Head of Analytical Development, Quality Control, Genomics Medicine & Chemical Manufacturing

Company: Principia Biopharma Inc.
Location: Framingham
Posted on: June 7, 2021

Job Description:

This position resides within the newly established Genomic Medicine Unit (GMU) which is part of Sanofi's CMC Development organization. The GMU Analytical Development group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different gene therapy candidates. In addition, the group supports cGMP-compliant release and stability testing of clinical supplies performing both the product-specific as well as compendial methods.

We are looking for a skilled and highly motivated leader with broad expertise in physicochemical method development to join the GMU Analytical Development group in Framingham MA. The selected candidate will establish and manage a team of scientists and research associates who are tasked with performing physicochemical method development and validation as well as compendial method verification to enable rapid progression of various early stage gene therapy candidates into the clinic.

Key responsibilities:

• Establish and oversee a high performing team capable of supporting analytical development activities for gene therapy candidates with an emphasis on physicochemical and compendial methods

• Evaluate and implement new technologies within the Analytical Development department, with a particular emphasis on state-of-the-art separation techniques (HPLC/UPLC and CE), glycan and binding based assays.

• Maintain a cGMP-compliant laboratory environment and ensure departmental SOPs, internal Sanofi standards and applicable regulations are consistently followed

• Write/review method protocols, assay qualification and validation plans/reports and ensure that the documents adhere to GxP requirements and ICH guidelines

• Write/review analytical sections of IND/IMPD filings to enable use of gene therapy candidates in the clinic

• Provide technical oversight and manage workload and staff assignments. Set priorities and objectives for staff to ensure timely completion of deliverables as per the project timelines.

• Develop team members by providing challenging assignments, performance assessments, and coaching.

• Provide guidance and mentorship to help junior staff with their career growth

• Interface with third party contract laboratories as needed to manage project workload

• Ensure compliance to regulatory and corporate safety standards.

• Represent analytical development in setting Sanofi company-wide strategic analytical initiatives, including authoring guidance documents.

Basic Qualifications:

• Ph.D. in Biochemistry, Analytical Chemistry or a related discipline with a minimum of 10 years of relevant industry work experience or a Master's or Bachelor's degree with a minimum of 14 years of relevant industry experience

• Proven expertise/experience in developing and qualifying/validating analytical methods to support product development and regulatory filings, preferably for gene therapy products.

• Sound understanding of regulatory requirements for early stage development of biologics including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents.

• Experience acting as an analytical team leader/representative on CMC teams.

• Excellent communication skills

• Experience managing people in project-based or functional teams

• Strong background in physicochemical methods (e.g. UPLC/HPLC, CE, cIEF including familiarity with equipment from different vendors), excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches

• Proficiency with the use of chromatography data systems such as Chemstation, OpenLab, and/or Empower.

• Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) is required.

Preferred Qualifications:

• Experience with qPCR, ddPCR, ELISA and/or related techniques will be desirable

• General understanding of statistical principles supporting method performance and robustness assessments as well as Design of Experiment approaches used for method development/optimization

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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Keywords: Principia Biopharma Inc., Framingham , Head of Analytical Development, Quality Control, Genomics Medicine & Chemical Manufacturing, Other , Framingham, Massachusetts