Executive Director, Drug Product Technologies-PrePivotal

The Executive Director of the PrePivotal Drug Product Technologies is responsible for leading the team and serving as the primary department representative for Drug Product Technologies to interdepartmental and outside organizations.

Key Responsibilities:

• Ensure that the Drug Product Technologies vision, mission, and strategy are implemented and upheld
• Advance a diverse modality-independent portfolio of molecules to the clinic and with line of sight to successful commercialization"
• Align the PrePivotal department with Process Development and Operations overall mission and values
• Responsible for performance and career development are effectively managed for staff within the department
• Advise/educate R&D on candidates they bring forward from a Target Product Profile and final presentation standpoint
• Integrate the DPT pivotal function, proactively engage and inform them of potential issues to set them up for success in CFD ( clinical formulation development) efforts
• Establish and maintain partnership agreements with peer organizations such as Quality, Regulatory, Clinical Supply and Commercial Manufacturing
• Designate project representative responsibilities as appropriate
• Directly responsible for company-wide and department level activities (e.g. budgeting, capital allocation, project assignment, alignment initiatives, setting vision/direction/strategy and technology development)
• Participate in or organizes departmental committees to address departmental and interdepartmental initiatives
• Ensure that industry standards and best practices that fit Amgen's business needs are effectively applied
• Stay abreast of issues that may impact Drug Product Technologies business
• Represent Drug Product Technologies as a scientific, regulatory and technical expert both internally and externally
• Evaluate, resolve and/or escalate issues in a timely manner
• Responsible for developing next-generation leaders from within the function and building strong succession plans across all levels in PrePivotal DPT

Basic Qualifications:

• Doctorate degree & 6 years of Medical Affairs or Clinical Development experience OR
• Master's degree & 10 years of Medical Affairs or Clinical Development experience OR
• Bachelor's degree & 12 years of Medical Affairs or Clinical Development experience AND
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Ph.D. or equivalent in Chemistry (typically Pharmaceutical sciences) and 14+ years of relevant experience in the pharmaceutical or related industry which includes leadership of scientific project teams and successful leadership of drug product project groups
• Understand and apply knowledge of regulatory requirements for the pharmaceutical industry (e.g. FDA, ICH, and USP guidelines)
• Knowledgeable and experienced with the drug development process and requirements of regulatory submissions
• Collaborative leader
• Apply creative thinking to problem solving and research practices
• Problem-solving skills, including application of scientific theory
• Knowledge of essential office and scientific software, pharmaceutical and analytical chemistry, chemical process development of drug product, GLP, clinical and commercial manufacturing
• Experience with regulatory requirements for API/Product (CMC for IND/NDA, GLP/GMP, ICH) and drug product pre-formulation, formulation, drug product development, scale-up and manufacture as well as drug product outsourcing for clinical and commercial products

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.