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The candidate is expected to proficiently manage manufacturing aspects of commercial support of biologics drug substance process throughout the product life cycle: from technology transfer, process validation to commercial manufacturing, and process improvement in order to meet the financial, quality and throughput objectives.
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Serve as a QTAS representative on project teams supporting the development of novel biologics; collaborate with project team members (e.g., clinical pharmacology, protein analytics, discovery, toxicology) and groups within QTAS to generate relevant data guiding target validation, biomarker selection, and candidate selection.
ExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products.
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The Biologics Virus Clearance Validation Leader is responsible for cell culture and purification process stretching studies, resin lifetime studies, buffer/solution hold time studies, at-scale membrane and resin lifetime verification studies, virus clearance studies, limit of in-vitro cell age studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.
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Extensive expertise in U/HPLC, CE, SDS-PAGE, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. This person is responsible for the governance of the GMP facility environmental monitoring and contamination control program including the qualification of the GMP facility and maintaining the qualified status, aseptic process simulation, disinfection procedures/practices, disinfectants qualification, cleaning validation, and oversight of microbiological testing of raw materials, intermediates, drug substance, and finished goods.
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Collaborating with cross-functional groups including Manufacturing, Quality Control, IT, Engineering, and Validation to identify risks, develop mitigation strategies, and resolve issues, ensuring the smooth functioning of Quality systems including TrackWise QMS, Veeva and Labware.
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Proven track record of analytical development leadership for biologics and small molecules, experience with vaccines, carbohydrate, or conjugates is a plus. Experience in protein characterization by using different analytical approaches, such as aggregates by SEC-LC, charge variants by AEX, HCP by CE-SDS, peptide mapping and intact mass analysis by LC/MS/MS, and protein quantitation by SoloVPE and other colorimetric assays.
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Apply a fundamental understanding of Upstream (Cell Culture) bioprocessing to support biologics technology transfer, process validation, and plant start-up. In this vital role you will be a part of the Process Development Drug Substance Technology group at Amgens FleX Batch Biologics Manufacturing Facility.
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Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products. Support the development and validation of analytical methods used for QC testing of small molecule and oligonucleotide products.
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Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role. Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
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Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations. Senior Director, Quality Assurance – Formulation and FillPosition Summary: Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help bring biologic treatments to our patients.
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We offer our clients comprehensive service platforms around target validation, plate-based pharmacology, hit identification and lead discovery, in vivo pharmacology, as well as other research and development services.
$112,860 - $158,100 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Experience with AAV gene therapy drug development, bench to bedside and with biologics drug discovery and development. In-depth familiarity with target validation and lead identification and optimization using molecular, cellular, and in vivo methodologies.
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Knowledge of biologics regulatory guidelines including FDA/ICH on risk management, technology transfer and process validation. Strong background and subject matter expertise in purification unit operations including column chromatography, filtration (UF, DF, TFF), harvest and viral clearance validation in the manufacture of recombinant proteins and antibodies.
$160,000 - $200,000 a yearExpandApply NowActive JobUpdated 4 days ago
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