Process Informatics Manager at GlaxoSmithKline
Posted in Information Technology 9 days ago.
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Location: Conshohocken, Pennsylvania
Position Title: Process Informatics Manager
Working Location: Pennsylvania
Employment Status: Full time
Required Experience: 5 years
Required Education: Bachelors
Travel Required: 0%
Manage the process informatics group within the GMS Biopharm business providing statistical consulting and process informatics support to the biopharm manufacturing business. The scope of responsibility includes support of mid/late phase biopharm assets entering GMS through to commercially mature biopharm assets. Groups to be supported include: Building 40, BioCTL, Biopharm CoE, 3rd Party Supply, R&D and others as necessary.
• Manage and provide a high level of statistical expertise/data management capability to support BioPharm operations.
• Accountability for the development and deployment of the strategic plan for the management of BioPharm process data. This will include data from production, internal and external quality, tech transfer activities, stability, special studies and protocols, lab controls and others as necessary.
• Responsible for insuring alignment of statistics/process informatics approaches in a matrixed environment including other GMS Biopharm manufacturing facilities, Biopharm R&D, Global Technical groups, Biopharm CoE, 3rd Party Quality, External suppliers, BioCTL and others as required.
• Responsible for interfacing with the key statistical groups in R&D working on Biopharm products.
• Provide direction and career development to direct/indirect team members.
• Develop and implement training and mentoring programs to support the Biopharm business across GMS in the areas of applied statistics and process informatics.
• Provide technical solutions that require a sophisticated level of programming, statistical and database expertise.
• Represent GSK at meetings with regulatory authorities KOL’s, etc.
• Bachelors Degree or equivalent encompassing aspects of process informatics and/or statistical data analysis.
• 5- 10 years experience in process informatics and/or statistics in pharma or related industry.
• Familiarity with relational databases to include SQL, relational schemas and data structures.
• Experience with statistical analysis software
• Experience in a manufacturing/ engineering environment
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.