Job Abstract

EMPLOYER:  AstraZeneca Pharmaceuticals LP

TITLE:  Product Technical Manager

LOCATION:  Gaithersburg, MD

HOURS:  Full-Time; Mon-Fri (40 hours/week)

DUTIES:  Drive implementation of and improvements to standard work and business processes across commercial CMC teams for the Biologics portfolio. Closely collaborate with Product Champions and CMC project managers to ensure all required standard work is executed in commercial CMC teams. Maintain the oversight of the process for the products assigned from drug substance raw materials through drug product primary packaging by ensuring all critical variables are tracked as appropriate for the assigned products. Oversee and drive uplift of digital capabilities within Global Technical Operations with a focus on improving access to and analysis of process data from external manufacturing partners as well as product knowledge management initiatives. Management of Lifecycle and Post Approval Changes through development of strategy and implementation plans for global post-approval changes. Work with CMC Project managers to develop detailed implementation timelines and work with CMC team and internal and external stakeholders to ensure implementation to plan while assessing the product impact of manufacturing changes.

REQUIREMENTS:  Must possess a Bachelor’s degree, or foreign equivalent, in Biology, Biomedical Engineering, or a related field, and 7 years of progressively responsible experience in the job offered, as a Biomedical Engineer or related role. In the alternative, employer will accept a Master’s degree, or foreign equivalent, in an above stated field of study and 5 years of experience. Must possess 7 (or 5 with a Master’s) years of experience with all of the following: Utilizing experience in pre-commercial and commercial Biologics development and manufacturing; Leading manufacturing data reviews for Biologics processes performed at a Contract Manufacturing Organization (CMO); Designing analysis methods and visualizations for Biologics processing data using an industry standard Biologics-focused visualization software platform; Interfacing with Biologics Contract Manufacturing Organizations (CMOs) and raw material vendors to drive improved process/raw material performance; Developing novel technologies to drive improvement and gain understanding of existing Biologics processes; Generating data to assess potential impact of implementation and analyzing data results to support go/no-go decision on implementation; Developing visualization solutions for Biologics manufacturing data, including management of database solutions on the Microsoft platform.

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