Principal Scientist for Macromolecule Analysis

2 weeks ago

Cambridge, Massachusetts, United States GlaxoSmithKline Full time

Position Overview:
The Senior Analytical Scientist will be responsible for spearheading, designing, and executing scientific investigations that support technical initiatives as they transition from early development stages through to Phase I/II and Phase III, as well as technology transfer and process performance qualification at the designated commercial facility.


This role demands a commitment to cutting-edge analytical development for macromolecule evaluation (including polysaccharides, proteins, and virus-like particles), adhering to Quality by Design (QbD) principles in the following areas:
Separation Sciences technologies (including UHPLC, GC-FID/MS, Headspace-GC, LC-MS, capillary electrophoresis, content testing, impurities, identity testing, etc.).

Key Responsibilities:


Lead a dedicated team of 4-5 professionals through the comprehensive analytical method development lifecycle, from initial concept to GMP-compliant testing and validation.

Independently oversee the conception, design, and implementation of analytical methodologies, as well as the interpretation of scientific and technical data to support various projects.

Drive specific development workstreams autonomously, aligning with business priorities while adhering to the Quality by Design framework.
Effectively function as a core team member across multiple concurrent project workstreams and established operational processes. Tackle complex challenges through collaboration, bringing fresh perspectives to existing solutions.

Foster strong relationships in the technical development domain with high-quality partners, both internally and externally, to enhance the development and implementation of new methodologies and technologies.

Author and review technical protocols, reports, and manufacturing support documents throughout various project development phases. Make informed scientific, technical, and business decisions based on a balanced assessment of data, analysis, and experience.
Prepare and present scientific findings within Technical R&D, including the Technical Development Team, and may represent the organization externally at conferences and similar events. Leverage technical process knowledge to fulfill regulatory requirements appropriate for the development stage.
Benchmark specific technologies within the functional area to elevate the technology to state-of-the-art standards. Contribute to and drive strategic and technical development planning, ensuring accountability in execution.

Collaborate with and/or lead scientific personnel, providing mentorship to new team members and serving as a resource for less experienced colleagues.

Ensure the execution of the function's risk assessment and escalate issues to relevant bodies. Participate in the development of mitigation strategies.
Lead and enforce compliance with GxP/EHS/QA regulations.

Ensure the GMP release testing and stability of all investigational Phase I/II/III vaccines are conducted in accordance with timelines and GMP requirements.

Participate in and lead the validation of analytical methods, as well as the transfer of validated analytical methods from the analytical research and development group to commercial quality control or other partners.

Write validation and transfer protocols and reports.

Communicate effectively within Technical R&D and with external stakeholders, defending scientific and technical decisions at the appropriate technical boards. Act as a representative and ambassador for the department in various governance bodies and meetings.

Basic Qualifications:
We seek professionals with the following essential skills to achieve our objectives:
Bachelor's degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.

6+ years of experience in designing and executing scientific studies that support technical programs and the biopharma/vaccine development process.

Experience in the analytical characterization of macromolecules, particularly polysaccharides, glycoproteins, and glycoconjugates.
Experience with Separation Sciences technologies (including UHPLC, GC-FID/MS, Headspace-GC, LC-MS, capillary electrophoresis, content testing, impurities, identity testing, etc.).
Experience in a GMP laboratory setting.

Preferred Qualifications:
If you possess the following attributes, it would be advantageous:

PhD in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific field, with 3-4+ years of experience in analytical development supporting the biopharma/vaccine development process.

Experience in method qualification/validation and a solid understanding of QbD principles.
Experience in data analysis automation and/or real-time release testing would be beneficial.
Experience in technology transfer within a quality control environment. Ability to collaborate effectively with cross-functional teams and communicate proficiently.
Utilize technical process knowledge to meet regulatory requirements appropriate for the development stage.
Make informed scientific, technical, and business decisions based on a balanced assessment of data, analysis, and experience.
Address complex challenges through collaboration, offering innovative perspectives on existing solutions.
Ability to work effectively within a dedicated team of scientists.
Communicate proficiently within Technical R&D and with external stakeholders (including universities, CMOs, and presenting at scientific conferences) while defending scientific and technical decisions at the appropriate technical boards.
Possess the ability to influence scientific and technical vision and strategy.

  • Senior Scientist, Biomolecular Analysis Specialist

    5 days ago

    Cambridge, Massachusetts, United States The University of Texas MD Anderson Cancer Center Full time

    Job Title: Principal/Senior/Scientist, Biomolecular AnalysisJob Summary:We are seeking a highly skilled Senior Scientist, Biomolecular Analysis Specialist to join our team at The University of Texas MD Anderson Cancer Center. As a key member of our research team, you will be responsible for driving the biomolecular characterization to support platform...

  • Principal Scientist

    1 month ago

    Cambridge, Massachusetts, United States Nuvalent, Inc Full time

    Reporting to the VP, Medicinal Chemistry, the Principal Scientist, Medicinal Chemistry will have strong technical and problem-solving skills in organic and medicinal chemistry skills.The scientist in this position will work with the Nuvalent team, including the scientific founder, and will be responsible for leading medicinal chemistry efforts on at least...

  • Senior Analytical Scientist

    2 weeks ago

    Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    Position Overview:The Senior Analytical Scientist will spearhead the design and execution of scientific investigations to support technical initiatives as they transition from preliminary development through various phases of clinical trials and into commercial readiness.This role demands expertise in cutting-edge analytical methodologies for macromolecule...

  • Principal Associate Scientist: Analytical Development

    2 months ago

    Cambridge, Massachusetts, United States Proclinical Full time

    Principal Associate Scientist for Analytical Development - Contract - Cambridge, MA Proclinical is actively seeking a Principal Associate Scientist. This is a temporary contract position based in Cambridge, Massachusetts, MA. Primary Responsibilities:This role is primarily focused on the initial characterization testing, annual re-qualification, and trending...

  • Principal Scientist in Drug Development

    5 days ago

    Cambridge, Massachusetts, United States Newton Colmore Full time

    About the RoleWe are seeking a highly experienced Senior DMPK and ADME Expert to join our research team at Newton Colmore. As a Principal Scientist in Drug Development, you will play a key role in designing and implementing in vivo PK studies, providing updates and results to research teams, and presenting strategies at governance interactions.Key...

  • Expert Scientist mRNA Vaccine Development

    3 days ago

    Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    About the RoleWe are seeking a highly skilled and experienced Expert Scientist to join our team at GlaxoSmithKline (GSK) in the development of mRNA-based vaccines. As a key member of our research team, you will play a critical role in leading, designing, and executing scientific studies to support the development of new mRNA-based vaccines.Key...

  • Senior Principal Scientist

    2 days ago

    Cambridge, Massachusetts, United States Novartis Group Companies Full time

    Job SummaryAs a Senior Principal Scientist in the Translational Medicine Drug Disposition Bioanalytical group at Novartis Group Companies, you will have the opportunity to make a significant impact in the development of novel modality biologics. This vital leadership role requires a collaborative nature, a commitment to teamwork, and a relentless focus on...

  • Process Development Senior Principal Scientist

    3 months ago

    Cambridge, Massachusetts, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...

  • Principal Scientist

    5 days ago

    Cambridge, Massachusetts, United States Novartis Group Companies Full time

    Job SummaryWe are seeking an experienced Senior Principal Scientist or Principal Scientist to join our Oncology Research and Development team at Novartis Group Companies. The successful candidate will be responsible for developing and implementing pharmacokinetics and clinical pharmacology strategies to support the development of innovative medicines.Key...

  • Expert Scientist

    1 month ago

    Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: Cambridge Binney StreetPosted Date: Aug 2 2024The Expert Scientist is expected to lead, design and execute scientific studies in support of technical programs as they progress from early development into Phase I/ II, Phase III, technology transfer and process performance qualification at the intended commercial site.He/she will ensure state of the...

  • Senior Principal Scientist in GCP Bioanalysis

    1 week ago

    Cambridge, Massachusetts, United States Novartis Group Companies Full time

    Position OverviewJoin our team as a Senior Principal Scientist within the Translational Medicine Drug Disposition Bioanalytical division. This role offers a unique opportunity to enhance your leadership capabilities while contributing to our mission of improving patient outcomes. We seek individuals who thrive in collaborative environments and are dedicated...

  • Principal Scientist, Discovery Chemistry

    4 days ago

    Cambridge, Massachusetts, United States Sarepta Therapeutics Full time

    About the RoleWe are seeking a highly skilled and experienced Principal Scientist to join our RNA Research group at Sarepta Therapeutics. As a key member of our dynamic and fast-paced chemistry team, you will be responsible for designing and conducting novel oligonucleotide conjugates synthesis, purification, and characterization. You will also apply...

  • Principal NLP Machine Learning Scientist

    1 day ago

    Cambridge, Massachusetts, United States DeepRec Full time

    Job Title: Principal NLP Machine Learning ScientistAbout the Role:We are seeking a highly skilled Principal Machine Learning Scientist to join our team at DeepRec. As a key member of our team, you will be responsible for developing and training large-scale language models, fine-tuning models with feedback, and integrating multimodal scientific data.Key...

  • Principal Scientist

    3 days ago

    Cambridge, Massachusetts, United States Bristol-Myers Squibb Full time

    About the RoleBristol-Myers Squibb is seeking a highly skilled Principal Scientist to join our Computational Design and Predictive Modeling team in Cambridge, MA. As a key member of our team, you will play a critical role in developing novel bioinformatics and machine learning solutions to analyze and characterize antibody repertoire sequencing data.Key...

  • Senior Principal Scientist

    5 days ago

    Cambridge, Massachusetts, United States Novartis Farmacéutica Full time

    About the RoleIn this vital leadership position, you will use your leadership skills, scientific acumen, operational excellence, and regulated bioanalysis experience to lead a team of scientists in method development, validation, and sample analysis focusing on our novel modality biologics portfolio.Your Key Responsibilities Will Include:Overseeing the...

  • Expert Scientist mRNA hub

    1 month ago

    Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade . R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We believe the Greater Boston area is an important hub for the biotech and pharma industry,...

  • Process Development Sr Principal Scientist

    2 months ago

    Cambridge, Massachusetts, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...

  • Lead Scientist, Biomolecular Characterization

    2 weeks ago

    Cambridge, Massachusetts, United States The University of Texas MD Anderson Cancer Center Full time

    Position Title: Lead Scientist, Biomolecular CharacterizationLocation: United StatesPosition Overview:In this role, you will spearhead the biomolecular analysis to facilitate platform innovation and ensure product quality control. Your primary focus will be on the development of bioanalytical assays to evaluate mRNA integrity, capping efficiency,...

  • Principal Scientist, Drug Product Development

    3 days ago

    Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    About the RoleWe are seeking a highly skilled and experienced Principal Scientist, Drug Product Development to join our CMC Technical Operations team at Akebia Therapeutics. As a key member of our team, you will be responsible for providing strategic and technical leadership in the development and execution of drug product strategies for our clinical and...

  • Principal Scientist, Drug Product Development

    7 hours ago

    Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    About the RoleWe are seeking a highly skilled and experienced Principal Scientist, Drug Product Development to join our CMC Technical Operations team at Akebia Therapeutics. As a key member of our team, you will be responsible for providing strategic and technical leadership in the development and execution of drug product strategies for our clinical and...