Process Development Senior Scientist (Analytical Chemist)
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.
Process Development Senior Scientist - Attribute Sciences Analytical Chemist
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 Pre-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. This role primarily focuses on synthetic modalities.Live
What you will do
Lets do this. Lets change the world. In this vital role you will work to provide strategic analytical leadership (as an Attribute Sciences team lead and group lead) to teams developing first in human manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.Role 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)
Act as an Attribute Sciences Team lead for a program in Pre-Pivotal clinical process development responsible for all analytical work to support the program
Define the analytical target profile (ATP) for methods used to supervise product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
Manage activities at contract manufacturing and testing sites
Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications.Basic Qualifications:
Doctorate degree and 2 years of life sciences industry experience
Masters degree and 5 years of life sciences industry experience
Bachelors degree and 7 years of life sciences industry experiencePreferred Qualifications:
Strong understanding of small molecule analysis including spectroscopic techniques with an emphasis toward process understanding and process control, separation science, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry
Understanding of analytical method development toward solid oral dosage support, including dissolution method development
Solid understanding 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, qualify, 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
Good 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 great teammate 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
Some of the vast rewards of working here
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.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
#Operations21Equal 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.