Director oF Manufacturing and Technical Services

Reports to:   Site Senior Managing Director

 

Responsibilities:

The Director of Technical and Manufacturing Services has overall responsibility to provide technical and logistic support to manufacturing.  Direct responsibilities are detailed below.

?  Responsible for manufacturing technical support.  The incumbent will oversee a group of technical personnel responsible for monitoring and troubleshooting manufacturing processes.  This group will provide technical support to manufacturing investigations as required.

?  Responsible for validation and qualification.  The incumbent will develop and administer the site validation program including process validation, cleaning validation, computer validation, and equipment qualification (IQ/OQ/PQ).  In this capacity, the incumbent will be expected to present the aspects of the validation program to international regulatory bodies during inspections.

?  Responsible for production planning, warehousing, and logistics.  The incumbent will oversee production planning and warehousing functions on the site.  This will include oversight of the development of the production plan and oversight of warehouse facilities for storage of product, WIP, and raw materials.

Knowledge, skills and abilities:

?  Experience in development and administration of a validation program in a cGMP/Biotech environment.

?  Experience in troubleshooting and providing technical support for mammalian cell based cGMP manufacturing processes.

?  Experience working with material management systems such as SAP.

?  Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.

?  The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a professional and responsible manner.

 

Education and experience: BS in mechanical, chemical/biochemical engineering or related science.  A minimum of 15 years relevant experience in a cGMP environment is desirable.

 

Alexion Pharmaceuticals is a publicly traded company engaged in the development of novel drugs for the treatment of hematologic disorders, autoimmune diseases, cardiovascular disorders and cancer.

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

Alexion is an Equal Opportunity/Affirmative Action Employer.