Director Process Development: Pivotal Drug Substance
HOW MIGHT YOU DEFY IMAGINATION?
If you feel likeyourepart of something bigger, its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing and delivering ever-better products that reachover 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Director,Process Development: Pivotal Drug Substance
What you will do
Lets do this. Lets change the world.In this vital role, you will lead with anentrepreneurial approachandambition to drive innovation and developefficiency through exploration of process, technology and capacity improvement opportunities.The Directorconfirms thegroups outputs are safe, compliant, and aligned with Pivotal drug substance goals.
This leaderdevelopsa team within Pivotal Drug Substancewho areresponsible for thelate stagedevelopment of biologics programs as well as advancing technology development.The programs represent a wide range of biologics molecules includingmAbs,BiTEs, biosimilars,bispecifics, and other novel modalities.As the primary process development point of contact with key leadership partners in Manufacturing and Quality, youwill ensure that drug substance process development deliverablesincluding:commercial process development and process characterization; development and implementation of new technologies; process control strategy for Process Performance Qualification (PPQ); regulatory filing and response to questions are managed and executed.
Lead diverse high performing multi-functional drug substance team that is comprised of an integrated cell culture and purification disciplineslocated in both Cambridge, MA and Thousand Oaks, CA.
Develop staff and manage portfolio resourcing.
Advanceintegrated holistic drug substance processes for Amgens multi-modal portfolio (mAbs,BiTEs,bispecifics, and biosimilars) for late stage clinical and commercial implementation. This includes commercial process development, process characterization, lifecycle management, development of control strategies as well as supporting transfer of process to internal and external manufacturing network.
Authorglobal filings including IND/INDa/MA and responding to Regulatory questions.
Ideation, development, and deployment of differentiating technologies and establishing a culture of innovation.
Contributeto Amgens external eminence at scientific and regulatory conferences and other industry forums.
Serve as member of Drug Substance Technology extended leadership team and advancing the process development function. Workin partnership with management to develop plans that support thedirections of the business, plans implementation of major change efforts and contributes to organization thought leadership.
What we expect of you
Doctorate degree and 4 years ofScientific, Process Development and/or Technical Servicesexperience
Masters degree and 8 years ofScientific, Process Development and/or Technical Servicesexperience
Bachelors degree and 10 years ofScientific, Process Development and/or Technical Servicesexperience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
We are all different, yet we all use our unique contributions to serve patients. The top tierProject Controlsprofessional we seek is experienced with these qualifications:
PhD degree in Biochemistry, Biochemical or ChemicalEngineering
10+ years of experience in biopharmaceutical process development and global regulatory expectations
Demonstratedability in providing scientific and engineering expertise to multi-functional teams in Process Development, Manufacturing, Quality and Supply Chain to advance complex projects to completion and to interface on technical problem resolution
Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to cross-functional audience and senior management
Detailed understanding of all stages ofLate Stageprocess development for biologics: commercial process development, process characterization, process design,Process Performance Qualification (PPQ), regulatory filing and response
Experience in authoring marketing authorization applications
Strong technical communication skills, both written and verbal, to interact effectively with all stakeholders
Practical knowledge of the technologies related to mammalian cell culture, purification, automation, and validation
Active participation in the scientific community through a record of peer-reviewed publications and/or patents, as well as active participation in industry forums and/or conferences
Establishedsuccess developing staff, including effective feedback and coaching or mentoring
Exemplifycollaborative experience and ability to effectively work through others
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a 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 an accommodation.
Join UsIf 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.