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Associate Scientist


McPherson, KS 67460
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Job Details


As a Sterile Injectable Growth R&D Pharm Sci. team member responsible for multiple projects, the Associate Scientist will conduct R&D activities to expand existing product lines into new global markets. He/she will independently perform chemistry, manufacturing, and controls gap assessments of existing dossiers and collaborate with cross functional teams to prepare remediation plans to address global regulatory requirements. The individual will design and execute studies according to remediation plans and assist the R&D Project Leader in guiding all CMC R&D development activities for product line extensions required for new global markets.

The Associate Scientist's responsibilities may include optimizing/developing current formulation and lyophilization cycles to meet global market requirements, developing methods, participating in remediation/verification/transfer, material qualification (excipients /active pharmaceutical ingredients) activities, and performing analysis required to support manufacturing functions (engineering, exhibit batches, etc), as well as on-going stability studies. The Associate Scientist will collaborate with other team members, manufacturing plants, and contract organizations as needed to achieve team goals and deliverables.


+ Has a good understanding of the disciplines beyond chemistry and pharmaceutical development.

+ Independently performs/oversees CMC (Chemistry, manufacturing and Controls) technical gap assessments. Develops plans and conducts studies to remediate gaps.

+ Assess, develops and validates analytical methods to support submission of existing product lines in new global markets.

+ Develops new formulations and manufacturing processes to support new configurations within existing product lines.

+ Plans and oversees registration batch manufacture and stability studies.

+ Writes protocols, reports, specifications, test methods, manufacturing documents, and documents for regulatory submission as needed.

+ Carries out all activities in compliance with applicable corporate requirements.


+ BS in Chemistry and at least 1 year of experience in the pharmaceutical industry

+ The individual should be able to operate and troubleshoot sophisticated analytical instrumentation while routinely ensuring that it is operating within required performance ranges. Must understand regulatory guidelines and have the ability to author protocols, reports and analytical test methods.

**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.

Last Day to Apply for Job: Feb 22, 2018

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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