Associate Director, Drug Substance Process Development and Manufacturing We are seeking an Associate Director, Drug Substance Process Development and Manufacturing to join the Technical Operations team.
The ideal candidate will have a strong background in process chemistry and manufacturing of small molecule drug substances. In this role, he/she will lead research development activities and oversee manufacturing at contract organizations to ensure sufficient supply for tox and clinical studies, work closely with Quality, Analytical, Regulatory, and Clinical Supply, provide phase appropriate solutions to meet the program objectives. Key responsibilities include process design, scale-up, and technology transfer in collaboration with Quality and Analytical Services. This role reports to the Sr. Director, API Development and Manufacturing.
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.
Responsibilities: Lead the design, planning, and execution of multi-step organic syntheses of small molecule drug substancesEnsure synthetic route, pharmaceutical form, and compound properties are appropriate for kilo lab and plant manufacturingConduct scenario planning to provide analysis and recommendations on development strategy along with associated assumptions and risksIdentify and track critical process parameters throughout process and manufacturing development to adequately characterize and measure process/product performance and key quality attributes.Lead Tech-Transfer and validation activitiesProactively work to manage vendors with regard to scope, timelines, and deliverablesProvide on-site support to CDMO as necessaryPresent technical data to cross functional teams and senior management as neededCollaborate with Quality on investigation of events and resolve them in a timely mannerServe as SME in preparation of briefing book, IND/IMPD and NDA applicationsQualifications: Degree in chemistry or chemical engineering with experience in pharmaceutical industry, advanced degree preferred:BS with 12+ years of experienceMS. with 10+ years of experiencePhD with 8+ years of experienceIn depth knowledge in synthetic route development and process optimizationExperience with technology transfer and outsourced work on process developmentWorking knowledge of the appropriate analytical techniques such as HPLC, LCMS, NMR etc.Experience in API manufacturing associated with small molecules in different phases of clinical developmentFirm knowledge of regulatory guidance applicable to small molecule drug substanceAbility to work in a complex, dynamic, global environment; thinking strategically and balancing both long and short-term prioritiesAbility to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skillsAbility and willingness to work 50% in office and travel up to 20% globally
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