Prospanica 2016 Process Informatics Program Manager

Prospanica 2016 Process Informatics Program Manager
+ Requisition ID:141785
+ Position:
+ Open date:Aug 24, 2016 9:36 PM
+ Functional area:Engineering
+ Location:Maryland
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+ + Required degrees:Bachelors
+ Experience required:5 years
+ Relocation:No
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Basic qualifications:B.S. Engineering, Biotechnology, Applied Statistics or other relevant technical field.
Five years of experience, preferably in the biopharm setting in a manufacturing, quality or technical function
Preferred qualifications:Basic biopharm process knowledge (familiar with major unit operations, typical production records, chromatograms, and the typical data collected and reviewed).
Capable of applying basic statistical methods, for example hypothesis testing such as t-test, and statistical process control.
Familiarity with computerized systems such as Manufacturing control systems (DeltaV or similar), data historians, LIMS, SAP, etc.
Knowledge of DoE, multivariate analysis, process capability, Measurement Systems Analysis, Lean Manufacturing, Six Sigma and Statistical Process Control applications.
Experience with Statistica, SIMCA, JMP, R, Minitab, SAS or similar analysis software
Basic SQL query knowledge, basic programming such as VBA, or similar.
Details:Why GSK? Because GSK?s Biopharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK?s Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance ? Being accountable for quality and safety.
GSK Rockville has an opening for a Process Informatics Program Manager. In this role, you will lead and manage the Process Informatics team and programs to support biopharmaceutical process manufacturing. Responsible for team strategy including roles and responsibilities, systems, projects, and intended uses. The Process Informatics team is responsible for aggregating and trending process data to support Continued Process Verification activities, statistical process control, investigation of process deviations, and continuous improvement efforts. The team functions within the site?s technical group, BioPharmaceutical Technology, and works closely with the Product Owners
Key Responsibilities:
? Defines and communicates short-term and long-term Process Informatics (PI) strategy, including scope of services & solutions, roles & responsibilities of the PI team, ongoing alignment with manufacturing site priorities, and ongoing communication of PI?s initiatives to other relevant functional areas and the site leadership team
? Manages the Process Informatics team, including setting objectives, staffing, leading, and day-to-day feedback, oversight, and mentoring.
? Program management responsibility for all PI initiatives and projects. Provides direction for setting priorities and communicating expectations/timelines when there are multiple competing requests and priorities.
? Provides direction, support, and leadership to promote the increased utilization of data & relevant informatics tools for proactive decision-making and the support of investigations.
? Maintains relationships and communications with stakeholders across the supply chain, especially for Continued Process Verification / Control Strategy practices (Product Owners, BPT, COE, MFG, R&D, above-site technical teams, EIS, site IT, drug product manufacturing sites, analytical testing laboratories).
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Contact information:
You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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