Director, Analytical Research and Development CMC

Seaport Therapeutics•Boston, MA

4d•$198,000 - $233,000•Onsite

About The Position

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com. Seaport Therapeutics is 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. This role reports to the Senior Director, Analytical Research and Development, CMC. In the near term, the role will focus on method development and validation of Phase 1 Phase 2 and early Phase 3 drug substance and drug product candidates. The role will assist with preparation and review of CMC Regulatory filings. This person will coordinate activities at various CDMO’s to achieve company objectives related to the analytical contribution of process and product development. The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston’s Seaport area, with a strong preference for being onsite 4 days per week. Up to 25% travel to CDMO sites will be required.

Requirements

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.

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.