Process Development Sr Associate

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybride; USD 91 000 - 108 000; Plein temps

Avantages offerts par ce poste

Stock options

Retirement plan

Health insurance

Life and disability insurance

Annual bonus

Résumé du poste

Amgen is seeking a Process Development Associate to lead method development for analytical characterization. You will perform HPLC/UHPLC/CE and LC-MS studies, document results, and support method transfer to QC in a GMP setting.

The role requires a chemistry-based degree and 2 years of hands-on experience with analytical methods, data analysis, and GLP compliance. A hybrid work model and comprehensive benefits are included.

Qualifications

• Bachelor’s degree in Chemistry, Chemical Biology or related field.
• 2 years of experience in analytical chemistry or related role.
• Experience with LC/LC-MS, HPLC, CE and related techniques.
• Experience with method development, qualification and transfer of analytical methods.
• Familiarity with GLP and data documentation.

Responsabilités

• Develop and qualify LC methods (HPLC/UHPLC/CE) for product characterization.
• Perform LC-MS studies and chromatographic fractionation to support studies.
• Document results in notebooks and method development reports; transfer methods to QC.
• Maintain instruments and support GMP-compliant environment.
• Coordinate stability studies and evaluate new platform technologies.

Connaissances

Analytical chemistry

LC/LC-MS

Method development

Data analysis

GLP knowledge

Formation

Bachelor’s degree in Chemistry or related field

Outils

Empower

Chromeleon

ChemStation

Description du poste

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. 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

Duties: Perform method development and qualification studies using High Performance Liquid Chromatography (HPLC), Ultra-High Performance Liquid Chromatography (UHPLC), and Capillary Electrophoresis (CE) platforms; Perform chromatographic fractionation, peptide mapping, intact mass, and other Liquid Chromatography - Mass Spectrometry (LC-MS) studies to support product characterization and comparability studies; Author results in laboratory notebooks and method development reports, interfacing closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods; Participate in the maintenance of Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase-appropriate good manufacturing practices (GMP) environment; Focus toward evaluation of critical quality attributes, coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions; Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways; Perform evaluation of novel platform analytical technologies to help drive innovation; and Perform experiments to help answer questions from health authorities; and Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.

Requirements: Bachelor’s degree (or foreign equivalent) in Chemistry, Chemical Biology or related field & 2 years of experience in the job offered or a research-related occupation. Position requires 2 years of experience in the following:

• Analytical chemistry experience for protein molecules, and completion of project deliverables including: designing and conducting degradation experiments, extracting and analyzing results via dedicated software: Empower, Chromeleon, and ChemStation;
• Liquid Chromatography principles, including the concepts of stationary and mobile phases, partitioning and separation based on different affinities;
• Analytical method development (chromatography and mass spectrometry), technologies and instrumentation including: High Performance Liquid Chromatography (HPLC), Liquid Chromatography - Mass Spectrometry (LC-MS), Solo Variable Pathlength Extension (SoloVPE), and Capillary Electrophoresis (CE);
• Method qualification and transfer for analytical instruments, along with data analysis and statistical evaluation of experimental results;
• Application analytical instrument troubleshooting across different platforms: Waters, Agilent, and Maurice;
• Analytical deliverables for pharmaceutical processes and product development;
• Data analysis, statistical analysis and method qualifications and transfers;
• Technical knowledge of proteins and peptides;
• Implementing Standard Operating Procedures in a laboratory environment in accordance with good laboratory practices (GLP) standards; and
• Recording experimental conditions, results and observations in a laboratory notebook.

Job type: Full-Time position. The annual salary range for this position in the U.S. is $91,125.00 - $108,296.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/

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, including remote and hybrid work arrangements, where possible

careers.amgen.com

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.

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.