YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Senior Manager ID Sterility, are to: 

• Lead special project and provide guidance;
• Interact with regulatory agencies, customers and internal auditors/inspectors;
• Represent Quality Control (QC) microbiology at operational and cross-functional meetings, prepare and present information, provide decision making support at meetings and disseminate information back to QC microbiology;
• Keep current with revisions to compendial monographs and to compendial test methods used in the microbiology division;
• Revise Standard Operating Procedure's (SOP’s) affected by these compendial changes and changes arising as a function of a Corrective Action/Preventative Action (CAPA), per approved Change Control;
• Maintain and generate requested microbiology-related reports, such as lists of qualified compendial methods for specific commercial products;
• Maintain records of method qualification/validation and other microbiological related methods;
• Troubleshoot assays and analytical instrumentation, improve existing methods used in testing to optimize efficiency wherever possible;
• Establish/maintain, minimizes workload, streamlining existing systems and ensure adherence to all appropriate guidance both internally and externally;
• Contribute to continuous improvement opportunities by developing methods coordinating validation and drafting SOP’s where necessary;
• Investigate questionable test results, write investigation/test plans, initiate and investigate Investigation Report's (IR’s) and OOS/Invalid/Unexpected reports when applicable;
• Collaborate effectively with Quality Assurance (QA) representatives to manage the initiation, investigation and closure of incident reports;
• Gather information necessary to support changes to microbiology methods according to approved procedures;
• Initiate Change Control requests in Bayer’s document management system and follows through until the completion of workflows.
   

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor's degree in a science or technical field;
• At least eight years of experience in pharmaceutical or related industry or an equivalent combination of education and experience;
• Demonstrable experience with cGMP and regulatory compliance (FDA, EMA and other international agencies);
• Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments;
• Thorough knowledge of microbiological analytical methods, compendial requirements (United States Pharmacopeia (USP),European Pharmacopeia (EP), Japanese Pharmacopeia (JP);
• Knowledge of biologics and manufacturing processes;
• Strong computer skills (Word, Excel, Access, Powerpoint);
• Prior experience in a QC microbiology testing laboratory;
• Ability to work independently with minimum supervision.

Preferred Qualifications:

• At least two years of experience in the relevant (business need) technical specialty within the field of protein characterization;
• Experience with Supply Chain logistics and Quality Release process.