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

Amgen

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. 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. Associate Scientist, Process Development (Process Validation & Business Strategy) What you will do Let’s do this. Let’s change the world. 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. This 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 support commercial development of Amgen’s pipeline. The role will be responsible for ensuring PD business strategy operations have appropriate digital tools to track operational metrics for safety, training, compliance, support business processes improvements, and the commercial development of the Amgen’s pipeline. In addition, the role will be responsible for supporting tech transfer activities as needed.

Requirements

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

Nice To Haves

2 – 4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role.
Knowledge in broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes
Familiarity in operational aspects of process development lab or commercial biopharma manufacturing
Experienced with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS PowerBI, 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
Be a self-starter with the ability to take on several projects at one time.

Responsibilities

Lead and develop the Process Development safety, training, and compliance monitoring operation
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, alignment of ANC PD business process to network practice, and optimizing the ANC PD business process.
Provide process floor or lab support as required

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