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Director Process Development: Pivotal Drug Substance

Company: Amgen Inc. (IR)
Location: Cambridge
Posted on: February 17, 2021

Job Description:

Director Process Development: Pivotal Drug Substance US - Massachusetts - Cambridge Career CategoryProcess DevelopmentJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and deliverin g ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.-- Director, Process Development: Pivotal Drug Substance Cambridge, MA Live What you will do Let's do this. Let's change the world. In this vital role, you will lead with an entrepreneurial approach and ambition to dr ive innovation and develop efficiency through exploration of process, technology and capacity improvement opportunities.-- The Director confirms the group's outputs are safe, compliant, and aligned with Pivotal drug substance goals. This leader develops a team within Pivotal Drug Substance who are responsible for the late stage development of biologics programs as well as advancing technology development. The programs represent a wide range of biologics molecules including mAbs , BiTEs , biosimilars, bispecifics , and other novel modalities.-- A s the primary process development point of contact with key leadership partners in Manufacturing and Quality , you will ensure that drug substance process development deliverables including: 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.-- Responsibilities

  • Lead diverse high performing multi-functional drug substance team that is comprised of an integrated cell culture and purification disciplines located in both Cambridge, MA and Thousand Oaks, CA .
  • Develop staff and manage portfolio resourcing .
  • Advance integrated holistic drug substance processes for Amgen's 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 .
  • Author global filings including IND/ INDa /MA and responding to Regulatory questions.
  • Ideation, development, and deployment of differentiating technologies and establishing a culture of innovation.
  • Contribute to Amgen's 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. Wo rk 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. Win What we expect of you Basic Qualifications: Doctorate degree and 4 years of Scientific, Process Development and/or Technical Services experience OR Master's degree and 8 years of Scientific, Process Development and/or Technical Services experience OR Bachelor's degree and 10 years of Scientific, Process Development and/or Technical Services experience AND 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 Engineering
    • 10+ years of experience in biopharmaceutical process development and global regulatory expectations
    • Demonstrated ability 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 of Late Stage process 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
    • Established success developing staff, including effective feedback and coaching or mentoring
    • Exemplify collaborative experience and ability to effectively work through others--- Thrive 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 Apply now 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. . Posted 5 Days Ago Full time R-112284 About Us Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Keywords: Amgen Inc. (IR), Cambridge , Director Process Development: Pivotal Drug Substance, Executive , Cambridge, Massachusetts

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