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Senior Scientist, Analytical R&D, Biologics


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Job Details

The qualified candidate will join the Analytical R&D organization to enable development of biological therapeutics in Chesterfield, MO. The qualified candidate will be responsible for review and analyses of analytical data in order to assess product quality, biological activity, detection of impurities, characterization and product stability. This group performs testing in the R&D and/or regulated settings in support of clinical drug candidates. The group also supports method development, transfer, verification, qualification and validation as well as troubleshooting.


+ The qualified colleague is responsible for establishing and overseeing stability programs for multiple large molecule projects in order to enable clinical studies in a GMP environment.

+ The individual is responsible for assessing results in a breadth of analytical methodologies including Compendial test methods, HPLC, electrophoresis, residual DNA using qPCR, and ELISA in order to be able to assess the stability of various large molecule modalities.

+ The qualified colleague will also be responsible for authoring the stability assessment in regulatory filing applications.

+ The colleague must work within corporate guidelines and must appropriately record, archive and report all data. The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team across multiple geographies.

+ **Note: There is no laboratory work as a part of this position.**


+ BS in chemistry, analytical chemistry, biochemistry, biology

+ Minimum of five years of laboratory experience in a variety of large molecule and vaccine analytical techniques including experience with qPCR analysis.

+ Ability to follow established procedures under minimal supervision.

+ Experience with assessment of analytical data for underwriting the stability expiry for biological materials.

+ The candidate must thrive in a fast-paced environment

+ Attention to detail, strong organizational skills, the ability to multitask and effective interpersonal, influencing skills and communication skills are required


+ Experience with Quality Systems in a GMP environment

+ Experience with assessment of large molecule stability data and authoring of regulatory filing documents

+ Some knowledge of drug development process for progression of biological candidates

+ Experience with qPCR analysis and analytical testing of gene therapy therapeutics would be an advantage

**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.

**Other Job Details:**

+ **Last Date to Apply for Job: April 11, 2018**

+ Additional Location Information: Chesterfield MO, Groton CT, Andover MA, Pearl River NY, North Carolina (remote)

+ Eligible for Employee Referral Bonus

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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