Careers

Title: Associate Director/Director, Quality Control

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:

Associate Director/Director, Quality Control (QC) will lead QC activities for both drug substance and drug product.  This position is for a high level, experienced QC professional to serve as an analytical and QC subject matter expert.   The candidate must have deep and broad expertise in quality control, analytical chemistry, stability, and investigation. The candidate will leverage their direct QC and analytical experience to ensure the appropriate analytical method lifecycle management throughout lifecycle of development and commercial products. This is an individual contributor role in which the candidate represents QC function on multiple cross-functional project teams where he/she provides analytical/QC expertise, stability study management, associated regulatory support, and manage the QC aspects of the projects.  This requires significant internal collaboration as well as the management of analytical/QC activities conducted at external Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs).

Primary Responsibilities:

  • Apply knowledge and experience to ensure the appropriate analytical method lifecycle and QC management.
  • Provide technical guidance for troubleshooting / investigating complex issues regarding analytical, QC, stability, and process / product development.
  • Perform and lead method lifecycle management and analytical investigation activities (i.e. OOS, OOT) at external Contract Research Organizations (CROs) and contract manufacturing organization (CMO).
  • Apply statistical analysis for interpretation of analytical, QC, and stability data.
  • Review and approve certificate of analysis (i.e. raw material, components, API, DP)
  • Manage and improve critical material and reference standard management programs.
  • Manage and ensure on-schedule testing performance for drug substance, drug product, and in-use stability studies.
  • 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 release, in-process and stability specifications for APIs and drug products.
  • Manage and oversee QC, stability and analytical studies for projects.  This includes authoring / reviewing protocols and reports as well as evaluating the results (i.e. trending) 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 and QC 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) and CMOs.
  • Serve as a peer-leader to motivate / inspire colleagues and to mentor others in various aspects of QC, stability, and problem-solving methodologies.
  • Assist with responses to regulatory agencies regarding QC, stability and analytical-related inquiries.
  • Author and/or review relevant API and drug product CMC sections for global regulatory submissions (IND/IMPD, NDA/MAA, annual reports, and APQR/APR/PQR) 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.
  • Manage QC control charts and ensure continuous quality improvement in collaboration with stakeholders

Candidate requirements:

  • BS degree in analytical chemistry with 15+ years external QC management experience. MS or PhD degree in analytical chemistry with 10+ years pharmaceutical development and QC management experience
  • Analytical development and external QC management experience from development 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 NDA, APQR/APR/PQR
  • Demonstrates clear and succinct verbal and written communication skills
  • Familiar with FDA and EMA guidance documents relevant to small molecule pharmaceutical development
  • Strong knowledge and experience of quality management systems, stability program management, statistics, control charts, and data trending
  • Experience in commercial 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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