Process Development Scientist
6 days ago
HOW MIGHT YOU DEFY IMAGINATION?
You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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 Scientist - Analytical Chemist
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you 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 utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.
Develop strategies and implement methodologies for process development of late phase synthetic clinical programs.
Develop, optimize, and authorize analytical methods for synthetic small molecules, synthetic peptide, and/or SiRNA release 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.
Win
What we expect of 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:
Bachelor’s degree and 4 years of Scientific experience; OR
Master’s degree and 2 years of Scientific experience; OR
Doctorate degree
Preferred Qualifications:
MS or PhD in Analytical Chemistry, Organic Chemistry, Biochemistry, Material Sciences or equivalent.
Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products.
Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.
Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
Experience in analytical method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
Experience in fundamental programming skills (such as Python, MATLAB, etc.) is preferred.
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.
Solid understanding of GLP and 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, able to manage deliverables against timelines.
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
Thrive
What 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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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 now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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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