This is your opportunity to join the Process Science team within Althea’s Biologics Manufacturing Group (BMG).
Candidate must be highly motivated and a strong team player.
As an Associate Engineer, you will be responsible for working within the framework of a team and performing the following activities: Develop and update engineering documents such as manufacturing instructions, drawings and test procedures Write/execute test protocols and reports, conduct various testing, and collect and analyze data/trends.
Essential Duties and Responsibilities include the following.
Conduct product testing, including complaint and stability samples.
Monitor enrollment activity and inventory levels and provide feedback to Supply Chain project lead regarding expiry and re-supply.
Assist with clinical label development and oversight of clinical product distribution.Take ownership of analytical method development for complex protein biomolecules (including E.coli, yeast, CHO derived proteins/antibodies and ADC) and related impurities conducting the preliminary qualification of these test methods for protein therapeutic candidates in pre-clinical and early-phase clinical development.Review and evaluate non-conforming materials, address customer experience reports, perform root cause analysis, and propose corrective/preventive actions.Perform engineering evaluations, process capability studies, time studies, capacity and cost analysis.Troubleshoot automated equipment for pharmaceutical formulation and packaging.