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Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
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Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry. 2+ year’s post-PhD experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products.
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The candidate will be responsible for formulation and process development activities of oligonucleotide drug product programs to support Biogen's growing pipeline. Biogen is presently looking to fill a Scientist II position within its Anti-Sense Oligonucleotide (ASO) Formulation and Drug Product Development group.
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MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process. Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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A minimum of 6 plus years in a drug discovery/early development function including 2 plus years of experience in a lead role overseeing ADME/DMPK strategy of compound development.
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Amgen is currently seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies - Synthetics (DSTS) group at Cambridge, MA. Amgen’s DSTS group within Process Development (PD) is responsible for the invention and development of drug substance manufacturing processes and technologies to advance Amgen's exciting portfolio of synthetic and hybrid assets.
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3+ years’ experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for peptide drug substances and products.
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10+ years of research and development experience with drug metabolism, with demonstrated experience designing, executing and/or managing outsourced clinical pharmacology and nonclinical studies; experience in small mid size biotech preferred.
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The team is led by our CMO, a physician and medical oncologist with over 25 years of experience in large pharma and biotech drug development. We will consider a Ph. D. with 12 years or more experience in drug development roles in a pharmaceutical industrial R&D setting.
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15+ years product development experience with significant work in developing class II/II medical device or combination drug-delivery products. They will have a track record of innovative electro-mechanical development.
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The role will report to the SVP Finance – CMC & Quality and serve as the finance business partner to three SVP leaders covering: Drug Substance, Resilience, Technical Development. Moderna is looking for a Sr. Director, CMC – Drug Substance & Tech Ops Finance to become the operating group “CFO” for our global drug substance network and technical development areas.
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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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Executive Vice President, VP of Drug Discovery, Head of Medicinal Chemistry. APRINOIA Therapeutics, LLC is seeking a creative and highly motivated scientist to apply innovative medicinal chemistry principles and techniques toward the discovery of medicines for neuroscience as a key contributor to APRINOIA’s business and support the successful discovery and development of the next generation of diagnostic and therapeutic products for the treatment of neurodegenerative diseases, including Alzheimer’s and Parkinson’s disease.
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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. 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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Your solutions will enable data analysis, machine learning and data driven decision-making by therapeutic project teams throughout the drug discovery and early development pipeline. Work with multi-disciplinary teams on projects spanning all aspects of drug discovery: from target discovery through early development.
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drug development jobs in Needham, MA
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