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Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. This individual is a critical member of the Biomanufacturing team and will oversee all biologics cGMP clinical manufacturing activities including, technology transfer, upstream cell.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Our areas of focus include vaccines, biologics, drugs, microbiome interventions, and reproductive and sexual health. The effective development of preventive and therapeutic interventions (including drugs, vaccines, biologics, microbiome and other interventions) requires an ability to ‘translate’ information from cellular and animal models to human disease and back again.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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In addition, the QM Director will coordinate quality agreements with internal and external sponsors of cell therapy and biologics development and manufacturing for experimental clinical trials.
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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 Cell & Gene Therapy products.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Director, Formulation Development for Pre-pivotal Biologics will be responsible for leading first-in-human formulation development strategies and enable successful pre-pivotal regulatory filings for biologics in multiple therapeutical areas.
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BUSINESS AREABiologics Engineering (BE) is large global organization with teams in Cambridge, UK and Gaithersburg MD responsible for the discovery and optimization of next generation biologics to create biological drug candidates for all key therapeutic areas such as oncology, respiratory and inflammation, cardiovascular, renal and metabolic diseases.
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Innovative mindset to join our Analytical Development group in Woburn, MA. Strong preference will be given to a candidate with proven experience in developing biophysical and analytical chemistry assays like SEC-MALS, HPLCs, CE-SDS, iCIEF as it relates to biologics and gene therapy products.
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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.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Provide Revenue Recognition guidance and financial analysis support to the Finance Director and VP of Finance when quoting new projects or evaluating non-standard circumstances. Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.
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Reporting to the Director, MSAT, you will work with Civica's manufacturing and engineering teams and lead technology transfer for sterile Biologics. Responsible for developing biologics process control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
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This role will provide strategic HR Business Partner leadership to support the local Biologics Operations Leadership Team, in their execution of the Global Product Development & Supply ("GPS") organization's People Strategy.
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The position will independently design, execute, trouble shoot and deliver the projects with LCMS, including small molecules and biologics, as well as lipidomics, glycomics and proteomics. We are seeking a highly motivated and skilled Associate Director (AD) to lead our fast-growing bioanalysis platform.
$112,860 - $158,100 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Assist the General Manager and Director of Finance in establishing metrics, performing budgeting, forecasting, and ad hoc financial/operational analysis related to fixed asset purchases, base cost management, working capital management, headcount control, and operational performance.
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Previous experience in specialty biologics, pharmacy benefit reimbursement/access, specialty pharmacy, and/or Market Access a plus. In this field-based position, the FRM will report to the assigned FRM Director.
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