Engineer I

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Elkton, United States Innova Solutions Full time

Job Description: As a member of Process Development, the primary goal of the position is to: •Characterize proteins, VLPs and constituent components with a variety of analytical techniques •Participate in/drive fermentation and/or purification of proteins/VLPs at lab and pilot scale •Provide support for execution of process development activities and manufacturing investigations •Perform laboratory scale studies •Design and troubleshoot experiments •Employ excellent verbal and written communication skills •Author laboratory notebooks and technical documents •Work both independently and within multidisciplinary team •Produce high quality work against firm deadlines •Maintain good sample handling practices •Balance and prioritize competing deliverables •Commit to creating a diverse and inclusive workplace This position will report to the Technical Operations Department and will support the manufacture of HPV Gardasil as part of a multidisciplinary team, the candidate will have a fundamental knowledge of fermentation and cell culture, protein chemistry and purification, analytical techniques and/or laboratory operations. Join our Process Development Team in using a variety of fermentation techniques, purification techniques, and characterization methods to support commercial and bench scale pharmaceutical processes. The PD team uses a scale down model to provide investigation support, promote process understanding, and facilitate technology transfer of products to the Elkton site. We work with teams across the network to bridge process, quality, and analytical principles and synthesize these into a focused laboratory that provides high quality support to realize the sustained production of medication for patients.

Responsibilities: As a member of Process Development, the primary goal of the position is to: •Characterize proteins, VLPs and constituent components with a variety of analytical techniques •Participate in/drive fermentation and/or purification of proteins/VLPs at lab and pilot scale •Provide support for execution of process development activities and manufacturing investigations •Perform laboratory scale studies •Design and troubleshoot experiments •Employ excellent verbal and written communication skills •Author laboratory notebooks and technical documents •Work both independently and within multidisciplinary team •Produce high quality work against firm deadlines •Maintain good sample handling practices •Balance and prioritize competing deliverables •Commit to creating a diverse and inclusive workplace This position will report to the Technical Operations Department and will support the manufacture of HPV Gardasil as part of a multidisciplinary team, the candidate will have a fundamental knowledge of fermentation and cell culture, protein chemistry and purification, analytical techniques and/or laboratory operations. Join our Process Development Team in using a variety of fermentation techniques, purification techniques, and characterization methods to support commercial and bench scale pharmaceutical processes. The PD team uses a scale down model to provide investigation support, promote process understanding, and facilitate technology transfer of products to the Elkton site. We work with teams across the network to bridge process, quality, and analytical principles and synthesize these into a focused laboratory that provides high quality support to realize the sustained production of medication for patients.

Qualifications: Education Minimum Requirement: A bachelor's degree in a relevant scientific discipline (biochemistry, chemistry, biology), life sciences, Engineering Required Experience and Skills •Wet chemistry laboratory skills (pipetting, buffer preparation, filtration, dilution, stoichiometry) •Proficiency with technical writing and laboratory records (laboratory notebooks, chemical inventory, data management) •Excellent collaborative and team-working skills •Strong technical problem-solving abilities, data interpretation and presentation competence Preferred Experience and Skills: •Experience working with analytical instrumentation (plate readers, densitometers, thermocyclers, cIEF, UV/Vis spectrophotometers, HPLC/ UPLC systems) •Experience working with tangential flow filtration processing - microfiltration/ultrafiltration •Experience working with protein purification •Experience working with column chromatography and AKTA/Unicorn systems •Experience performing fermentation or cell culture studies at the labs scale •Experience performing fermentation or cell culture studies using shake flasks •Knowledge of yeast fermentation and metabolism •Experience working in GMP and GLP environments •Experience with laboratory operations •Experience with facility operations •Experience working in an industry environments •Experience conducting laboratory scale process characterization studies •Experience troubleshooting technical issues (experimental, equipment-related issues) •Experience with material characterization •Experience working with enzymes and peptides •Experience in method development and method transfer •Experience with six sigma, 5S principles

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