Seaport Therapeutics · 16 hours ago
Director, Analytical Research and Development CMC
Boston, MA
Full-time
Hybrid
Director/Executive
$198K/yr - $233K/yr
7+ years expSeaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines. They are hiring a Director, Analytical Research and Development, CMC to oversee the analytical method development and phase-appropriate validation of analytical methods for drug substance and drug product in pre-clinical and clinical development.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Oversee CDMO activites for drug substance and drug product analytical method development, validation and transfer for Seaport Therapeutics as assigned by the Senior Director of Analytical Research and Development
Represent the analytical CMC function at team meetings with CDMO’s and internal staff
Provide strategic oversight and day-to-day governance of assigned CDMO’s including project scope, adherence to timelines, quality, and integrity of data
Perform hands-on data review to ensure high-quality data reporting
Ensure compliance with regulatory standards, industry guidelines, internal SOPs applicable to the role
Support progress at CDMO’s via periodic onsite visits
Create and maintain release and stability databases gathered from CDMO stability reports
Work with ICH-compliant statistical stability software for stability data trending and shelf life predictions
Partner cross-functionally with Discovery, Program Teams, Regulatory Affairs, Quality Assurance to support data-driven decision-making and operational excellence at our partner CDMO’s
Advise CDMO’s on the analytical tools required to successfully complete method development and validation to industry standards
Plan and manage budgets, solicit quotes from vendors, create purchase orders and track spending
Qualification
Required
MS/Ph.D. in Analytical Chemistry or Physical Chemistry and 7+ years in early stage method development, method transfer, method validation for lipophilic drug substances and drug product
Demonstrated expertise in analytical development with complex drug substances and drug product formulations
Experience with drug product formulations utilizing SEDDS in soft-gelatin dosage forms
Demonstrated expertise in chromatographic techniques (for example: GC, LC, IC, GC, chiral separations,) employing the following (but not limited to) detectors: UV/vis, CAD, MS (SIM, MRM) fluorescence, FID, ECD
Experience with management of CDMO's for drug substance and drug product for multiple product lines
Knowledge of global regulatory requirements, ICH and other relevant guidelines
Proficiency in the use of Microsoft Office Suite products
Excellent communication, collaboration, and leadership skills
Comfortable with oversees travel approximately 25% of the time
Company
Seaport Therapeutics
Seaport Therapeutics operates as a clinical stage biopharmaceutical company.
51-200 employees
H1B Sponsorship
Seaport Therapeutics 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
2024 (1)
Funding
Current Stage
Growth StageTotal Funding
$325MKey Investors
General Atlantic
2024-10-21Series B· $225M
2024-04-09Series A· $100M
Leadership Team
Daphne Zohar
Founder, CEO & Board Member
Michael Chen
Co-founder, Chief Scientific Officer
Recent News
2026-01-05
2025-11-05
Company data provided by crunchbase