HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part 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 reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Director, Process Development: Pre-Pivotal Drug Substance TechnologiesLive
What you will do
Lets do this. Lets change the world. In this vital role, you will lead with an entrepreneurial approach and ambition to drive innovation and develop efficiency through exploration of process and technology to advance Amgens exciting early stage pipeline. The Director confirms the groups outputs are safe, compliant, and aligned with organizational goals.
This leader develops a team within Pre-Pivotal Drug Substance who are responsible for the development and advancement of a large and diverse portfolio of Biologic therapeutic molecules from Research to IND and enables GMP supply for early clinical trials. The programs represent a wide range of biologics molecules including mAbs, BiTEs, bispecifics, conjugates, and other novel modalities. As the primary point of contact with key leadership partners in Research, Process Development and Clinical Manufacturing you will be responsible for the delivery of data packages to support therapeutic candidate selection as well as the development and tech transfer of drug substance processes for clinical manufacturing. You will ensure the successful drug substance process development deliverables including molecule and developability assessments, final clone selection, upstream and downstream process development, process characterization and tech transfer for clinical manufacturing, development. In addition, you will drive implementation of new technologies, including automation, predictive modeling, new manufacturing technologies, process intensification, viral clearance; and ensure regulatory filing and response to questions are managed and executed with quality and rigor.Responsibilities
- Lead diverse high performing multi-functional drug substance team of 20+ staff that is comprised of an integrated cell culture and purification disciplines located Thousand Oaks, CA.
- Develop staff and manage portfolio resourcing.
- Advance integrated holistic drug substance processes for Amgens multi-modal portfolio (mAbs, BiTEs, bispecifics, conjugates) for pre-clinical and clinical development. This includes molecule assessment, early process development and process characterization activities, as well as supporting transfer of processes to internal and external manufacturing networks.
- Author IND filings and respond to global Regulatory questions.
- Ideation, development, and deployment of differentiating technologies and establishing a culture of innovation.
- Contribute to 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. Work in partnership with management to develop plans that support the directions of the business, plans implementation of major change efforts and contributes to organization thought leadership.
What we expect of youBasic Qualifications:
Doctorate degree and 4 years of Scientific, Process Development and/or Technical Services experience
Masters degree and 8 years of Scientific, Process Development and/or Technical Services experience
Bachelors degree and 10 years of Scientific, Process Development and/or Technical Services experience
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 tier Project Controls professional we seek is experienced with these qualifications:PhD degree in Biochemistry, Biochemical or Chemical Engineering10+ years of experience in biopharmaceutical process development and global regulatory expectationsDemonstrated ability in providing scientific and engineering expertise to multi-functional teams in Process Development, Research, Manufacturing, Quality and Supply Chain to advance complex projects to completion and to interface on technical problem resolutionAbility to compile and statistically analyze data, draw appropriate conclusions and make presentations to cross-functional audience and senior managementDetailed understanding of all stages of drug substance process development for biologics: clinical and commercial process development, process characterization, process design, regulatory filing and responseExperience in authoring marketing authorization applicationsStrong technical communication skills, both written and verbal, to interact effectively with all stakeholdersPractical knowledge of the technologies related to mammalian cell culture, purification, automation, and validationActive 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 conferencesEstablished success developing staff, including effective feedback and coaching or mentoringExemplify collaborative experience and ability to effectively work through othersThrive
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.
careers.amgen.comEqual 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.