Senior Analytical Scientist
2 weeks ago
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 evaluation, including polysaccharides and proteins, adhering to Quality by Design (QbD) principles. The focus will be on:
Advanced Separation Science techniques (e.g., UHPLC, GC-FID/MS, Headspace-GC, LC-MS, capillary electrophoresis, and various testing protocols for content, impurities, and identity).
Key Responsibilities:
Oversee a team of 4-5 professionals throughout the comprehensive analytical method development lifecycle, ensuring compliance with GMP standards.
Take independent charge of the conception, design, and execution of analytical methodologies, alongside the interpretation of scientific and technical data to bolster project objectives.
Lead specific development workstreams autonomously, aligning with business goals while adhering to the Quality by Design framework.Collaborate effectively as a core team member across multiple concurrent project initiatives, employing innovative problem-solving strategies in partnership with colleagues.
Foster robust relationships in technical development with high-caliber partners, both internally and externally, to enhance the implementation of novel methods and technologies.
Draft and evaluate technical protocols, reports, and manufacturing support documents throughout various project stages. Make informed scientific and technical decisions based on a comprehensive analysis of data and experience.Prepare and present scientific findings within Technical R&D, including the Technical Development Team, and represent the organization at external scientific forums.
Utilize technical process knowledge to fulfill regulatory requirements pertinent to the development stage.
Benchmark specific technologies within the functional area to maintain state-of-the-art standards. Contribute to and drive strategic planning and accountability in technical development execution.
Mentor and guide scientific staff, providing support to new team members and serving as a resource for less experienced colleagues.
Ensure the execution of risk assessments and escalate issues to relevant bodies. Participate in the development of mitigation strategies.Lead the adherence to GxP / EHS / QA regulations.
Guarantee the GMP release testing and stability assessments of all investigational products, ensuring compliance with GMP requirements.
Participate in and lead the validation of analytical methods, facilitating the transfer of validated methods from the development group to commercial quality control or other partners.
Compose validation and transfer protocols and reports.Communicate effectively within Technical R&D and with external stakeholders, defending scientific and technical decisions at the appropriate governance levels.
Act as an ambassador for the department in various governance meetings.Basic Qualifications:
We seek professionals with the following essential qualifications:
Bachelor's degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
6+ years of experience in designing and executing scientific studies in support of technical programs and biopharmaceutical/vaccine development.
Proven experience in the analytical characterization of macromolecules, particularly polysaccharides and glycoproteins.Familiarity with Separation Science technologies (e.g., UHPLC, GC-FID/MS, Headspace-GC, LC-MS, capillary electrophoresis, and various testing protocols).
Experience in a GMP laboratory environment.
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 biopharmaceutical/vaccine initiatives.
Experience in method qualification and validation, alongside a solid understanding of QbD principles.Experience in data analysis automation and/or real-time release testing is a plus.
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 and technical decisions based on a balanced assessment of data and experience.
Innovatively solve complex problems through collaboration, offering fresh perspectives on existing solutions.
Demonstrated ability to work effectively within a dedicated team of scientists.
Communicate proficiently within Technical R&D and with external stakeholders, defending scientific and technical decisions at appropriate governance levels.
Possess the ability to influence scientific and technical vision and strategy.
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