Career CategoryOperations
Job DescriptionProcess Development Senior Scientist - Attribute SciencesWhat you will doLet's do this. Let's change the world.This is an exciting opportunity to join the Amgen Biologics Pivotal Attribute Sciences team based in Cambridge, Massachusetts. In this role you will:
- Develop, optimize, troubleshoot, qualify, validate, and transfer analytical methods for monitoring critical quality attributes and supporting process characterization, comparability assessments, investigations, and control-strategy development.
- Lead late-stage protein characterization, structural elucidation, and forced degradation studies using high-resolution LC/MS, including peptide mapping, disulfide mapping, and intact mass analysis.
- Establish robust, automation-ready analytical workflows encompassing sample preparation, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency.
- Interpret complex analytical data and author or review technical and regulatory documentation, including analytical methods, protocols, reports, and CMC sections for INDs and BLAs.
- Provide analytical subject-matter expertise and technical guidance to cross-functional partners.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leder with these qualifications.
Basic Qualifications:Doctorate degree
OR
Master's degree and 2 years of
Scientific experience
OR
Bachelor's degree and 4 years of
Scientific experience
Preferred Qualifications:- Three or more years of experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
- Deep expertise in analytical method development, as well as structural and physicochemical characterization of biologics, including monoclonal antibodies, fusion proteins, and protein conjugates such as antibody-drug conjugates.
- Deep LC/MS expertise in bottom-up peptide mapping (including disulfide mapping) and intact mass analysis for biologics, with strong fundamentals in sample preparation, artifact control, and MS/MS data interpretation.
- Hands-on experience with Thermo Orbitrap platforms, including routine maintenance, calibration, and independent troubleshooting of common failure modes. Experience with Chromeleon and Biopharma Finder is a plus.
- Hands-on experience with laboratory automation including liquid handlers, pipetting robots, and automation software.
- Experience in authoring and reviewing regulatory submissions, especially module 3 (Quality) common technical documents for IND/BLA submissions.
- Strong written and verbal communication skills, with the ability to translate complex data into clear recommendations for diverse internal and external stakeholders.
- A proactive self-starter with strong problem-solving and decision-making skills who works independently, prioritizes effectively, and manages multiple complex projects through completion.
What you can expect from usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
- A 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
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen 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.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range126,066.05USD -170,559.95 USD
