Director, Analytical Technical Transfer Services

Alexion Pharmaceuticals, Inc.
New Haven
Oct 15, 2016
Oct 19, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Director, Analytical Technical Transfer Services

Reports to:

Executive Director, Global Analytical & Pharmaceutical Development


New Haven, CT, USA

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.

Position Summary

This Director position will lead Alexion's analytical technology transfer efforts to external Global manufacturing and Quality Control facilities for Clinical and commercial programs. This role will also provide oversight of life cycle management for relevant analytical methods within Alexion's internal and external network. This position will work closely with the Technology Transfer Group, Quality Assurance Group, and Analytical Sciences Group and own the analytical transfer activities. This position will develop the method transfer plan, manage the transfer documents, and manage and ensure timely completion of method transfer activities. Position will work closely with the stability and analytical functions to monitor trends and assay performance of transferred assays. This position will be the Global SME for analytical related deviations, investigations and work with Analytical Sciences in troubleshooting method related performance issues.

Principal Responsibilities

* Establish global guidance documents for analytical method transfers for clinical and commercial programs

* Establish robust QC data review forums to review assay performance and create a culture of continuous improvement for all testing methodologies, utilizing and promoting new technologies where appropriate.

* Collaborate with cross-functional project teams to support QC activities necessary for the management of 3rd party CMO's, as well as timing and strategies for method validation and method transfers.

* Develop and maintain strong and effective relationships with partners including Internal/external Manufacturing Facilities, Quality Assurance, Commercial Operations, Process Development, Regulatory Affairs, Human Resources, Legal and Finance leadership to insure corporate goals are met.

* Ensure robust measurement and reporting tools are developed across testing sites to enable accurate and timely reporting to senior management.

* Review and provide feedback any analytical/QC related CMC sections/regulatory questions

* Participate and provide support for analytical related topics during regulatory inspections

* Review and approval of all analytical technology transfer protocols and reports, external method SOPs and investigation protocols and reports

* Global role requiring domestic and international travel (~25%)


* Experience and expertise in analytical method transfers is required

* Strong assay skills are required

* cGMP experience and expertise in analytical laboratories is required

* Excellent written and verbal communication skills and demonstrated ability to work effectively in cross functional teams are required

* Understanding of analytical validations approaches is a must

* Experience with trending and statistical software analysis is a must.

* Ability to represent Alexion Pharmaceutical's interests, objectives and policies in a responsible manner to external parties is required

* Demonstrated leadership and managerial skills are a must. A minimum of 5 years' management experience in an analytical function is required.

* Excellent troubleshooting skills in analytical areas are required


* A Ph.D in analytical chemistry or related disciplines with a minimum of 10 years' work experience in the pharmaceutical/biotechnology industry is required