Senior Director, Process Development and Analytical Sciences

The candidate should have an established track record transferring processes to manufacturing scale, as well as preparing development and analytical activities for regulatory submission. The candidate is expected to be knowledgeable in areas of cell culture, protein purification, formulation and analytical characterization and be able to utilize a broad scope of scientific and technical expertise to effectively supervise a diverse group of biochemists and engineers at BS/MS/PhD levels. The candidate should have a strong working knowledge of cGMPs and regulatory guidelines as well as experience in preparation of regulatory CMC and discussion documents. The candidate should have excellent team skills, especially coordinating activities in Development and Manufacturing. The candidate must have effective organization and presentation skills for team matrix responsibilities. Responsibilities Include: Organize and direct strategy for process development for monoclonal antibodies and recombinant proteins. Plan and manage strategy for cell culture and purification process design, optimization, scale-up, technology transfer and process troubleshooting to meet project timelines and company goals. Plan and manage strategy for analytical support of development activities as well as long term analytical needs. Direct formulation strategy for new molecules. Provide scientific and technical leadership for pre-clinical projects and projects in clinical development and technical support for commercial product. No Visa Sponsorship Available. Education Requirement: PhD in chemical/biochemical engineering, chemistry or biochemistry. Experience: 15+ years industrial experience in process development especially process design, optimization, scale-up and technology transfer. Special Skills/Abilities: Excellent oral and written communication skills are essential. The candidate must have expertise with writing/reviewing regulatory documents. The candidate should be familiar with computer software including word processing, data evaluation, software interface with process equipment and statistical design of experiments. The candidate must have demonstrated ability to supervise personnel and manage complex projects. Job Complexity: The job is complex, requiring an in depth understanding of the biological and chemical properties of monoclonal antibodies and other protein therapeutics as well as a demonstrated ability to lead others and plan scientific strategies. Demonstrated familiarity and proficiency with the skills involved in GMPs, separation technology, and laboratory analytical techniques are also important. Supervision: This position reports directly to Vice President and is expected to work independently on a daily basis. Notes: 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.Principals only, no agency calls Company: Alexion Pharmaceuticals, Inc. Location: US-CT-Cheshire Status: Full Time, Employee Job Category: Engineering Company: Alexion Pharmaceuticals, Inc. Contact: Human Resources Email: Apply by Email Address: 352 Knotter DriveCheshire,CT Fax: 203-699-9940 Reference Code: PH-SH-080202