Scientist II, Analytical Development Specialist
2 weeks ago
AbbVie is seeking a highly skilled Scientist II, Analytical Development to support the development and implementation of analytical methods for late-phase antibody-drug conjugate (ADC) development.
Key Responsibilities- Support Analytical Method Lifecycle Activities: Collaborate with external AD/QC laboratories to ensure the development and validation of analytical methods for IPC, release, and stability testing.
- Manage Reference Standard Programs: Oversee the development, qualification, and management of antibody and ADC reference standards for all development phases.
- Author and Review Documentation: Develop and review protocols, reports, and test methods related to analytical method development and validation.
- Collaborate with Cross-Functional Teams: Work closely with QA, manufacturing sciences, regulatory CMC, and supply chain to support program objectives.
- Perform Statistical Analysis: Conduct statistical analysis of batch data to support specification setting and product comparability studies.
- Support Regulatory CMC Activities: Assist with regulatory filings, information requests, and in-country registration testing.
- Ph.D. in Analytical Chemistry or related field.
- Minimum 5 years of experience in analytical method development and validation.
- Strong understanding of GMP regulations and industry standards.
- Excellent communication and collaboration skills.
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Scientist II, Analytical Development Specialist
2 weeks ago
Waltham, Massachusetts, United States AbbVie Full timeJob Summary:AbbVie is seeking a highly skilled Scientist II, Analytical Development to support the development and implementation of analytical methods for late-phase antibody-drug conjugate (ADC) development. The successful candidate will be responsible for managing the analytical method lifecycle, including validations, re-validations, transfers, and...
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Scientist, Analytical Development Specialist
3 weeks ago
Waltham, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob OverviewThis position seeks a passionate analytical scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Key ResponsibilitiesLead analytical technology transfers, collaborating with teams and mitigating risks.Validate analytical methods...
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Senior Analytical Development Scientist
1 week ago
Waltham, Massachusetts, United States Alkermes Full timeJob SummaryThe Associate Principal Scientist position within Analytical Development at Alkermes leads small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. This role collaborates with cross-functional teams on analytical method development, molecule characterization, testing, and analysis throughout various...
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Senior Analytical Scientist
2 weeks ago
Cambridge, Massachusetts, United States AbbVie Full timeJob SummaryWe are seeking a highly motivated and experienced analytical scientist to lead a team of analytical scientists supporting early phase development of New Chemical Entities (NCEs) drug substance and drug product in both preclinical and clinical. The ideal candidate will have extensive expertise in applying regulatory guidelines within an R&D...
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Scientist, Analytical Development
1 day ago
Waltham, Massachusetts, United States Dyne Tx Full timeJob Title: Scientist, Analytical Development & Quality ControlJob Summary:The Scientist, Analytical Development & Quality Control will be responsible for the development, optimization, and validation of analytical methods for proteins, monoclonal antibodies, and drug conjugates. This role will also involve leading daily lab operations, managing CMC process...
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Scientist, Analytical Development 2043785
3 weeks ago
waltham, United States Stratacuity: Proven Scientific Placement Full timeLocation: Waltham, MA (Hybrid)Therapeutic Area: Gene TherapyJob Overview: This position seeks a passionate analytic scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Primary Job Responsibilities:Lead analytical technology transfers,...
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Scientist, Analytical Development 2043785
3 weeks ago
Waltham, United States Stratacuity: Proven Scientific Placement Full timeLocation: Waltham, MA (Hybrid)Therapeutic Area: Gene TherapyJob Overview: This position seeks a passionate analytic scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Primary Job Responsibilities:Lead analytical technology transfers,...
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Scientist, Analytical Development 2043785
3 weeks ago
Waltham, United States Stratacuity: Proven Scientific Placement Full timeLocation: Waltham, MA (Hybrid)Therapeutic Area: Gene TherapyJob Overview: This position seeks a passionate analytic scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Primary Job Responsibilities:Lead analytical technology transfers,...
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Scientist, Analytical Development 2043785
3 weeks ago
waltham, United States Stratacuity: Proven Scientific Placement Full timeLocation: Waltham, MA (Hybrid)Therapeutic Area: Gene TherapyJob Overview: This position seeks a passionate analytic scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Primary Job Responsibilities:Lead analytical technology transfers,...
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Senior Process Development Scientist
1 week ago
Waltham, Massachusetts, United States AbbVie Full timeJob SummaryWe are seeking a highly skilled Senior Process Development Scientist to join our team at AbbVie. As a key member of our process development group, you will be responsible for driving late-stage process development activities of novel antibody-drug conjugates (ADCs).Key ResponsibilitiesIndependently design, execute, and interpret critical...
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Scientist, Analytical Development
2 months ago
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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Senior Analytical Development Scientist
2 weeks ago
Cambridge, Massachusetts, United States Foghorn Therapeutics Full timeAbout the RoleFoghorn Therapeutics is seeking a highly skilled and experienced Senior Analytical Development Scientist to join our team. As a key member of our Analytical Development and Quality Control department, you will be responsible for driving the analytical development and QC functions, ensuring the successful advancement of small molecule candidates...
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Analytical Process Development Scientist
1 week ago
Boston, Massachusetts, United States Eurofins USA PSS Insourcing Solutions Full timeJob SummaryAs a key member of our Research Vector group, you will play a crucial role in the production and purification of research-grade AAV vectors. Your expertise will support client drug substance process development and characterization.ResponsibilitiesPerform routine analytical assays on a weekly basis to determine product quality and...
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Principal Data Analytics Scientist
3 weeks ago
Waltham, Massachusetts, United States Dyne Tx Full timeAbout Dyne TxDyne Tx is a clinical-stage biotechnology company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.Job SummaryThe Principal Data Analytics Scientist will be a critical contributor to data analytics and engineering focused on accelerating our R&D programs and expanding our...
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Waltham, United States Beacon Hill Life Sciences - Boston Full timeJob DescriptionJob DescriptionOur Client is looking for a Principal Associate Scientist to support the development and execution of novel molecular methods from the Analytical Development teams. The position will work closely with the AD SMEs, Analytical Testing Core and the QC team and will also participate in method optimization and lifecycle management...
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Analytical Chemist, Biotechnology Development
3 weeks ago
Waltham, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob OverviewThis position seeks a passionate analytical scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Key ResponsibilitiesLead analytical technology transfers, collaborating with teams and mitigating risks.Validate analytical methods...
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Analytical Laboratory Development Scientist
2 weeks ago
Boston, Massachusetts, United States Eurofins USA PSS Insourcing Solutions Full timeJob SummaryWe are seeking a highly skilled Biopharmaceutical Product Development Specialist to join our team at Eurofins USA PSS Insourcing Solutions. As a key member of our laboratory team, you will be responsible for the development and implementation of analytical methods for biopharmaceutical drug products.Key Responsibilities:Routinely perform batch and...
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Cell Culture Scientist II
3 weeks ago
Waltham, Massachusetts, United States Repligen Full timeJob SummaryWe are seeking a highly skilled Cell Culture Scientist II to join our team at Repligen. As a key member of our bioprocessing team, you will be responsible for developing and optimizing cell culture processes for monoclonal antibody, recombinant protein, and viral vector production.Key ResponsibilitiesCell Culture Process Development: Design,...
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Senior Research Scientist, Process Development
2 weeks ago
Waltham, Massachusetts, United States AbbVie Full timeJob Summary:AbbVie is seeking a highly skilled Senior Research Scientist to join our Process Development team. As a key member of our team, you will be responsible for driving late-stage process development activities of novel antibody-drug conjugates (ADCs).Key Responsibilities:Independently design, execute, and interpret critical experiments to answer...
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Senior Scientist, II
7 days ago
Cambridge, Massachusetts, United States AbbVie Full timeJob Overview AbbVie's Molecular Profiling and Drug Delivery (MPDD) organization is seeking a highly motivated and talented scientist to serve as a Senior Scientist II. The primary role of this position is to lead CMC developability assessment for emerging molecules on small molecule pipeline programs. The successful candidate will work collaboratively with...