Title: Director, Process Chemistry, 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 the API process development team across the Entasis development pipeline. We are seeking a pharmaceutical chemical process development professional to develop cost effective, safe, robust, and compliant chemical manufacturing processes to enable the preparation of high-quality drug substance for evaluation in early to late-stage clinical development and commercial supply. The successful candidate will represent the API process development team on multiple cross-functional project teams where they provide chemical process development expertise, associated regulatory support, and manage the API process aspects of the projects. In addition, this individual will lead and manage API process development and lifecycle management activities with external partners. The incumbent will lead and oversee planning and execution of development, tech transfer, and process 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 manufacturing activities conducted at external contract manufacturing organizations (CMOs). The Director/Sr. director will represent API process development-CMC during meetings involving various Entasis functions such as Regulatory Affairs, Quality Assurance, Technical Operations, and R&D management.
- Lead the RSM, API process research, development, and commercial RSM/API process lifecycle management activities
- Develop and execute strategies for cost effective, safe, robust, and compliant chemical manufacturing processes to enable the preparation of high-quality drug substance for evaluation in early to late-stage clinical development and commercial supply
- Provide oversight of CMOs on RSM/API tech transfer, process development, process validation, and routine manufacturing activities
- Support NOR/PAR studies, pre-validation, and validation activities for drug substances
- Review of batch records, testing results, and specifications in compliance with cGMP
- Author process development reports and document all development activities in preparation of regulatory filings
- Maintains high standards of quality and regulatory compliance
- Prepares and reviews relevant CMC sections of drug substance regulatory submission (INDs, IMPD, Briefing Documents)
- Interacts with US and/or EU Regulatory as it relates to questions regarding API process development, CMC
- Provide technical guidance for troubleshooting / investigating complex issues regarding API processes, analytical, stability, and product development
- Manage and ensure on-schedule API delivery to support clinical phase development programs
- Author and/or review release, in-process and stability specifications for RSM and APIs
- 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 process 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 CMOs
- Assist with responses to regulatory agencies regarding API process inquiries
- Author and/or review relevant API 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
- Assist/lead 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 and mentor direct reports
The idea candidate will have the following qualifications:
- PhD in organic/process chemistry with 15 years of experience in organic/process chemistry in the pharmaceutical field, working on projects from pre-clinical to commercial phase with a minimum of 15 years’ experience working in a GMP environment
- Experience working in a virtual CMC company environment with external manufacturers/CMOs
- Extensive knowledge of fundamental process chemistry concepts, including, but not limited to: organic chemistry, reaction mechanisms, crystallization, kinetics, thermodynamics, fluid mixing and heat transfer
- Excellent understanding of FDA, EMA and ICH guidance documents and the ability to apply sound regulatory strategies to process chemistry problems
- Experience inventing, troubleshooting and optimizing organic chemistry processes from gram to multi-kilogram scale
- Knowledgeable about the available analytical techniques required for raw material, in-process and release of pharmaceutical compounds
- Solid knowledge of quality assurance regulations
- Experienced in the identification and control of impurities in a manner consistent with existing regulatory guidance
- Experience reviewing, correcting and approving GMP manufacturing batch records
- Experience working with multi-functional teams including, but not limited to: formulation development, analytical development, material management, non-clinical, clinical personnel
- Excellent written, oral and document control skills
- Experience auditing potential GMP drug substance manufacturers.
- Experience in technical writing, including but not limited to, process development reports and characterization reports.
- Experience with regulatory writing such as INDs, IMPDs, and FDA briefing documents; NDA writing a plus
- Experience with drug substance validation and design of experiments a plus
- Experience with commercial drug substance lifecycle management a plus
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.