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.Senior Associate - Pivotal Drug ProductLiveWhat you will doLet’s do this! Let’s change the world! In this vital role you will develop, characterize and support the commercialization of the drug product manufacturing processes for all late-stage programs across the Amgen portfolio.You will work as part of Amgen's Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs) and fusion proteins). The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s drug product commercialization and lifecycle management.Responsibilities include:
Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics.
Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
Actively use sophisticated IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
Create visualizations to enable business application of data analysis.
Explore and evaluate new digital tools and techniques to improve the team’s developmental and operational capabilities.
As needed, provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
Support standardization and optimization of departmental practices by contributing to guideline documents.
Participate in global cross-functional teams working effectively in a highly matrixed team environment to progress product development.
Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an effective problem solver with these qualifications.Basic Qualifications:
Master’s degree OR
Bachelor’s degree and 2 years of Scientific and/or Process Development experience OR
Associate’s degree and 4 years of Scientific and/or Process Development experience OR
High school diploma / GED and 6 years of Scientific and/or Process Development experience
Preferred Qualifications:
Master’s degree in Chemical Engineering Chemistry, Biochemistry, Pharmaceutics, Biotechnology, Bioengineering, Material Science or related discipline.
2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments.
Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down models, characterization, and scale up.
Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality.
Proficiency in at least one statistical software package (such as SIMCA or JMP).
Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function.
Strong problem solving and effective cross-functional communication skills.
Proven ability to learn and act on dynamic information at a rapid pace.
ThriveWhat you can expect of usAs 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen 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.