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Our global team of over 2,500 employees drive our capabilities in product development, product formulation, strategic sourcing, manufacturing, packaging design, brand marketing, project management, quality assurance, compliance, distribution, and logistics.
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PhD in Pharmaceutical Sciences, Biophysics, Biochemistry or a relevant discipline and 5 years of industry experience preferably in vaccine formulation development, or at least in biologics such as proteins or protein conjugates.
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Cardinal Health Regulatory Sciences has a diverse portfolio of projects spanning large, publicly traded organizations to venture/private equity backed drug and medical device entities across a range of therapeutic categories and formulation varieties.
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Develop stable and fit-for-purpose liquid and lyophilized drug products through the design and execution of formulation, process development, and clinical in-use studies. The Biologics Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept.
$78Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Demonstrates knowledge of global clinical trials and the drug development process, Knowledge of IRT system setup and functionality and proficiency with Excel modeling, Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams.
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Demonstrated knowledge and expertise in drug product development, formulation development, process development, manufacturing, and regulatory CMC. Lead the execution of formulation, compatibility, and process development studies to support phase appropriate development of Dynavax’s drug product portfolio.
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Collaborate closely with other departments, including Formulation and Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain, to ensure seamless integration of packaging processes with overall drug product manufacturing and distribution operations.
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Support formulation development activities, including stability studies for thermal, freeze/thaw, and agitation, kinetic analysis of antigen degradation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
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You will be responsible for leading formulation development across early and late stage programs, working closely with other internal groups and CROs/CDMOs∯*∯ You will have the opportunity to join a growing biotech organization with a robust pipeline of vaccines to combat infectious diseases across the globe.
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You will track and report project scope/timeline/milestone status associated with technical transfer (analytical/process), regulatory strategies and commitments, product manufacturing, process validation, product testing, capacity planning, drug formulation, clinical trial material manufacture and external partner strategy.
$70,000 - $85,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Extensive experience in pharmaceuticals development, formulation, or drug product manufacturing process development. Minimum of 10 years of relevant Regulatory Affairs experience, regionally or globally, encompassing early and late-stage development and commercial manufacturing.
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Job DescriptionThe Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.
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Drug Hunting Focus: The candidate is expected to exhibit strong problem-solving abilities and be familiar with understanding and resolving issues that lie at the interface of peptide discovery, peptide engineering, pharmaceutical developability and formulation, and biology.
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An ideal candidate would have good understanding of drug product process development and nanoparticle formulation. Uses knowledge and expertise of statistics to collaborate with scientists in application of statistics to Drug Product Development: Quality by Design, formulation development and optimization, process design and optimization, experimental manufacturing campaigns, determining manufacturing design spaces, validation, experimental and registrational stability studies, probabilistic assessment of risk for critical quality attributes.
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15+ years experience in drug development (start-up to final study report) Steer the formulation and execution of Study Management standardizations, encouraging adaptability for swift execution and inventive solutions.
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drug development formulation jobs
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