As Director, Process Development, you will report to the Executive Director, Process Development and:
Report dotted line to DST leadership, leading a team at AIN that is focused on advancing drug substance deliverables for all Amgen products
Work with functional partners within AIN as well as other Amgen sites and teams to define roles and responsibilities, hire and build new teams and implement new processes
Build and lead a new DST team at AIN with capabilities across technical documentation, regulatory authoring and support, data analytics, automation/digital tools, and process monitoring
Creation of strong communication channels with existing DST teams across the Amgen sites to establish and drive knowledge sharing, learning and networking
Work with cross-functional teams to establish and improve digital tools as voice of customer
Manage the team for Drug Substance Technologies at AIN to ensure timely completion of goals and objectives
Set project timelines and priorities for key initiatives and/or team activities
Lead and develop the team, providing staff member supervision and on-going coaching
Strategically plan, analyze, and manage resources to include budget, contractors, staff, etc.
Act upon performance metrics and process issues, implementing actions to drive continuous improvement and escalation to management if needed
Partner to establish the operating model, governance, and engagement framework for the AIN DST team in partnership with DST leadership and AIN site stakeholders
Translate business, technical, and regulatory needs into team capabilities, priorities, and execution plans
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications
Doctorate degree and 8 years of drug substance biotech experience OR
Master’s degree and 15 years of drug substance biotech experience OR
Bachelor’s degree and 20 years of drug substance biotech experience AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
14+ years of drug substance process development or manufacturing experience in biotech or pharmaceutical industry
Advanced Degree in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline
Knowledge of cGMP regulations (FDA, EMEA, Health Canada)
Working knowledge of applicable drug substance manufacturing/ testing processes (process development, process validation, commercial manufacturing)
Experience applying automation, artificial intelligence, machine learning, or large language model-enabled tools in a compliant enterprise environment.
Knowledge of statistics, data analytics tools and methods
Knowledge of project management tools and Agile methodologies
Strong leadership skills with the ability to build new teams and implement new processes
Demonstrated ability leading and coaching cross-functional teams, consistently deliver on-time, and with high-quality results
Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership, including communicating level of risk, urgency, or impact to the business
Ability to operate in an international matrix or team environment with site, functional, and executive leadership
Ability to flex working hours to maximize interactions with global teams
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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