Head of Analytical Development, Quality Control, Genomics Medicine & Chemical Manufacturing
Company: Principia Biopharma Inc.
Posted on: June 7, 2021
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.
Establish and oversee a high performing team capable of
supporting analytical development activities for gene therapy
candidates with an emphasis on physicochemical and compendial
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
Interface with third party contract laboratories as needed to
manage project workload
Ensure compliance to regulatory and corporate safety
- Represent analytical development in setting Sanofi company-wide
strategic analytical initiatives, including authoring guidance
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
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
Excellent communication skills
Experience managing people in project-based or functional
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.
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.
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
Keywords: Principia Biopharma Inc., Framingham , Head of Analytical Development, Quality Control, Genomics Medicine & Chemical Manufacturing, Other , Framingham, Massachusetts
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