Director, Analytical Research and Development CMC at Seaport Therapeutics

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 May, 26

Salary

233000.0

Posted On

02 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Chemistry, Method Development, Method Validation, Drug Substance, Drug Product, Chromatographic Techniques, Regulatory Compliance, Data Review, Project Management, Collaboration, Leadership, Statistical Software, CDMO Management, Communication, Quality Assurance, Entrepreneurial Spirit

Industry

Biotechnology Research

Description

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. Key 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. Qualifications 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. At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $198,000-233,000, with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

Responsibilities

Oversee analytical method development and validation for drug substance and drug product in pre-clinical and clinical development. Coordinate activities at various CDMOs to achieve company objectives related to analytical contributions.