NBMBAA 2016 Sr Bioprocess Engineer / Technology Manager

NBMBAA 2016 Sr Bioprocess Engineer / Technology Manager
+ Requisition ID:142419
+ Position:
+ Open date:Oct 5, 2016 2:37 PM
+ Functional area:Engineering
+ Location:Maryland
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+ + Required degrees:Bachelors
+ Experience required:5 years
+ Relocation:Not Indicated
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Basic qualifications:BS/BA in either biological or chemical science or engineering or equivalent technical discipline.
A minimum of 5 years post-graduate experience in the Biopharmaceutical/ pharmaceutical industry to include biopharmaceutical technologies such as large scale cell culture / microbial technology, bioseparations technologies, or pharmaceutical manufacturing of proteins.
Knowledge of current GMP?s, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required.
Preferred qualifications:MS or PhD in either biological or chemical science or engineering or equivalent technical discipline. MS in discipline if sufficient scientific and technical depth has been achieved from professional experience.
At least 2 years of experience in the development of biopharmaceutical drug substance manufacturing processes.
Experience in technology transfer and conducting root cause analysis for GMP manufacturing deviations.
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 Biopharm currently has an opening for a Senior Bioprocess Engineer in the BioPharmaceutical Technology (BPT) team at the Biopharm manufacturing site located in Rockville, MD. BPT is responsible for scale-up, tech transfer, commercial lab support, and technical process oversight for internal GSK products into the three Rockville GMP facilities. It is also responsible for CMO process development, process characterization, small scale validation and tech transfer for any CMO processes going to it?s five GSK commercial-scale GMP Drug Substance facilities (three facilities in Rockville as well as two facilities in Upper Merion, PA). The Rockville BPT team is comprised of 2 functions i) a technical oversight function for product technical lifecycle management and ii) a process laboratory function in its new state of the art lab opened in 2014, containing bench scale as well as pilot scale (200 L) operations.
This Senior Bioprocess Engineer role is in the technical oversight function, providing cross functional project leadership and technical support for GSK?s three Rockville GMP manufacturing facilities, with upstream scales ranging from 1,600 L to 20,000 L. The BPT role supports GSK and 3rd party tech transfer and validation (PPQ) of drug substance biopharmaceutical products. The role also supports delivering improvements to the existing supply chains and continuously reducing product cost of goods, while improving product quality.
Reporting to the Senior Technology Manager (Product Owner), you will be expected to lead complex technical projects utilizing diverse, cross-functional teams to complete these efforts. These projects will include technology transfers into manufacturing, new technology introductions, process optimization and leading major manufacturing investigations.
Contact information:
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