YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Senior Research Scientist, are to: 

• Designs, directs and/or conducts preformulation, formulation development, process development, process optimization, scale-up and clinical manufacturing on assigned projects;
• Serves as a technical leader in formulation, process and product development, optimization and scale-up of oral, topical/transdermal, and parenteral formulations;
• Prepares and manages multiple project budgets and capital budgets for formulation development and pilot plant groups;
• Serves as a CMC Subteam project leader for teams consisting of Chemistry, Analytical, Formulation, QA, QC, Validation, Engineering, Regulatory Affairs, Production, R&D, and Supply Chain charged with projects pertaining to formulation and process development; formulation and process scale-up, optimization, technology transfer and process validation. Coordinates team initiatives to introduce changes in formulations/processes/products;
• Provides product stewardship to insure trouble shooting the optimization of product formulations, process and technical performance in cooperation with PS manufacturing group;
• Writes and reviews protocols, batch records, batch summary reports, technical transfer documents and product development reports and other key reports/documents as per (V)ICH guidelines and regulatory requirements;
• Supports CMC regulatory submissions during filing and works closely with different departments to address any FDA deficiency letters;
• Understands project timelines and can identify/influence critical path and de-risk activities.

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:

• This position requires a PhD in Pharmaceutics or Pharmaceutical Sciences or related scientific field preferably in Formulation Development/Drug Delivery and 5+ years of industry experience or Masters Degree and 7+ years of industry experience or Bachelors Degree and 10+ years of industry experience or knowledge/experience commensurate exceptional experience;

• Emphasis on leadership skills, ability to lead technical subteams, and to understand big picture of development;

• Experience in the formulation/process development, scale-up and manufacturing of parenteral product preferred. Solid product development also welcome;

• Excellent verbal and written communications skills are essential. Working knowledge of Microsoft suite of software products including Excel, Word and PowerPoint is required;

• Strong organizational skills with the ability to multi-task and prioritize assignments are essential;

• In-depth understanding of FDA guidelines and regulations and working within cGMP requirements is required;

• The incumbent must have a demonstrated understanding of financial impact of product performance in a pharmaceutical environment;

• Bayer Key/Critical Competencies: Manages Complexity, Values Differences, Drives Vision and Purpose, and Courage.