YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Director Formulation and Device Management, are to: 

• Apply expert knowledge and skills in development activities to develop robust formulations and manufacturing processes, and to improve protein formulations and drug product manufacturing process;
• Plan, design and conduct studies with emphasis on troubleshooting, formulation/process development and improvement, scale up and process transfer;
• Develop new protein formulations and drug delivery systems and carry out other process development activities covering a wide variety of complex and diverse development projects and collaborates with others to ensure the success of those projects;
• Evaluate scientific data, apply knowledge and skills, and exercise sound technical judgment to make appropriate decisions for optimal development of protein formulation and drug product manufacturing process, and to solve a wide range of related difficult scientific/technical problems;
• Lead process development teams on major development projects including clinical manufacturing and process transfer and represent the functional group on project teams;
• Apply GMP requirements to drug product manufacturing process development, clinical drug product manufacturing, and process transfer activities based on scientific understanding of the process;
• Identify and propose external scientific advances and novel technologies with potential impact to company’s portfolio;
• Establish a network with internal and external experts in field of expertise;
• Identify "leading edge" technology in biologics formulation and drug product development at a time early enough to allow the company to obtain a proprietary position or substantial lead time on the competition;
• Be recognized as a leader in protein formulation and protein drug product development functional area

This role is open to applicants that require domestic application.

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:

• Ph.D. in Pharmaceutics/Pharmaceutical Chemistry, Chemical Engineering, Biochemistry, or a related field with at least 12 years of relevant experience in Pharmaceuticals and/or Biotechnology industries;
• Recognized as a leader in and have demonstrated ability in protein drug product development and process development;
• Broad knowledge of Pharmaceutical Sciences/Pharmaceutics/Pharmaceutical Chemistry, Physical Chemistry, and Biochemistry;
• Wide understanding for biologics drug product development from early development stages, through scaleup and clinical manufacturing, to commercial launch;
• Proven record of creativity, initiative, analytical and conceptual thinking;
• Demonstrated ability to independently design, execute, analyze, and interpret experiments, systems, methods development, validation, scale-up or operations;
• Demonstrated ability to independently troubleshoot problems requiring original thought;
• Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining results;
• Ability to solve complex and diverse development problems requiring original thinking and deductive reasoning;
• Ability to apply scientific principles to the design and interpretation of scientific experiments;
• Demonstrated success for technical proficiency, scientific creativity, collaboration with others and independent thought;
• Proven record of successful partnerships in cross-functional teams;
• Previous experience in a leadership role in a team setting;
• Demonstrated ability to present scientific/technical work internally within the company and externally;
• Excellent verbal and written communication skills including writing of scientific and technical reports and presentations.