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Partner with Development, Supply Chain, Quality, and Regulatory teams to define technical and regulatory strategies that enable process validation, commercial manufacturing, and post-approval maintenance of Vertex products at current and new suppliers for drug substances.
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Demonstrated project and process expertise guiding antibody or multispecific drug candidate programs from preclinical research into clinical development for treatment of oncology or immune-related disorders.
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Lead drug substance team through preclinical and clinical development to commercialization across Astria’s pipeline. This role will oversee all drug substance process development for the company and will play a key role in driving the portfolio forward from early process development through late stage, including process characterization, validation, and commercialization.
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We are using models early to fail less often, executing clinical trials to add valuation to the company, and generating fit-for-purpose data to feed back into Valo’s Opal Computational Platform as we reinvent drug discovery and development from the ground up.
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We are seeking a Chemical Engineer experienced in small molecule Drug Substance and Drug Product process development and commercial manufacturing to join our Pharmaceutical Development and Manufacturing team.
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Based in Watertown, MA and reporting to the Principal Scientist, Formulation Development, this position is responsible for the formulation and process development of innovative drug delivery platform/drug product device combination for peptides/small molecules.
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BigRio is a leading innovator in healthcare technology, with a dedication to revolutionizing drug discovery and development through advanced data science and artificial intelligence. Proven track record of applying data science to drug discovery and development, particularly in DNencoded library (DEL) machine learning.
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Excellent communication, influencing and presentation skills, with the ability to articulate complex concepts clearly and persuasively to diverse audiences, and high-level understanding of drug discovery and development process.
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As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
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Combination of at least 5-10 years of clinical academic research and/or 3-5 years industry drug development experience (neuromuscular diseases such as ALS a plus, but not necessary) Willingness to work in new drug development areas.
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As the Associate Director, Director or Senior Director of Product Sales and Business Development, you will network within the Drug Discovery industry and generate awareness for TandemAI's innovative new software that is transforming how discovery is executed.
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Our offerings will span across our technology platforms, Process and Analytical Development, Drug Substance and Drug Product offerings from pre-clinical to late phase / commercial supply across five modalities (Cell/Gene/Nucleic Acids/Biologics/Vaccines.
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Has managed drug safety through all Phases of drug development from pre-IND to Phase 4, and with exposure to significant drug development safety issues, including 'clinical holds' and product recalls/withdrawals, and safety-related label changes.
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Prepare formulations and perform characterization assays/data analysis with focus on in vivo studies, drug carrier design/development, assay development etc. Support vaccine formulation development activities.
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Expert knowledge in drug development principles (pre-clinical and clinical toxicology, translational medicine, clinical biomarkers, etc.) Expert technical knowledge as it relates to phase gated assay development, pre-clinical and clinical sample testing and bioanalysis (GLP/GCLP/GXP.
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drug development jobs in Boston, MA
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