Associate Director-Product Champion

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POST DATE 9/10/2016
END DATE 10/23/2016

AstraZeneca Pharmaceuticals LP Gaithersburg, MD

Gaithersburg, MD
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


Position Summary: br The Product Champion has a commercial biologics product focus and serves as the technical lead within operations for the assigned commercial product(s) throughout the commercial lifecycle. Major activities include oversight of process capability (through data trending and statistical analysis) to ensure processes are in a continued state of validation and continuously improving, Life Cycle Management and Regulatory support of post approval filings. In addition for products manufactured at CMO's the role also supports site MS&T activities (e.g. change control and deviation support). br br In addition to support of commercial projects the role may also serve as the operations representative on assigned pipeline product(s) on the Product Development Team (PDT) and CMC Team: serving as the champion of the product within operations to ensure alignment and drive pipeline progression as well as provide strategic and technical guidance and input to development to enable successful future commercial manufacture. br br Position: br Essential Job Functions: br For Commercial Products br * Maintain the oversight of the process for the product(s) assigned from drug substance raw materials through drug product primary packaging by: br o Ensuring that CPV parameters from production , QC, control systems, etc. are prospectively tracked br o Ensuring that all critical variables are tracked as appropriate for the assigned product(s) (Critical Process Parameters CPP, Critical Quality Attributes CQA, Critical In Process Control parameters CIPC, Critical Material Attributes CMA,etc) using statistical analysis and conducting regular product specific data trending br o Performing Continued Process Verification (CPV), data trending and statistical analysis (where applicable) br o Issuing quarterly/annual data trending report and support APQRs br * Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle br * Assess the product impact of manufacturing changes br * Provide MS&T (Manufacturing, Science & Technology) knowhow to deviations, investigations, OOE's and OOS's, technical complaints br * Identify process optimization opportunities and ensure execution at 3rd party manufacturer br * Ensure product manufacturing remediations and product validations are conducted and executed in line with Medi/AZ quality standards br * For Pipeline Products br * Serve as an empowered Operations representative on the PDT, working collaboratively and cross-functionally with other PDT members contributing to product vision, strategy, plans & delivery -- must consult with functional leaders and bring Operations view to the table to support PDT decision-making and planning br * Develops long term commercial manufacturing strategies in conjunction with Operations representatives and Development CMC teams to ensure delivery of clinical and commercial product that is consistent with Operations long range strategy and PDT product commercialization strategies. br * Responsible to align Development and Operations technical decisions necessary through completion of Process Validation to ensure the commercial viability of the manufacturing process. br * Partner with Regulatory and CMC teams to support the technical content of filings and ensure flexibilities are built in to minimize impact of future process changes.