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Senior Bioprocess Engineer Job
Eingestellt von Yoh
Gesuchte Skills: Engineer, Engineering, Support
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:
- Biopharmaceutical
- Purification
- cGMP
WHAT YOU'LL BE DOING:
- Support the GMS Biopharm introduction and possible scale-up of drug substance processes transferred from R&D, between GMS facilities or from third party clients.
- Develop and prepare technology transfer deliverables, including gap analysis/fit evaluation, process overview documents, bill of materials, sample plans and campaign technical reports.
- Facilitate risk assessments including developing mitigation strategies and control strategies.
- Propose strategies and priorities in planning technical transfer/process validation activities within area of expertise.
- Provide technical oversight for new product introduction (NPI) and lead troubleshooting of technical issues in tech transfers.
WHAT YOU NEED TO BRING TO THE TABLE:
- MS or PhD in either biological or chemical science or engineering or equivalent technical discipline.
- Minimum of five (5) years post-graduate experience in the Biopharmaceutical/pharmaceutical industry to include biopharmaceutical technologies such as large scale cell culture/microbial technology, biopseparations technologies, or pharmaceutical manufacturing of proteins.
- Demonstrated knowledge of current GMP's, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required.
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Eight (8) years experience in biopharmaceutical technical roles with a focus on purification
- Two (2) years of experience in the development of biopharmaceutical drug substance manufacturing processes
- Three (3) years experience in technology transfers, as a lead role.
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Hannah Cihlar
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: HC
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Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Rockville, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges