Title: Principal Scientist, Analytical Method Development

Location: Waltham, MA

Entasis Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including SUL-DUR (targeting A. baumannii infections) being evaluated in Phase 3 clinical trials, zoliflodacin (targeting Neisseria gonorrhoeae) being evaluated in Phase 3 clinical trials, and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections).

Position Description:

The principal scientist will lead analytical development activities for both drug substance and drug product across the Entasis development pipeline.  This position is for a high level, experienced analytical professional to serve as an analytical subject matter expert and point of contact for Entasis’s Pharmaceutical Sciences and CMC group.   The candidate must have deep and broad expertise in analytical chemistry in support of active pharmaceutical ingredient (API) and drug product development.  The candidate will leverage their direct analytical experience to ensure the appropriate analytical methodologies are in place and fit-for-purpose to properly support the development projects. This is an individual contributor role in which the candidate represents the analytical development team on multiple cross-functional project teams where they provide analytical expertise, associated regulatory support, and manage the analytical aspects of the projects.  This requires significant internal collaboration as well as the management of analytical activities conducted at external Contract Research Organizations (CROs).

Primary Responsibilities:

  • In support of product development, apply broad and deep analytical knowledge and experience to the material characterization and testing of APIs and drug products.
  • Apply knowledge and direct experience to ensure the appropriate analytical methodologies are in place and fit-for-purpose to properly support the development projects.
  • Provide technical guidance for troubleshooting / investigating complex issues regarding analytical, stability, and process / product development.
  • Perform and lead method development and analytical investigation activities in the lab
  • Leverage fundamental understanding of formulations, product development, and material characterization to implement analytical methodologies as appropriate for various formulations and dosage forms.
  • Apply statistical analysis for interpretation of analytical and stability data.
  • Manage and ensure on-schedule testing performance for development drug substance, drug product, and in-use stability studies to support clinical phase development programs.
  • Maintain stability business systems including but not limited to being the primary subject matter expert and trainer on stability procedures and guidance documents, and systems for archival and communication of stability study schedules and results.
  • Author and/or review analytical methods and associated development, qualification, validation and transfer protocols and reports.
  • Author and/or review release, in-process and stability specifications for APIs and drug products.
  • Manage and oversee stability and analytical studies for projects.  This includes authoring / reviewing protocols and reports as well as evaluating the results and leading technical discussions with project team members and external contractors.
  • Ensure all cGMP data generated for development projects are managed and evaluated as described in relevant internal procedures and regulatory requirements.
  • Quickly and effectively resolve complex analytical issues and deviations / investigations.
  • Effectively communicate complex technical issues and deliver concise presentations to management and non-technical stakeholders.
  • Actively contribute to the preparation and coordination of internal audits and regulatory inspections.
  • Provide technical input for selecting external contractors and manage day-to-day contractor activities for respective projects.
  • Create and enhance collaborative and trusting relationships internally and with personnel at Contract Research Organizations (CROs).
  • Serve as a peer-leader to motivate / inspire colleagues and to mentor others in various aspects of analytical and problem-solving methodologies.
  • Assist with responses to regulatory agencies regarding stability and analytical-related inquiries.
  • Author and/or review relevant API and drug product CMC sections for global regulatory submissions (IND/IMPD and NDA/MAA and annual reports) and ensure sections meet submission ready standards regarding content and format.
  • Maintain awareness of current trends regarding global regulatory CMC requirements through literature and conference attendance.
  • Actively contribute to the preparation and coordination of internal audits and regulatory inspections.
  • Ensure analytical test methods, development reports, and specifications are compliant with internal procedures and regulatory requirements.
  • Assist in the development and implementation of departmental processes, procedures and policies.
  • Maintain adherence to departmental and quality systems, such as SOP training records, deviations/investigations, CAPAs, and Change Controls.
  • Actively contribute to the preparation and coordination of internal audits and regulatory inspections.

Candidate requirements:

  • Advanced degree in analytical chemistry with 8+ years pharmaceutical development experience
  • Pharmaceutical development experience from preclinical through commercialization
  • Strong analytical, problem solving and critical thinking skills
  • Expertise with analytical method development, qualification and validation: experience with analytical techniques for small molecules including H(U)PLC, LC/MS, MSn, GC, IR, XRD, DSC, TGA, DVS, PSA is desired
  • Experience with startup pharmaceutical company and/or at least one product launch desired
  • Demonstrated experience authoring relevant sections of US and EU regulatory filings including IND, IMPD and NDA
  • Demonstrates clear and succinct verbal and written communication skills
  • Familiar with FDA and EMA guidance documents relevant to small molecule pharmaceutical development
  • Working knowledge of quality systems requirements.
  • Experience in cGMP manufacturing and testing
  • Excellent organizational skills with the ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities while maintaining attention to detail
  • Demonstrated leadership skills and the ability to collaborate with and effectively influence others. Prior experience managing functional teams and representing function in CMC teams

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