AIChE CareerEngineer job board

Principal Scientist, Chemical Engineer for API Manufacturing Process Development

Spotlight Preferred
Pfizer
Groton, Connecticut, United States
11 days ago

Description

Why Patients Need You

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

ROLE SUMMARY

We are seeking an experienced chemical engineer to join the Chemical Research and Development (CRD) team in Groton. The successful candidate will join a diverse team responsible for developing robust scalable processes for use at pilot-plant and commercial scale. They will apply chemical engineering principles, computational modeling approaches, and lab-scale experimental techniques to gain process understanding and to optimize the processes for safety, efficiency, and robustness.

CRD, as part of Worldwide R&D in Pharmaceutical Sciences, is responsible for the development of process technology to manufacture active pharmaceutical ingredient’s (API). CRD scientists engage in all facets of development from small-scale synthesis in support of early phase clinical programs, to the development of the commercial synthetic route. CRD chemists and engineers collaborate with manufacturing specialists for API production 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, working closely with chemists and analysts, will lead the engineering activities to help identify optimal technology (batch, semi-batch, continuous) and process operating conditions. They will support technology transfer and scale up of the developed process in our pilot plant and commercial manufacturing facilities. Given the dynamic team environment and fast-paced project timelines, strong interpersonal and communication skills are essential. The candidate will also advance both computational tools and experimental techniques to enhance the group’s efficiency for developing future projects while gaining additional process insights.

The successful candidate will collaborate with the other senior members of the group to set medium- and long-term strategic goals related to development of new technology and workflows for improving the efficiency of CRD in developing API processes.  

ROLE RESPONSIBILITIES

  • Apply chemical engineering principles, computational modeling tools, and experimental skills using automated laboratory reactor system to develop robust unit operations and improve process understanding.
  • Apply an understanding of large-scale manufacturing equipment capabilities and operations to assess scalability and robustness for API processes.
  • Select, develop, and apply new process technologies to facilitate process design to achieve project goals.
  • Support technology transfer of processes to internal Pfizer Global Supply (PGS) API manufacturing facilities and external suppliers. May spend time at the PGS launch site supporting process validation and Pre-Approval Inspection (PAI) activities. 
  • Contributes to the preparation of the Chemistry and Manufacturing Controls (CMC) section of the New Drug Application (NDA).  Participate in data verification, PAI preparedness, and post submission query response.
  • Prepare internal research reports and technical presentations summarizing API process development activities to capture process knowledge and transfer process understanding to PGS. 
  • Champion the development of novel laboratory instrumentation and computational modeling tools to improve process understanding. Support the development and implementation of new and existing workflows and methodologies.
  • Working with team members with expertise in process modelling and in statistics, design and execute Design of Experiments (DoE) methodology using automated lab reactor systems. Use data from these experiments to understand reaction mechanisms, to build reaction kinetic models, and to understand the kinetic and thermodynamic factors impacting various separation unit operations such as extraction, distillation, crystallization, and drying.
  • Remain current with the process engineering and chemistry literature. May collaborate and author external publications and present research at external conferences.

BASIC QUALIFICATIONS

  • BS in Chemical Engineering with at least 12 years of experience, MS in Chemical Engineering with at least 8 years of experience, or PhD in Chemical Engineering with 2 - 5 years of relevant experience
  • Excellent knowledge of chemical engineering principles including reaction kinetics, reactor design, chemical thermodynamics, heat and mass transport, engineering statistics, process modeling and simulation.
  • Excellent interpersonal, teamwork, and communication skills

PREFERRED QUALIFICATIONS

  • Working knowledge of reaction modeling, property prediction, and simulation computational tools including: DynoChem, VisiMix, Aspen, M-Star, and COSMOtherm
  • Knowledge of Design-Expert or JMP for design and analysis of DoE studies 
  • Working knowledge of analytical techniques such as HPLC/UPLC, MS, PXRD, DSC, TGA, and NMR
  • Experience in automating laboratory equipment and processes including use of LabView
  • Experience using automated lab reactor systems such as EasyMax, RC1 or FlexyCube
  • Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, FBRM, UV/Vis
  • A good foundational understanding of organic chemistry
  • Experience in automating laboratory equipment and processes including use of LabView
  • Experience using automated lab reactor systems such as EasyMax, RC1 or FlexyCube
  • Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, FBRM, UV/Vis
  • A good foundational understanding of organic chemistry

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

  • Some travel associated with technology transfer to CRD pilot plant and PGS new product launch site may be required. 

OTHER INFORMATION

  • Last Date to Apply: September 28, 2021
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus
  • #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.

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#LI-PFE



Job Information

  • Job ID: 58685650
  • Location:
    Groton, Connecticut, United States
  • Position Title: Principal Scientist, Chemical Engineer for API Manufacturing Process Development
  • Company Name: Pfizer
  • Industry: Chemical
  • Job Function: Engineering

Please refer to the company's website or job descriptions to learn more about them.

View Full Profile

Jobs You May Like