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Experience in the development of computational tools for drug design. BIOVIA is looking for a motivated Machine Learning Engineer – Drug Discovery to join our Discovery Studio team in San Diego, CA, or Waltham, MA in an onsite/hybrid role.
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Qualified candidates must have a PhD in synthetic/organic chemistry or related scientific field with 15+ years’ experience in drug substance development and manufacturing and a proven track record in developing and scaling up chemical process to kilo lab, pilot plant and commercial plant scales.
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MD with 10+ years of experience in drug development and drug safety/pharmacovigilance, with specific expertise in clinical oncology, immunology, or genetics. Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
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Drive cross-functional collaboration across our data science, machine learning, lab informatics, and medicinal chemistry teams to advance our computational infrastructure for our drug discovery and development mission.
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Extensive experience in assay development and proficiency in drug discovery and development, including delivering data and documentation supporting IND/CTA regulatory filings. This key leadership role will require an individual to direct and oversee in vitro pharmacology efforts, participating in drug discovery and early development activities.
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Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.
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Lead cross-functional program teams, relying on expertise from across on company and interface with various current and future teams at Quotient, such as Medicinal Chemistry, Platform Biology, Development (DMPK, Preclinical Drug Safety, Clinical Pharmacology and Medicine) and with the Quotient leadership team.
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This position offers a unique opportunity to work and grow in a dynamic and innovative environment developing your career at the interface of mechanistic research, drug discovery, and preclinical drug development.
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Responsible for all aspects drug substance including conjugation process development, validation, characterization, scale-up, tech transfer, analytical method qualification, specifications, release and stability testing.
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Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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Serve as drug product SME to support CMC and program teams in technical due diligence, CRO and CMO capability assessment, selection, and management for formulation and drug product development and manufacture.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Demonstrated track record of success in leading translational research efforts within the biopharmaceutical industry, with specific experience in antibody-based drug development for oncology/immunology.
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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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Cell-Based Assays Senior or Principal Scientist, Analytical Development. Experience in protein/protein, protein/RNA, RNA/small molecule or protein/small molecule interactions by DSF, ITC, and/or MST and have applied these to small molecule drug discovery preferred.
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drug development jobs in Waltham, MA
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