Process Development Senior Scientist Analytical Chemist

1 month ago

Newbury Park, California, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Process Development Senior Scientist – Analytical ChemistLive

What you will do

Lets do this Lets change the world

Amgen is currently seeking a Sr. Scientist Analytical Chemist in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.

The Scientist will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic small molecule, synthetic peptide, and/or siRNA programs. The Scientist will integrate and optimally apply platform and in–depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.Key Responsibilities: Define analytical control strategies and implement methodologies for development of late phase clinical programs. Develop, optimize, and authorize analytical methods for synthetic small molecules, and/or synthetic peptide testing and characterization. Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives. Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry. Lead activities at contract manufacturing and testing sites. May lead method transfer to CMO or contract testing labs. Review and approve protocols, reports from CMO and contract testing labs. Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. May lead and mentor a small group of scientists. WinWhat we expect you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree PhD OR PharmD OR MD and relevant post–doc where applicable OR Masters degree and 3 years of scientific experience OR Bachelors degree and 5 years of scientific experience Preferred Qualifications: PhD in Analytical Chemistry, Biochemistry with emphasis in mass spectrometry 2+ years post–PhD experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products. Advanced and proficient understanding and use of technical principles, theories, and concepts to perform an expansive range of work for the role. Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry. Hands on experience in method development, validation, and transfer for in–process, release, and stability testing Experience in peptide method development, characterization, and analytical control strategy, especially having mass spectroscopy (MS) experience. Proficiency in a broad spectrum of structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR, etc. Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc. Excellent communication skills and ability to provide cross–functional leadership and guidance to CMC and non–clinical teams, e.g. informing and defending the Quality Target Product Profile Ability to work effectively in cross–functional teams, and across various geographic locations in different time zones. Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents ThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well–being. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales–based incentive plan Stock–based long–term incentives Award–winning time–off plans and bi–annual company–wide shutdowns Flexible work models, including remote work arrangements, where possible Apply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. 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 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 accommodation.

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