Process Development Associate Scientist

Amgen SA; Cambridge (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen is seeking an Process Development Associate Scientist to join a team developing analytical tools and methods for late-stage programs across small molecules, peptides, siRNA, and conjugates. You will integrate platform knowledge to advance Amgen products through pivotal clinical phases to regulatory submission.

Responsibilities include method development/validation, sample prep, data documentation, results presentation, and method transfer to CMOs.

Qualifications

• Experience developing and validating analytical methods for small molecules and peptides.
• Hands-on sample prep and analysis using chromatographic and spectroscopic techniques.
• Strong documentation using electronic laboratory notebook and GMP/GLP awareness.
• Ability to present results and support development programs.
• Experience transferring methods to contract manufacturing or testing labs.

Responsibilities

• Develop and validate analytical methods for synthetic molecules.
• Perform sample prep and analysis of in‑process and drug product samples.
• Organize and document data per Good Documentation Practice.
• Present results to support drug substance and product development.
• Transfer methods to contract manufacturing or testing labs.

Skills

Analytical method dev

Chromatography

Spectroscopy

Data analysis

Documentation

Technical writing

Problem solving

Communication skills

GLP/GMP knowledge

Drug development

Education

Master’s degree in Analytical Chemistry

Tools

Liquid chromatography

Gas chromatography

Mass spectrometry

Electronic lab notebook (ELN)

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Associate Scientist

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 programs across small molecules, synthetic peptides, siRNA, and synthetic components of conjugates. 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.

• Select suitable methodology and techniques to develop and validate analytical methods in consultation with supervisor for testing synthetic molecules, including small molecules, synthetic peptides, siRNA, and the synthetic components of antibody–drug conjugates for drug substances and/or drug products.
• Hand‑on experience in sample preparation and analysis of synthetic in‑process samples, lot release samples, and drug product formulations using primarily chromatographic and spectroscopic techniques.
• Organize and document analytical data under Good Documentation Practice using electronic laboratory notebook system.
• Provide and present results in consultation with supervisor to support drug substance and drug product development.
• Transfer analytical methods to contract manufacturing or contract testing labs.

What we expect of you

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:

• Select suitable methodology and techniques to develop and validate analytical methods in consultation with supervisor for testing synthetic molecules, including small molecules, synthetic peptides, siRNA, and the synthetic components of antibody–drug conjugates for drug substances and/or drug products.
• Hand‑on experience in sample preparation and analysis of synthetic in‑process samples, lot release samples, and drug product formulations using primarily chromatographic and spectroscopic techniques.
• Organize and document analytical data under Good Documentation Practice using electronic laboratory notebook system.
• Provide and present results in consultation with supervisor to support drug substance and drug product development.
• Transfer analytical methods to contract manufacturing or contract testing labs.
  

Preferred Qualifications:

• Master’s degree in Analytical Chemistry, Organic Chemistry, Physical, Pharmaceutical, Life Sciences or Engineering
• Strong experience in small molecule/ synthetic peptide analysis, including theoretical knowledge, research, and hands‑on experience to support process development/scale up activities and formulation development.
• Experience with operation, maintenance, and troubleshooting of laboratory equipment and instrumentation, especially chromatographic (e.g. liquid chromatography and gas chromatography) and spectroscopic instruments (e.g. mass spectrometry).
• Experience in laboratory settings within the pharmaceutical or biotech industry
• Technical aptitude for identification, development, and implementation of novel analytical technologies, such as mass spectrometry (MS), vibrational spectroscopy, or nuclear magnetic resonance (NMR) etc.
• Understanding of GLP and GMP requirements and their application in a phase appropriate manner
• Abilities in troubleshooting, problem solving, and multi-tasking in support of process chemistry and formulation efforts during the pivotal phase of development
• Strong written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast‑paced, multi‑disciplinary, team‑based environment
• Strong theoretical understanding, research in, and hands‑on experience in small molecule/peptide analysis in support of process development/scale up activities and formulation development in GMP and non‑GMP environments
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

What you can expect of us

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

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.