oct 06, 2016
Oct 19, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Development Associate III, Analytical Sciences

Reports to:

Manager, Analytical Sciences

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion is the global leader in complement inhibition and has developed and commercializes 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. In addition, Alexion's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Alexion is advancing the most robust rare disease pipeline in the biotech industry with highly innovative product candidates in multiple therapeutic areas. More information about Alexion can be found at: .

Position Summary

The Development Associate III is responsible for performing assigned experimental tasks to support the development and optimization of manufacturing processes or analytical/characterization methods as well as GMP stability and release testing for Alexion's biotherapeutic candidates. The Development Associate III will work in collaboration with other members of Process Development and Analytical Sciences.

Principal Responsibilities

* Independently perform procedures in the following areas: Plate based assays, , HPLC applications (SEC-HPLC, peptide mapping, Pro A HPLC, Ion Exchange Chromatography, etc), spectrophotometric applications, and gel electrophoresis (IEF and SDS-PAGE) with staining and densitometry.

* Independently develop and validate analytical methods, support characterization and investigation efforts as needed

* Represent Analytical Sciences on cross departmental project teams and provide technical input as required.

* Perform assay trending analyses.

* Develop WPDs and SOPs, qualification and validation protocols and reports and technical protocols and reports as assigned. Organize activities of self and others as required to achieve project objectives.

* Support manufacturing activities as needed, such as: testing to support process and method validations, and hold studies, etc.

* Perform testing for in-process, drug substance and drug product release and stability samples.

* Recognize aberrant test and sample conditions and report to them to the area supervisor / manager. Investigate and troubleshoot technical issues / problems. Complete investigations and recommend appropriate preventative/ corrective actions as appropriate.

* Maintain knowledge of current scientific principles and theories. Train and mentor other lab personnel as assigned in areas of expertise.

* Support other lab personnel as needed to meet lab operating needs.

* Perform all job functions in compliance with cGxPs and maintain accurate and legible laboratory records.

* Ensure training is current for all job functions performed. Attend all required Company training.

* Review laboratory data and documentation as qualified and assigned by lab supervisor / manager.

* Perform other related duties as assigned.


* A successful candidate will typically have +5 years of experience working in a relevant laboratory setting

* Knowledge of GMPs and their application in the environment is preferred.

* The individual in this position is expected to have an in depth understanding of the Biological Chemistry laboratory environment and be familiar with all laboratory equipment / instrumentation, procedures and responsibilities.

* Document procedures and data in peer-reviewed laboratory notebooks

* Order, stock and maintain inventory of laboratory supplies

* 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

* Interact with Technical Operations groups, Research and external vendors

* Communicate findings to colleagues within the group through presentations

* Proficiency with various MS Office programs, including Word, Excel, Outlook, and PowerPoint


* A successful candidate will typically hold a BS degree in Biochemistry, Chemistry, Chemical Engineering or related discipline from an accredited university with 5-8 years of relevant experience or equivalent combination of education and experience.

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 or download our App for iPhones and Blackberries.

Alexion is an Equal Opportunity /Affirmative action employer

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