Title: Director, Analytical Method Development, CMC
Location: Waltham, MA
Entasis Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel antibacterial products to treat urgent and serious infections as prioritized by the CDC and WHO. The innovative and robust pipeline include two late-stage programs against highest-priority pathogens - sulbactam-durlobactam (SUL-DUR) (targeting A. baumannii infections), which has completed phase III and zoliflodacin (targeting Neisseria gonorrhoeae) that is nearing phase III completion. Three additional programs in early-stage development include ETX0462 against Pseudomonas aeruginosa, ETX0282CPDP against MDR cUTIs, and NBP2 for Gram (-) infections.
The director/Sr. director 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. The successful candidate will represent 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. In addition, this individual will lead and manage analytical development and testing activities with external partners. The incumbent will lead and oversee planning and execution of development, tech transfer, testing and validation with external development and manufacturing partners. The position requires enthusiasm, passion, and attention to detail. This requires significant internal collaboration as well as the management of analytical activities conducted at external Contract Research Organizations (CROs) and contract manufacturing organizations (CMOs). The Director/Sr. director will represent Analytical Development-CMC during meetings involving various Entasis functions such as Regulatory Affairs, Quality Assurance, Technical Operations, and R&D management.
- Provides strategy oversight, direction, and leadership to the analytical, method, and testing aspects for Entasis product portfolio
- Manages external CMOs and analytical/QC testing vendors
- Provide oversight on analytical testing, method transfer, method validation, and control on raw material, in-process, DS/DP release and stability studies
- Maintains high standards of quality and regulatory compliance
- Provides statistical analysis of analytical results to support stability assessments
- Prepares and reviews relevant analytical CMC sections of drug substance and drug product regulatory submission (INDs, IMPD, Briefing Documents)
- Interacts with US and/or EU Regulatory as it relates to questions regarding analytical development and CMC
- 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.
- 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.
- 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.
- 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.
- Advanced degree in analytical chemistry with 12+ years pharmaceutical development experience
- Pharmaceutical development experience from preclinical through commercialization
- Strong analytical, problem solving and critical thinking skills
- Direct experience with the analytical support of synthetic APIs and drug products
- Expertise with analytical method development 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 start-up 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
- Strong knowledge of ICH and other regulatory guidelines such as FDA and EMA guidance documents relevant to small molecule pharmaceutical development
- Strong 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
- Exercises independent judgment to determine most appropriate course of action including technique, method selection, protocol, study design and execution, in-depth data analysis, multi-factor evaluation and use of established practices and procedures for a variety of problems of broad scope and complexity, in alignment with organizational objectives
- Exemplifies and champions critical thinking in identifying and implementing highly innovative and effective solutions and strategies and leveraging established practices and procedures for a broad range of problems of diverse scope and complexity to sustain company products, objectives, and priorities
- Presents challenging issues and results at department and cross-functional gatherings, and project team meetings
Entasis is proud to be named one of the BEST workplaces in HealthCare and Biopharma by the Great Place to Work Institute and Fortune Magazine! https://www.greatplacetowork.com/certified-company/7022538
Entasis offers a comprehensive benefits package to all eligible employees including health, dental, vision, 401(k), Health Savings Account, Employee Assistance Program, Short/Long Term Disability Insurance, and Paid Time Off.
Entasis is an equal opportunity workplace and participates in E-Verify. We welcome diversity and are committed to creating an inclusive environment for all employees. All employment is decided on the basis of qualifications, merit, and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status or any other status protected by law.
Entasis considers the health and safety of it’s employees and community a top priority. To be employed by Entasis you will be required to be fully vaccinated or to have met the legal criteria for a reasonable accommodation. If you have any questions or concerns, please discuss them with your recruiter during the application/interview process.