Process Development Scientist

Amgen Inc. • Thousand Oaks, CA

65d

About The Position

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 Scientist (Attribute Sciences) What you will do Let's do this! Let's change the world! This role is part of Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization. The Process Development Scientist will broadly support microanalytical investigations by generating and analyzing data, and reporting out results of experiments designed to identify and assess unknown or unexpected materials (e.g., organic, inorganic, and/or biological in origin) observed during commercial or clinical manufacturing and/or development activities. The Scientist will collaborate with internal and external partners across a global manufacturing and PD network to aid in determining root cause and corrective actions for the unexpected observations. The Scientist will need to understand and apply state-of-the-art spectroscopic and microscopic analytical tools to forensics investigations, applying a level of documentation and compliance rigor commensurate to the responsibility to ensure that Amgen's products and processes meet the highest current Good Manufacturing Practices (cGMP) quality standards. Additionally, the Scientist will support a chemo-metric spectroscopy-based analytical method platform. The Scientist will be involved in generating and analyzing data to ensure continuous monitoring, maintenance, and validation of the chemo-metric models that are used for testing in GMP manufacturing. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a motivated, self-starter with these qualifications.

Requirements

• Bachelor's degree and 4+ years of Scientific or Operations experience
• Master's degree and 2+ years of Scientific or Operations experience
• Doctorate degree

Nice To Haves

• Advanced degree in Physical Chemistry, Analytical Chemistry, Chemical Engineering, Materials Science or related scientific field
• In-depth expertise in vibrational spectroscopies such as Fourier-Transform Infrared and Raman
• Experience with microscopy (e.g., optical, scanning electron) and microanalytical techniques for characterization of materials
• Demonstrated ability to critically analyze analytical datasets to influence the investigational process
• Strong understanding and experience of wet chemistry and sample handling
• Understanding of multivariate analysis techniques, ideally including chemo-metric model training, validation, monitoring, and maintenance
• Strong commitment to compliance with Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP) standards
• Experience in an investigational laboratory setting within a pharmaceutical or biotechnology company
• Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment

Responsibilities

• support microanalytical investigations by generating and analyzing data, and reporting out results of experiments designed to identify and assess unknown or unexpected materials
• collaborate with internal and external partners across a global manufacturing and PD network to aid in determining root cause and corrective actions for the unexpected observations
• understand and apply state-of-the-art spectroscopic and microscopic analytical tools to forensics investigations, applying a level of documentation and compliance rigor commensurate to the responsibility to ensure that Amgen's products and processes meet the highest current Good Manufacturing Practices (cGMP) quality standards
• support a chemo-metric spectroscopy-based analytical method platform
• involved in generating and analyzing data to ensure continuous monitoring, maintenance, and validation of the chemo-metric models that are used for testing in GMP manufacturing

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees