Dir./ Sr. Dir. Aseptic Manufacturing Operations (AMLN-02264)

Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic diseases through the discovery, development, and commercialization of innovative, cost-effective medicines. Our rapid growth has created the following outstanding opportunity in Cincinnati, OH:

 

Dir./ Sr. Dir. Aseptic Manufacturing Operations

(AMLN-02264)

 

This position directs and coordinates the CGMP aseptic compounding, sterilization technologies, inspection and aseptic filling functions at the new Amylin Ohio state-of-art facility.

 

Responsibilities:Direct staff in all aspects of the preparation, sterilization, aseptic processing and filling operations by following current GMPs and procedures. Direct the new aseptic filling facility activities to ensure a timely start-up. Ensure the operations are conducted in compliance, by working with the quality organization to process the batch documentation in a timely manner, process deviations and change controls effectively, and implement corrective actions and preventative actions. Coordinate the production operations with multi-discipline team members. Manage the scheduling and planning aspects of the operation to ensure an on time delivery of the final product. Manage and develop the annual budget for the department.

 

Requirements:BS/MS in Chemical or Mechanical Engineering or other related scientific field.At least 5-20 years of pharmaceutical parenteral manufacturing and/or engineering fill finish experience under CGMP guidelines. At least 12-14 years experience in leading and supervising a management and operation staff. Direct experience in CGMP aseptic processing and filling operations (with powder filling desirable). Direct experience in sterilization technologies. Experience with process analysis and cost effectiveness by employing Lean Manufacturing and/or Six Sigma technologies with effect monitoring and metrics program. Experience in working with FDA and other regulatory agencies. Experience with capital investment processes. Experience with effective safety and training programs. Knowledge of complex sterile bulk manufacturing operations. Knowledge of Programmable Logic Controllers processes. Knowledge of high speed labeling, carton operations, kitting and case packaging technologies, other secondary packaging materials, and terminal sterilization desirable. Knowledge of analytical test methodology and equipment desirable.Demonstrated ability to recruit and retain a motivated and effective team. Demonstrated ability to work with the Quality Organization, Process Engineering, Regulatory Affairs, Validation and other Manufacturing groups. Demonstrated effective skills and competencies in leadership and teambuilding.Strong verbal communication, technical writing, interpersonal, decision making and teamwork skills. Outstanding organizational capabilities.Team player, results- and detail-oriented and able to promote change with positive results. PC proficiency with Word documents, Excel spreadsheet analysis and other applicable data analysis tools.

 

Amylin offers competitive compensation, benefits and stock options. Amylin maintains a drug and alcohol free workplace and all offers of employment are contingent upon satisfactory completion of a pre-employment drug and alcohol test. Please apply online at: http://careers.amylin.com AA/EEO Employer.

Amylin

Pharmaceuticals