Scientist, Analytical Development

Company: Principia Biopharma Inc.
Location: Framingham
Posted on: June 1, 2021

Job Description:

Position Overview:

This position resides within the Analytical Development group, part of the Global Biologics CMC Development organization at Sanofi, Framingham, MA. The Analytical Development group has the overall responsibility to develop, qualify and validate robust analytical methods to support release and characterization testing of protein candidates in early stage development (Phase I/II). The Analytical Development group also performs cGMP sample testing for the purpose of drug substance and drug product lot release and stability testing.

We are looking for a skilled, highly motivated individual with expertise in physicochemical method development who works well in a team-setting to meet project goals within the established timelines. In addition to mentoring and training junior analysts, a significant part of this role consists of performing hands-on laboratory activities as an individual contributor. The ideal candidate is expected to have a solid background in separation science, especially in capillary electrophoresis (CE-SDS, cIEF) and HPLC, with extensive experience in protein characterization.

Key Responsibilities:

* Develop, qualify, and validate cGMP analytical methods for the characterization, release and stability testing.

* Focus on various separation science platforms such as electrophoresis (CE-SDS, CIEF) and HPLC (SEC, IEX, RP) using a variety of detection modes. In addition, the individual may support other physicochemical analytical methodologies and compendial testing depending on project needs.

* Write and review method procedures, assay qualification and validation plans/reports and ensuring that the documents adhere to GxP requirements and ICH guidelines.

* Mentor junior analysts to ensure timely completion of assignments with full data integrity. Providing guidance and mentorship to help junior staff nurture their career growth.

* Maintain a GMP compliant laboratory environment. Serving as a technical resource to solve analytical method and instrument issues.

* Interface with CMC program management team and 3rd party contract laboratories.

Qualifications and Skills:

* Ph.D. in Biochemistry, Analytical Chemistry or related discipline or a Master's degree with a minimum of 4 years of relevant industry experience or a Bachelor's degree with a minimum of 6 years of relevant industry experience.

* Expertise in analytical protein separation techniques (CE and HPLC) is required. Familiar with a variety of bioanalytical assays such as cell based assays, binding assays, and mass spectrometry-based assays is a plus.

* A fundamental knowledge of cGMP compliance requirements and excellent organizational skills. Proven ability to adhere to good documentation standards and maintain detailed records of all work performed.

* Proven capability of evaluating/developing new technologies in an independent manner and be able to propose/design implementation strategies if deemed appropriate (e.g. method comparability approaches).

* A strong ability to work both independently or in cross-functional teams and an ability to meet timelines efficiently and productively.

* Proven ability to work with a high level of integrity, accuracy, and attention to detail.

Preferred Qualifications

* Hand on experience in multiple analytical technologies for the characterization of biologics such as mAbs or fusion proteins.

* Direct experience with assay method development, qualification and validation is a plus.

* Experience with and/or knowledge of the regulatory requirements for early stage biologics development including knowledge of appropriate control and testing strategies.

* Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) will be considered an advantage.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Keywords: Principia Biopharma Inc., Framingham , Scientist, Analytical Development, Other , Framingham, Massachusetts