Senior Scientist Analytical Development Lead
3 weeks ago
Job Summary:
We are seeking a highly skilled Senior Scientist Analytical Development Lead to join our team at Cedent Consulting Inc. The ideal candidate will have a strong background in analytical development and a proven track record of leading cross-functional teams.
Key Responsibilities:
* Partner with Analytical Development groups to achieve commercial method readiness using traditional and advanced analytical techniques.
* Participate in cross-functional, multi-site global meetings and projects, overseeing commercial analytical method transfer between sites, product/process investigations, method performance monitoring, and troubleshooting.
* Establish scientifically sound analytical lifecycle strategies, including methods, stability, specification, and change management, that meet Health Authority best practices and expectations.
* Participate in the preparation and review of technical documents to ensure global compliance, including validation protocols and reports, reference standard qualification reports, and analytical test procedures.
* Author regulatory submissions, support regulatory inspections, and provide scientifically sound responses to agency deficiency letters.
* Conduct periodic review of methods and work with program leads to design, execute remediation experiments, and implement changes to new or existing commercial methods when necessary.
Requirements:
* PhD in Chemistry, Biochemistry, Biological Sciences, or related scientific disciplines with 2 years of relevant experience or MS/BS with 9-12 years of relevant experience.
* Proven experience in method development, qualification, validation, and method transfer in support of development and/or commercialization of biological products.
* Experience with methods such as HPLC/UPLC, capillary electrophoresis, and spectrophotometric techniques.
* Ability to lead and manage projects/teams of significant scope and complexity while meeting all deliverables and timelines.
* Demonstrated critical thinking, troubleshooting, and problem-solving skills.
About Us:
Cedent Consulting Inc is a leading consulting firm specializing in biologics product development and commercialization. We are committed to delivering high-quality solutions to our clients and are seeking talented professionals to join our team.
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