Process Development Sr Scientist

We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree OR Master’s degree and 2 years of directly related life science experience OR Bachelor’s degree and 4 years of directly related life science experience OR Associate’s degree and 8 years of directly related life science experience OR High school diploma / GED and 10 years of directly related life science experience

Preferred Qualifications:

Doctorate degree with 5-7+ years in Analytical Chemistry, Biochemistry or equivalent.

Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.

Strong background in analytical method development of biologics such as monoclonal antibodies and multispecifics.

Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF

Demonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings.

Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools

Strong problem solving and effective multi-functional interpersonal skills.

Ability to develop, validate, transfer and remediate methods for in-process, release and stability testing

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

Strong 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 team player with strong leadership and decision-making skill

As 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.

In 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.

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.

Sponsorship for this role is not guaranteed.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.