Advantage Technical ยท 22 hours ago
Senior Associate Scientist
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
$50/hr - $50/hr
2+ years expAdvantage Technical is seeking a Senior Associate Scientist to provide specification support for siRNA drug substances and products. This role involves managing specification lifecycle management and ensuring compliance within a cGMP environment.
Staffing & Recruiting
Hiring Manager
Damarys Zambrano, MSIOP
Responsibilities
Initiate, manage, and support specification change controls in a cGMP environment
Perform specification assessments for existing products and new molecules in development
Maintain platform-level and program-specific specification documents
Review analytical and stability data to ensure accuracy, compliance, and on-time delivery
Author and review SOPs, protocols, and other controlled documents in accordance with company and regulatory requirements
Contribute to analytical and stability sections of regulatory submissions
Support responses to regulatory agency questions and information requests
Provide technical support and subject matter expertise to cross-functional teams
Participate in general laboratory and operational activities as required
Define, implement, and maintain specifications supporting development and clinical programs
Ensure compliant review and verification of stability data to support clinical supply
Support implementation of stability and release specifications for product registration
Maintain adherence to company quality standards and core values
Qualification
Required
BS or MS in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline
Minimum of 2 years of experience in a cGMP analytical laboratory environment
Strong understanding of chemistry principles applicable to drug substance and drug product development
Experience reviewing and authoring technical data and documentation
Strong written and verbal communication skills, including technical writing and presentations
Ability to work independently while collaborating effectively in cross-functional teams
Demonstrated attention to detail and strong organizational skills
Preferred
Experience supporting QA, QC, or Regulatory functions
Experience conducting or supporting stability studies in accordance with ICH guidelines
Hands-on experience with HPLC and physico-chemical test methods, preferably for oligonucleotides
Experience with oligosaccharides or proteins is also acceptable
Familiarity with Veeva and data processing systems
Experience with statistical analysis and data trending
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
H1B Sponsorship
Advantage Technical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (7)
2021 (10)
2020 (48)
Funding
Current Stage
Late StageCompany data provided by crunchbase