Process Development Senior Scientist

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.

Process DevelopmentSeniorScientist:Attribute Sciences

Live

What you will do

Lets do this. Lets change the world. Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines, monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), and live oncolytic viruses.

In this vital role you will work to provide strategic analytical leadership (as an Attribute Sciences team lead and group lead) to teams developingcommercialized manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.

Responsibilities:

• Lead a team that provides analytical data to support Drug Substance and Drug Product development, including purity analysis, chiral purity, dissolution analysis, and structural elucidation using mass spectrometry, Fourier Transform Infrared (FTIR), and Nuclear Magnetic Resonance (NMR)
• Work in a laboratory setting providing analytical support and expertise structure elucidation of mixtures containing organic and inorganic materials
• Design and execute experiments using various analytical instruments such as liquid chromatography mass spectrometry (LC/MS), gas chromatography mass spectrometry (GC/MS), high performance liquid chromatography (HPLC), inductively coupled plasma mass spectrometry (ICP/MS) and nuclear magnetic resonance (NMR)
• Manage projects, provide regular updates, write protocols and technical reports, and/or communicating program results
• Collaborate with other scientists and keep current with both the literature and technology associated with the field of expertise
• Additional opportunities may involve advising supervisors and colleagues in areas of expertise
• Providing scientific results that support the generation of publications, patents or regulatory submissions and supervising research associates and assistants
• Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
• Provide expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development
• Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
• Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities and applies this knowledge to the evaluation and development of new methodologies
• Recognized as a scientific resource in area of expertise

Win

What we expect of you

Basic Qualifications:

• Doctorate degree and 2 years of experience OR
• Masters degree and 6 years of experience OR
• Bachelors degree and 8 years of experience

Weare all different, yet we all use our unique contributions to serve patients. The scientific professional we seek has these qualifications:

• Strong understanding of small molecule analysis including spectroscopic techniques with an emphasis toward Process Analytical Technologies (PAT) for process understanding and process control, separation science, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry. Solid understanding of analytical method development toward solid oral dosage support, including dissolution method development
• Working knowledge of large molecule analysis
• Experience in a wide variety of analytical and physicochemical techniques including chromatography (High- Performance Liquid Chromatography: HPLC, Gas Chromatography: GC, Capillary Electrophoresis: CE), mass spectrometry, Ultraviolet: UV, Nuclear Magnetic Resonance: NMR, Fourier Transform Infrared: FTIR, Raman, particle size determination, crystal characterization, dissolution, etc.
• Ability to develop, validate, transfer and remediate methods for in-process, release and stability testing
• Experience in analytical testing requirements for immediate release and controlled release solid dosage forms, liquid formulation or lyophilized formulation
• Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development, etc.
• Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner
• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, managing deliverables against timelines
• Strong communication skills and ability to provide cross-functional leadership and guidance to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams,e.g.informing and defending the Quality Target Product Profile
• Works well in cross-functional teams, and across various geographic locations in different time zones
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
• Experience with protein-based and live modality therapies is beneficial (monoclonal antibodies, bi/tri-specific antibodies, fusion proteins, gene therapy, etc.)
• A self-starter and team player with strong leadership and decision-making skills, who can provide mentorship to junior staff
• Ability to multitask, effectively plan and follow through on complex projects
• Someone who strongly values working on and leading teams

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

Objects in your future are closer than they appear. Join us.

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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 Us

If 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.