Join Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since ****, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year.As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Executive Director, Drug Substance Process DevelopmentWhat you will doLet's do this. Let's change the world. In this vital role, you are responsible for scientific and technical leadership of Drug Substance (DS) manufacturing processes and Attribute Sciences functions at Amgen's Puerto Rico site.Oversight responsibilities span commercialization through full scale process validation and life-cycle management of processes and methods for Amgen's mammalian and microbial DS manufacturing facilities in Puerto Rico.This executive leader role will work in close collaboration with Manufacturing, Engineering, Finance, Supply Chain and Quality functions to enable progressive improvements in commercial processes and analytical methods.You will have direct strategic responsibility for leading a team of 80+ scientists/engineers to support a growing portfolio with increased volumes. This position reports to the Vice President of Drug Substance Manufacturing, Amgen Manufacturing Limited (AML) and has a dotted line reporting to Vice President of Drug Substance Technologies, Process Development.ResponsibilitiesDrug substance technology and analytical method transfer to and from the siteProcess validation at scale across the two DS manufacturing plantsDrug substance and Attribute science CMC authoring activities for products, the latter in partnership with Attribute SciencesProcess monitoring activities, including real time multi-variate statistical process monitoringLife cycle improvements in commercial process, including improvements to increase yields and reduce cost of goods manufacturedEnsure manufacturing operations are aligned with the registered processProvide oversight and support for technical investigationsSafety and compliance of process development activitiesDeveloping strategy, setting goals and priorities, allocating resources, monitoring project progress, and managing the organization's budgetWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients!The Executive we seek is a strategic and collaborative leader with these qualifications.Basic Qualifications:Doctorate degree and 6 years of Scientific, Process Development and/or Technical Service experienceOrMaster's degree and 10 years of Scientific, Process Development and/or Technical Service experienceOrBachelor's degree and 12 years of Scientific, Process Development and/or Technical Service experienceIn addition to meeting at least one of the above requirements, you must have at least 6 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.Preferred Qualifications:PhD with 15+ years technical experience or a MS with 20+ years of technical experience in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline and 10+ years of managerial experience in a cGMP environment.Practical knowledge of the technologies related to analytical technologies, mammalian and microbial cell culture, protein purification, automation, validation and process engineeringStrong technical communication skills, both written and verbal, to interact effectively with all stakeholdersExperience in authoring marketing authorization applicationsWell-recognized in the scientific community through a record of peer-reviewed publications and/or patentsDemonstrated success developing staff, including effective feedback and coachingDemonstrated collaborative experience and ability to effectively work through othersBusiness acumen with track record of innovation and continuous improvement that provided strong financial benefitsWhat you can expect of usAs 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 a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insuranceA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.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.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
