Process Development Sr Principal Scientist

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

Basic Qualifications:

Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience OR Master’s degree and 5 years of Scientific experience OR Bachelor’s degree and 7 years of Scientific experience

Preferred Qualifications:

PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.

Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for small molecule, peptide, and/or oligonucleotide drug substances and products.

Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.

Strong understanding of peptide and/or oligonucleotide structural elucidation and characteristics that relate to quality of peptide and/or oligonucleotide.

Hands on experience in method development, validation, and transfer for in-process, release, and stability testing

Strong experience in oligonucleotide 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.

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 concise summary to 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

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.