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You will be updated with latest job alerts via email(ID: 2025-0445)
Axle is a bioscience and information technology company that offers advancements in translational research biomedical informatics and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science software engineering and program management we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Benefits:
Overview
Axle is looking to add a driven flexible organized and meticulous Scientist to our dynamic team. The Contractor(s) shall provide services in support of the overall functions of the Vaccine Research Center (VRC) Vaccine Production Program (VPP) Downstream group and management of process development processes.
Technical Requirements:
OverseethedevelopmentofdownstreamprocessesforVRCclinicalcandidatesandthe process tech transfer to the VCMP for clinical material generation for the VRC.
Provideprojectsupporttoleadscientistsand/orassociatestodevelopdownstreamprocess methodsthatmeettheproductqualityandrecoverycharacteristicstoguaranteesuccessful production of clinical material.
Work with scientists and/or associates in troubleshooting and improving downstream methods during the development cycle. This includes efforts in designing optimization studies(DOEwithJMP)andstreamliningeffortstoensuretimelydevelopmentschedules.
WorkcloselywithProjectManagerstoensuredownstreammilestonesareappropriatelyset and met on time.
Serveasasubjectmatterexpert(SME)inguidingpurificationstrategiesfornewvaccineor therapeutic mAb candidates (both internal to the downstream team and throughout the VPP).
Responsibleforplanningandoverseeingthedownstream processesfortoxicologylotmaterial production.Thisincludesediting/approvingallprocessprotocolsmanagingexecutionthereof and the generation of production reports following successful campaigns.
CoordinatecloselywithManufacturingteamstoensuretimelyandscaleappropriate Technology Transfer is achieved by pursuing the following:
Write/edit/review tech transfer documents (Process Descriptions/Process Flow Diagrams)tosupportVCMPdownstreamprocessMasterBatchRecordauthoring.
ServeasPersoninPlantorassignsteamdesigneeforinitialVCMPproductionruns.
ServeasSMEinVCMPdownstreamtroubleshootingandfacilityfitcalculations.
ServeastheVRCdownstreamSMEinexternalcollaborationsforprojectsoutsideof VCMP-path clinical development
WorkwithregulatoryteamasneededtosupportINDsubmissionsandotherrequests.
Overseeviralclearancestrategiesinrelevantdownstreamprocessesanddirectstheviral clearance validation efforts (SEG evaluation of CRO vendors scale-down method SOP/validation approval etc.
Encourageanddriveinnovationtomeetnewdownstreamchallengesandseekstopublicly
distributenoveltechnologiesthroughpresentationsatconferencesand/orpublicationinpeer- reviewed journals.
Specific Qualifications:
PhDinBioengineeringChemicalEngineeringBiochemistryorarelateddisciplineisrequired.
Minimumofeight(8)yearsofexperienceinrecombinantproteinpurification development for GMP clinical-phase products is required.
Demonstratedknowledgeofmaintainingaccurateanddetailedrecords.
Mustbeateamplayerwhocaneffectivelyworkwithmembersfromcross-functional departments.
Strongoralandwrittencommunicationskills.
Familiaritywithcomputersoftwareincludingwordprocessinganddataevaluation.
The diversity of Axles employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age race gender religion national origin disability marital status covered veteran status sexual orientation status with respect to public assistance and other characteristics protected under state federal or local law and to deter those who aid abet or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills responsibilities duties and/or assignments required. Individuals may be required to perform duties outside of their position job description or responsibilities as needed.
This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidates experience qualifications skills and location.
#INDPSD
Salary Range
$140000 - $150000 USD
Full Time