Senior Chemical Engineer for Continuous API Development and Manufacturing
Posted on: June 13, 2021
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
- 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
- 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
- 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
- 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)
- Applies chemical engineering skills and specific process
knowledge to understand and resolve scale-up issues during
- Contributes to the preparation of the New Drug
- 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
- May collaborate and author external publications and present
research at external conferences.
- 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
Required Technical Skills
- A good understanding of organic chemistry and chemical
- 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.
- 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
- 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
Other Job Details:
- Eligible for Relocation Package: YES
- Eligible for Employee Referral Bonus: YES
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.
EEO & Employment Eligibility
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
Keywords: Pfizer, Newton , Senior Chemical Engineer for Continuous API Development and Manufacturing, Other , Groton, Massachusetts
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