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Seaport Therapeutics · 1 month ago

Manager, Bioanalytical Operations and Development

Boston, MA

Full-time

Onsite

Mid, Senior Level

$133K/yr - $157K/yr

5+ years exp

Seaport Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel neuropsychiatric medicines. The Manager of Bioanalytical Operations and Development will oversee the execution and management of external bioanalytical studies, collaborating with various teams to ensure timely delivery of high-quality data and reports.

BiotechnologyPharmaceuticalTherapeutics

H1B Sponsor Likely

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

Qualification

Bioanalytical method developmentLC-MS/MSSmall molecule drug developmentCRO managementRegulatory guidelines knowledgeOralSelf-organization skillsMicrosoft ExcelMicrosoft PowerPointMicrosoft WordSmartSheets experiencePrism experienceWritten skillsAttention to detailTime management skills

Required

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

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

Preferred

Knowledge of small molecule Bioanalytical regulatory guidelines and GLP/CGP regulations preferred

Study operations and/or study management experience is desired

Experience with SmartSheets and Prism preferred

Company

Seaport Therapeutics

Seaport Therapeutics operates as a clinical stage biopharmaceutical company.

Founded in 2024

Boston, Massachusetts, USA

51-200 employees

https://seaporttx.com/

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)