Vaxess Technologies · 2 weeks ago
Scientist/Senior Scientist, Analytical Development and Quality Control
Woburn, MA
Full-time
Onsite
Senior Level, Lead/Staff
$105K/yr - $145K/yr
10+ years expVaxess Technologies is developing innovative therapeutics using their novel micro-array patch platform. They are seeking a Senior Scientist with expertise in analytical methods, particularly HPLC and QC operations, to lead Quality Control testing and ensure compliance with cGMP requirements.
BiotechnologyHealth CareMedical
Hiring Manager
Sarah Coogan
Responsibilities
Lead the design, development, optimization, and execution of HPLC-based analytical methods (e.g., RP-HPLC, SEC, IEX) to support in-process, release, and stability testing
Develop, qualify, validate, and characterize GMP-compliant purity, SEC, and content methods for intermediates and drug products, with a strong emphasis on chromatographic workflows
Author and execute cGMP method qualification and validation protocols, prepare reports, and perform/oversee routine QC testing
Serve as Subject Matter Expert for chromatography methods during investigations of deviations, OOS/OOT events, assay failures, and other non-conformance issues
Provide technical leadership in HPLC troubleshooting, instrument maintenance coordination, data integrity practices, and chromatographic data review
Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions
Maintain rigorous laboratory documentation and complete, audit-ready analytical records
Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases
Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills
Qualification
Required
Ph.D. in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years (10 years for Senior Scientist) in the biotech/pharmaceutical industry; or M.S. with commensurate experience
Demonstrated in-depth expertise in HPLC, including method development, troubleshooting, system suitability design, chromatographic theory, and data interpretation
Hands-on experience with multiple chromatographic techniques (RP-HPLC, SEC, IEX, affinity, gradient optimization, detector setup/maintenance)
Proven success developing and validating GMP analytical methods and supporting GMP operations
Experience with complementary analytical techniques such as UV-Vis, LC-MS, CE, ELISA, or other functional assays is beneficial
Experience working in a QC or cGMP laboratory environment with strong understanding of data integrity requirements (ALCOA+)
Strong organizational skills, precision in documentation, and ability to manage multiple analytical workflows simultaneously
Excellent oral and written communication skills
Commitment to collaborative work within interdisciplinary project teams
Company
Vaxess Technologies
Vaxess Technologies engages in developing biomedical innovations with a focus on improving access to vaccines.
11-50 employees
H1B Sponsorship
Vaxess Technologies 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 (2)
2024 (1)
2022 (3)
Funding
Current Stage
Growth StageTotal Funding
$95.87MKey Investors
RA Capital ManagementNational Science FoundationThe Engine
2025-04-09Series Unknown· $9M
2024-05-22Series Unknown· $12M
2023-09-13Series Unknown· $9M
Leadership Team
K
Kathryn Kosuda
Co-founder, VP of Research & Development
Livio Valenti
Co-Founder, Senior VP of Strategy, BD and Operations
Recent News
EIN Presswire
2025-06-25
vcnewsdaily.com
2025-04-26
Company data provided by crunchbase