Manager, Bioanalytical Operations and Development

Seaport Therapeutics • Boston, MA

39d • $133,000 - $157,000

About The Position

Seaport Therapeutics is a clinical-stage biopharmaceutical 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 seeking an experienced Manager of Bioanalytical Operations and Development to oversee the day-to-day execution and management of external bioanalytical studies to support small molecule and prodrug programs. This position is highly cross-functional, interfacing closely with CRO partners, internal scientists, Legal, Finance, and Contracting teams to ensure timely delivery of high-quality data and reports. The ideal candidate will demonstrate a commitment to fostering a collaborative and innovative culture that embodies our values of service by engaging in research that prioritizes the well-being of those impacted by mental health conditions, with a “we own it” mentality that exhibits an entrepreneurial mindset and dedication to scientific excellence, while increasing happiness and bringing out the best in each other “as a team”.

Requirements

• BS/MS degree with 5+ years of relevant experience in Bioanalytical development with strong emphasis on operational and document management
• Understanding of small molecule drug development and discovery processes and broad knowledge of assays to support global submissions desired
• Track record of leading small molecule development and validation of Bioanalytical LC-MS/MS methods designed at standards ranging from “fit-for-purpose” through GLP
• Experience with CROs and managing outsourcing studies required
• Knowledge of small molecule Bioanalytical regulatory guidelines and GLP/CGP regulations preferred
• Strong oral and written skills
• Ability to adapt to dynamic and fast-paced environment
• Ability to work cross-functionally, manage expectations and clearly communicate timelines
• Attention to detail is essential and excellent self-organizational and time management skills are required
• Strong computer skills with Microsoft Excel, Powerpoint, and Word are required; experience with SmartSheets and Prism preferred

Nice To Haves

• Study operations and/or study management experience is desired

Responsibilities

• Spearhead development of Bioanalytical methods (e.g. LC/MS) to assess concentration of API, metabolites, and related species across multiple small and large animal species
• Manage execution of method development, method validation, and sample analysis Bioanalytical studies across multiple external CROs and collaborators
• Manage internal contracting processes including procurement and legal collaboration for the execution of contracts and change orders, organizing and filing all contract documents
• Manage the logistics of sample tracking, reconciliation, and testing, including working with third-party labs
• Collaborate with cross-functional teams (e.g., discovery, development, regulatory) to align Bioanalytical activities with project goals
• Provide technical guidance/troubleshooting to ensure assays are being appropriately developed and methods are being executed accurately
• Review method development, validation, and Bioanalytical contributing reports to ensure accuracy and compliance
• Summarize studies in written reports, generate graphs/figures when appropriate and present data to discovery and development team/subteams

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees