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Senior Scientist, Process Development


Groton, CT
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Job Details

Support Active Pharmaceutical Ingredient (API) project teams with crystallization process development, technology transfer, and regulatory filing activities for new small molecule candidates. Work closely with process chemistry, analytical chemistry, materials science, and drug product development colleagues to identify API target attribute profile. Develop technology for clinical projects to deliver API that meets the target attribute profile using crystallization workflows with an end goal of delivering robust and scalable processes. Improve capabilities of the group through the development and advancement of new technologies related to crystallization process development such as molecular modelling, methods for measuring crystallization kinetics, continuous crystallization, integrated process control, or incorporation of population balance models. This position is in the department of Chemical and Research Development (CRD) and the work location is in Groton, CT. Some travel associated with technology transfer to CRD pilot plant and Pfizer Global Supply (PGS) new product launch site may be required.

**Role Responsibilities**

+ Apply crystallization process development fundamentals, modeling tools, and experimental skills to develop robust crystallization processes for API and intermediates.

+ Work at the interface with Drug Product Design 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.

+ Supports 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.



+ MS in Chemistry or Chemical Engineering with 2-5 years of experience or PhD in Chemistry or Chemical Engineering with 0-4 years of relevant experience

Required Skills:

+ Detailed knowledge of chemistry and chemical engineering principles related to crystallization and isolation unit operations.

Preferred Skills:

+ Working knowledge of distillation, solubility, crystallization, and filtration predictive tools

+ Working knowledge of UPLC, PXRD, NMR, and Microscopy

+ Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, FBRM, UV/Vis

+ A good foundational understanding of organic chemistry

**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.

**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.

**Additional Offer Details:**

+ Last Date to Apply for Job: November 14, 2017

+ This job is Pfizer Exempt US/PR Grade: 008

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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