Apex Systems
Scientist, Analytical Development
Apex Systems, Waltham, Massachusetts, United States, 02254
Job#: 2043785Job Description:Scientist, Analytical Development 2043785Location:
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, collaborating with teams and mitigating risks.Validate analytical methods following regulatory guidelines for accuracy and precision.Ensure analytical activities comply with regulatory standards and prepare submissions.Manage timelines, resources, and budgets for projects, reporting progress to management.Primary Job Requirements:PhD, M.Sc, or B.Sc in analytical chemistry, polymer science, biochemistry, or biotechnology, coupled with relevant industry experience in Pharma/Biotech. Skilled in GMP analytical method development for biologic product quality control.Proficient in various analytical instruments and familiar with regulatory compliance.Strong analytical and communication skills, with proficiency in statistical software.
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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, collaborating with teams and mitigating risks.Validate analytical methods following regulatory guidelines for accuracy and precision.Ensure analytical activities comply with regulatory standards and prepare submissions.Manage timelines, resources, and budgets for projects, reporting progress to management.Primary Job Requirements:PhD, M.Sc, or B.Sc in analytical chemistry, polymer science, biochemistry, or biotechnology, coupled with relevant industry experience in Pharma/Biotech. Skilled in GMP analytical method development for biologic product quality control.Proficient in various analytical instruments and familiar with regulatory compliance.Strong analytical and communication skills, with proficiency in statistical software.
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