Pfizer

Senior Scientist, Crystallization Process Development

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Posted
November 16 2020
Ref
4785818
Position Type
Full Time
Organization Type
Pharma
Job Type
Senior Scientist
ROLE SUMMARY

We are seeking a senior scientist to join the Crystallization Technology Laboratory as part of Chemical Research and Development (CRD) team in Groton. The successful candidate will be responsible for designing and developing robust scalable Active Pharmaceutical Ingredient (API) crystallization 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 medicinal chemistry 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 will support API project teams in crystallization process design and development, technology transfer, and regulatory filing activities for new small molecule candidates. They will work closely with process chemistry, materials science, and drug product development colleagues to identify and optimize API target attributes. They will develop technology for clinical projects to deliver API that meets the targeted physical and chemical quality attributes by applying knowledge of crystallization and solid form science. Working as part of multidisciplinary teams, the scientist will develop robust and scalable processes suitable for transfer to a commercial manufacturing facility. The candidate will also improve capabilities of the group through the development and advancement of new technologies related to crystallization process development such as sono-crystallization, continuous crystallization, and integrated process control. They will develop and utilize computational models such as thermodynamic predictions, solid form modelling, and population balance models to facilitate design of crystallization processes. Given the dynamic team environment and fast-paced project timelines, strong interpersonal and communication skills are essential.

ROLE RESPONSIBILITIES
  • Apply crystallization process design and development fundamentals, modeling tools, and experimental skills using data-rich laboratory instrumentation to develop robust crystallization processes for API and intermediates.
  • Work at the interface with Drug Product Design, Material Sciences, Process Chemistry and Analytical Research and Development colleagues to identify the API target attribute profile and API impurity control strategy.
  • Select, develop, and apply new and existing process technologies to facilitate process design to achieve project goals.
  • Support technology transfer of drug substance processes to internal Pfizer 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). Participates in data verification, PAI preparedness, and post submission query response. Collaborate and prepare internal research reports and technical presentation.
  • Champion the development of novel laboratory instrumentation and software modeling tools to improve process understanding. Leads the development and implementation of new and existing workflows and methodologies.
  • Remain current with the process engineering and chemistry literature. May collaborate and author external publications and present research at external conferences.


BASIC QUALIFICATIONS
  • MS in Chemical Engineering or Chemistry with 2-5 years of experience or PhD in Chemical Engineering or Chemistry with 0-4 years of relevant experience required
  • Detailed knowledge of chemistry and chemical engineering principles related to crystallization and isolation unit operations
  • Excellent interpersonal and communication skills


PREFERRED QUALIFICATIONS
  • Working knowledge of distillation, solubility, crystallization, and filtration predictive tools
  • Experience with computational modelling tools such as ASPEN, Materials Studio, and DynoChem, Visimix, and COSMOTherm
  • Working knowledge of UPLC, PXRD, NMR, DSC and TGA, and microscopy.
  • Knowledge of Design Expert or JMP
  • Working knowledge and application of MatLab
  • Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, FBRM, UV/Vis, Raman
  • 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.

Other Details:

Eligible for Relocation: YES

Eligible for Employee Referral: YES

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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.

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