Executive Director, Synthetics P&E

The Executive Director of the Synthetics Pivotal and Engineering Drug Substance Technologies is responsible for leading the team and serving as the primary department representative for Synthetics Drug Substance Technologies to interdepartmental and outside organizations.

Key Responsibilities:

• Accountable for ensuring that the Synthetics Drug Substance Technologies vision, mission, and strategy for late stage are implemented and upheld
• Accountable to rapidly advance a diverse synthetics portfolio of molecules to the clinic and commercial network
• Responsible for aligning the Synthetics Pivotal department with Process Development and Operations overall mission and values
• Ensures that performance and career development are effectively managed for staff within the department
• Seamlessly back-integrate into R&D and pre-pivotal synthetics and advise/educate them on candidates they bring forward from a Target Product Profile and final presentation standpoint
• Seamlessly forward-integrate into the commercial network and ACM, proactively engage and inform them of potential issues to set them up for success in commercialization efforts
• Establish and maintain partnership agreements with peer organizations, e.g. ACM, AS, DPT, Quality, Regulatory, Clinical Supply and Commercial Manufacturing (internal and external)
• 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)
• Participates in or organizes departmental committees to address departmental and interdepartmental initiatives
• Ensures that industry standards and best practices that fit Amgen's business needs are effectively applied
• Stays abreast of issues that may impact Synthetics Drug Substance Technologies business
• Represents Drug Substance Technologies as a scientific, regulatory and technical expert both internally and externally
• Evaluates, resolves and/or escalates issues in a timely manner
• Responsible for developing next-generation leaders from within the function and building strong succession plans across all levels in Synthetics Pivotal and Engineering DST

SCIENTIFIC/TECHNICAL

• Serves as a technical expert and keeps current in drug substance development, including literature and technology development for cutting edge and regulatory driven activities
• Provide support to Drug Substance Team Leaders for regulatory submissions, investigations, and product development (supporting ACM, DP, AS, Quality and Regulatory and clinical supply)
• Extensive knowledge of GLP and GMP activities
• Understands the technical and/or scientific capabilities of the department and provides guidance to senior staff members to resolve scientific/technical issues
• Conveys a broader level of understanding in pharmaceutical R&D and commercialization to the department
• Familiar with the drug development process and requirements of regulatory submissions
• Clearly understands and applies knowledge of regulatory requirements (FDA, ICH, USP, etc.) to completion of projects
• Oversees and upholds proper safety practices
• Leads and/or participates in technical forums for sharing of best practices and application of scientific expertise

TEAM LEADERSHIP

• Contributes to drug product development teams, providing leadership in scientific, technical and regulatory issues
• Ownership of Synthetics Pivotal and Engineering DST topics, proactively engage other PD Functions to get studies completed on time rather than waiting for other functions to complete their tasks
• Negotiates for resources identified by the group leaders and establishes priority for projected activities
• Facilitates cohesiveness and builds team spirit
• Ensures that effective teams are built and sustained within the department
• Ensures others feel respected, valued and understood

COMMUNICATION

• Communicates effectively with others, using appropriate diplomacy and sensitivity
• Organizes and conducts meetings
• Communicates in individual and group situations
• Demonstrates facilitation and listening skills
• Establishes and maintains effective communication mechanisms to keep staff appropriately informed
• Bridges communication between individuals, units and other organizations as necessary

MENTORSHIP

• Ensures that safe laboratory practices are followed
• Ensures staff are qualified by education, training and/or experience to perform their respective tasks
• Provides mentoring and expertise to less-experienced staff
• Motivates others who may or may not report directly to them
• Motivates, develops, and coaches staff while promoting team collaboration
• Applies effective management practices in the direction and development of others
• Oversees the execution of drug product development, scale-up and manufacture to support clinical and commercial small molecule candidates

LEADERSHIP & INFLUENCE

• Provides clear and consistent vision and direction
• Be ambassadors of DST and represent their function across Operations and our interfaces
• Identifies and negotiates resources and develops timelines for project activities.
• Negotiates and collaborates inter departmentally
• Provides scientific and technical leadership
• Is a role model for the organization
• Creative, hard-working, responsive, flexible, and willingness to adjust and adopt in a landscape of constantly changing program outcomes and priorities
• Ensures department staff are adequately trained
• Provides feedback through coaching and effective performance appraisal and development planning
• Contributes to the overall operation of the department including resource and budget planning
• Initiates and encourages scientific collaboration with groups outside the department

DECISION MAKING & JUDGMENT

• Anticipates, proactively detects, and addresses problems related to departmental and inter departmental activities
• Informs and consults management and senior staff appropriately

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
• Understands and applies 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
• Collaborate as well as lead others
• Apply creative thinking to problem solving and research
• Problem-solving skills, including application of scientific theory
• Knowledge of essential office and scientific software
• Knowledge of pharmaceutical and analytical chemistry
• Knowledge of chemical process development of drug product
• Knowledge of GLP, clinical and commercial manufacturing
• Experience with regulatory requirements for API/Product (CMC for IND/NDA, GLP/GMP, ICH)
• Experience with drug product pre-formulation, formulation, drug product development, scale-up and manufacture
• Experience with 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.