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What you will do
Lets do this. Lets change the this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgens 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 Amgens 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 Amgens addition the role will be responsible for supporting tech transfer activities as needed.
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
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications.
Additional Qualifications/ResponsibilitiesBasic Qualifications:
Bachelors degree and 3 years of Process Development or Scientific experience OR
Masters degree and 1 years of Process Development or Scientific experience
Preferred Qualifications:
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.
Salary Range
97377.00 USD - 118653.00 USD