Career CategoryOperations
Job DescriptionProcess Development Associate ScientistWhat you will doLet'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 youWe 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 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.comApplication 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.
