Senior Chemical Engineer for Continuous API Development and

Company: Pfizer
Location: Groton
Posted on: April 8, 2021

Job Description:

Senior Chemical Engineer for Continuous API Development and Manufacturing We are seeking a highly collaborative chemical engineer with continuous processing knowledge to join Chemical Research and Development (CRD) in Groton. The successful candidate will support the development of Pfizer's strategy to deliver continuous development and manufacturing approaches to active pharmaceutical ingredient (API) candidates in our portfolio. They will collaborate and partner with others to help us establish a suite of continuous technologies with proven application to enhance speed, quality and flexibility in API development and manufacturing from early candidate selection through to commercial application. CRD, as part of Worldwide R&D in Pharmaceutical Sciences, is responsible for the development of process technology for the production of API. CRD scientists engage in all facets of development from small scale synthesis in support of medicinal chemistry programs, to the development of the commercial synthetic route. CRD scientists partner with manufacturing specialists for API synthesis in kilo-lab and pilot plant facilities, as well as provide support for technology transfer to Pfizer manufacturing sites and third party facilities. The successful candidate will join the Technology API group as a laboratory-based experimentalist.-- They will provide chemical engineering expertise for the development of continuous API platforms, workflows and processes. They will partner with chemists, analysts, mechanical engineers and chemical engineers from across Pfizer R&D and manufacturing organizations to assess existing continuous API platforms and design novel continuous API platforms for selected unit operations. They will prototype continuous API platforms through laboratory and plant application and progress successful platforms to modular and industry standardized units for manufacturing implementation.-- They will support the development of platforms and workflows to enable the delivery of integrated continuous unit operations for API development and manufacture, ensuring strong partnership with experts in PAT, automation and control. The ability to work on multi-disciplinary teams involving chemists, analysts, engineers, and technologists, and to represent CRD on cross-functional teams is essential. ROLE RESPONSIBILITIES

• Bring prior knowledge of the concepts of API continuous development and manufacturing to develop continuous API platforms, workflows and processes.
• Connect, co-operate and partner with chemists, analysts, mechanical engineers and chemical engineers from across Pfizer R&D and manufacturing organizations to assess existing continuous API platforms and design novel continuous API platforms for selected unit operations.
• Prototype continuous API platforms in the laboratory and Kilo Laboratory in Groton and enable for Pilot Plant and commercial manufacturing through the development of modular and industry standardized units.
• Apply chemical engineering principles and models (reaction kinetics, thermodynamics, heat and mass transfer, and mixing effects) to evaluate and develop scalable and robust processes for the manufacture of API using continuous technologies.
• Partner with experts in process analytical technology, automation and control to enable the delivery of integrated continuous unit operations for API development and manufacture.
• Working in a modern automated laboratory, performs laboratory experiments to develop process understanding using a One Factor at a Time (OFAT) and/or a Design of Experiments (DoE) methodology as appropriate.--
• Performs experiments to understand reaction mechanisms and kinetics, stability, solvent exchange, etc.
• Support technology transfer of API processes to internal Pfizer API manufacturing facilities and external suppliers.
• May spend significant time at the PGS launch site supporting process validation and Pre-Approval Inspection (PAI) activities.--
• Applies chemical engineering skills and specific process knowledge to understand and resolve scale-up issues during transfer.
• Contributes to the preparation of the New Drug Application.--
• Participates in data verification, Pre-Approval Inspection preparedness, and post submission query response.
• Remains current with the process engineering and chemistry literature. Collaborates and prepares internal research reports and technical presentations.
• May collaborate and author external publications and present research at external conferences. QUALIFICATIONS Required Education/Experience
  • BS/MS Chemical Engineering with a minimum of 5 years relevant chemical or pharmaceutical continuous platform and process development experience or PhD in Chemical Engineering.--
  • For a BS or MS engineer, the following experience is preferred; developing, scaling and transferring flow technologies; working in a fine chemical or API manufacturing facility with a good knowledge of continuous unit operations, and developing and applying modelling tools. Required Technical Skills
    • A good understanding of organic chemistry and chemical engineering principles.
    • A good understanding of fundamental principles of continuous processing from a laboratory and manufacturing perspective.
    • Familiarity with in-situ analytical tools (e.g FTIR, FBRM, and UV/Vis) and common analytical chemistry instrumentation including UPLC, HPLC, and MS. Preferred Technical Skills
      • A working knowledge of organic and/or physical organic chemistry and chemical engineering principles.--
      • A working knowledge of reaction modeling, material property prediction, and simulation using computational tools including: DynoChem, gPROMS, Visimix, Aspen, Fluent, and Cosmotherm.--
      • Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, FBRM, and UV/Vis.--
      • Working knowledge of UPLC, MS, and NMR spectroscopy.
      • Experience with tools such as MatLab or LabVIEW and development of automation platforms. PHYSICAL/MENTAL REQUIREMENTS
        • Ability to work in a laboratory environment performing experiments in a laboratory fume hood.
        • Ability to perform complex data analysis. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
          • Will be required to occasionally travel internationally (0-10%) to support technology development and/or clinical manufacturing activities as well as technology transfer to commercial manufacturing. Other Job Details:
            • Eligible for Relocation Package: YES
            • Eligible for Employee Referral Bonus: YES #LI-PFE Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Research and Development Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Keywords: Pfizer, Newton , Senior Chemical Engineer for Continuous API Development and, Engineering , Groton, Massachusetts