Sr. Scientist/Associate Principal Scientist
3 weeks ago
- Lead analytical method development, method implementation, product characterization and analytical control strategy development for pre-clinical and clinical stage development programs
- Provide timely technical support and daily management of outsourced drug substance and drug product analytical activities with external partners, including in-process, release and stability testing
- Design and support analytical method transfer and validation activities across a portfolio of small molecule, solid oral dosage projects.
- Lead laboratory investigations to determine root cause and implement corrective actions as needed
- Collaborate with various CMC functions and CMC leadership to develop analytical strategies and deliver on key objectives
- Author and review drug substance and drug product analytical sections for regulatory submissions
- Present to cross functional teams and effectively communicate critical analytical issues and solutions
- Stay current with emerging technologies and industry trends to support Analytical Development
- Perform other duties as assigned
- PhD (>3 years) or MS (>7 years) with related experience in analytical chemistry, organic chemistry, or biochemistry
- Subject matter expertise in analytical method development for various separation and spectroscopic techniques with particular hands-on experience in developing discriminating dissolution test methods
- Experienced in mechanistic and scientific investigations, stability-indicating method development, rapid shelf-life determinations based on ASAP prime software, cGMP stability studies, and creative stability problem solving
- Experience in a GMP regulated analytical environment preferred
- Good understanding of the role of Analytical Development within the drug development process
- Solid leadership skills and interpersonal skills and excellent verbal and written communication skills
- Good understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
- Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain project timelines
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Principal Scientist
1 week ago
Waltham, United States Alkermes, Inc. Full timePosition Summary: The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and grows as a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. They will work within the Analytical Development team to...
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Principal Scientist, Protein Analytics
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Associate Scientist
1 month ago
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Principal Scientist
4 weeks ago
Waltham, Massachusetts, United States Alkermes Full timeJob DescriptionPosition Summary:The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and grows as a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. They will work within the Analytical...
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Associate Scientist
1 month ago
Waltham, United States Cambrex Full timeCompany Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a...
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Waltham, Massachusetts, United States AstraZeneca GmbH Full timeSr. Scientist, Medicinal Chemistry, TTD, Early OncologyThis role is part of an important strategy to deliver highly specific therapeutics including, small molecule, peptide and antibody drug/prodrug/degrader conjugates with various targeting modalities to treat cancer.Design and execute synthetic strategies to access complex target molecules (a strong...
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Associate Scientist
4 weeks ago
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Director, Clinical Scientist
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Senior Scientist, BA
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Associate Director, Clinical Scientist
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Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
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Scientist
4 weeks ago
Waltham, United States Alkermes Full timePosition Summary The Scientist position within Analytical Development performs small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. They develop new methods using chromatographic, characterization, and wet chemistry techniques to enable small molecule drug substance and drug product...
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Associate Director, Clinical Scientist
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Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
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Protein Engineering Scientist
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Bioanalytical Scientist
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Waltham, United States Alloy Therapeutics Full time**The Company** We are Alloy Therapeutics—a biotechnology ecosystem company empowering the global scientific community to make better medicines together. Through a community of partners, we democratize access to pre-competitive tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic...
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Director, Clinical Scientist
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Waltham, United States Neogene Therapeutics Full timePushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available...
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Senior Scientist, Clinical Biomarkers
1 week ago
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Medical Laboratory Scientist
7 days ago
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Senior Scientist
3 weeks ago
Waltham, United States Integrated Resources, Inc ( IRI ) Full timeTitle: Senior Scientist / Non Clinical Safety Evaluation Location: Waltham, MADuration: 6+ Months Part Time role : 20 hours per week Position Summary:Primary responsibility for the Scientist/Senior Scientist in NSE is to ensure timely and high-quality deliverables from NSE to meet Mural Oncology’s Discovery and Development goals; these deliverables include...
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Senior Scientist
5 days ago
Waltham, United States Integrated Resources, Inc ( IRI ) Full timeTitle: Senior Scientist / Non Clinical Safety Evaluation Location: Waltham, MADuration: 6+ Months Part Time role : 20 hours per week Position Summary:Primary responsibility for the Scientist/Senior Scientist in NSE is to ensure timely and high-quality deliverables from NSE to meet Mural Oncology’s Discovery and Development goals; these deliverables include...
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Boston, MA, United States Food Management Search Full timeThis is a contract job opportunity. potential for perm. Position: Medical Laboratory Scientist 8054 Location: Boston MA Schedule: 12:30PM - 9pm or 3PM - 11:30 PM Mon-Friday rotating weekends Projected duration: 6 months + potential for perm Job code: CVDJP00028054 benefits are available OPEN TO BOTH - Medical Lab Technician [2 year MLT...