Associate Scientist, Process Development; Process Validation & Business Strategy

Associate Scientist, Process Development (Process Validation & Business Strategy)

Join the application for the Associate Scientist, Process Development (Process Validation & Business Strategy) role at Bio Space
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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 lie within them, you’ll thrive as part of the Amgen team.

Join us and transform the lives of patients while transforming your career.

Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best‑in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon‑neutral company by 2027.

In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen’s FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. The role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes process development operation support, developing digital tools to support business processes, and supporting commercial development of Amgen’s pipeline.

• Lead and develop the Process Development safety, training, and compliance monitoring operation.
• Serve as the Holistic Lab Execution Environment (HLEE) champion for the process development lab.
• Develop digital tools to improve business process efficiencies and identify bottlenecks within the process development operation.
• Develop digital tools to support process validation and process monitoring activities.
• Support and develop the Amgen North Carolina (ANC) PD DST knowledge‑management ecosystem, align ANC PD business process to network practice, and optimize the ANC PD business process.
• Provide process floor or lab support as required.

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

• Bachelor’s degree and 3 years of Process Development or Scientific experience OR
• Master’s degree and 1 year of Process Development or Scientific experience.

• 2–4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role.
• Knowledge of broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes.
• Familiarity with operational aspects of process development lab or commercial biopharma manufacturing.
• Experience with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS Power
  
  BI, Spotfire, and/or Databricks.
• Able to apply digital tool skills to solve business process issues and evaluate opportunities for process improvements.
• Excellent written and verbal communication.
• Self‑starter with the ability to take on several projects at one time.

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…