Quality Control Associate Director Cell Therapy
Company: Sanofi
Location: Framingham
Posted on: May 8, 2022
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Job Description:
Position Overview:This position resides within the Genomic
Medicine Unit (GMU), a part of Sanofi's CMC Development
organization. The GMU Analytical Development/Quality Control
(AD/QC) group has the overall responsibility to establish phase
appropriate control strategies and to develop, qualify, and
validate robust AD/QC methods to support release and
characterization testing of different cellular therapy candidates.
In addition, the group supports cGMP-compliant release and
stability testing of clinical supplies performing both the
product-specific as well as compendia methods.We are looking for a
skilled and highly motivated scientist with broad expertise in
immunology and cell-based assays to join the GMU AD/QC group. This
group will be moving locations from Framingham, MA to Waltham, MA
by June, 2022.Key Responsibilities:Lead multi-functional
development team to establish and evolve current cellular therapy
analytical methods and strategies.Define broad technical objectives
and champions pioneering analytical capabilities to enhance product
function.Troubleshoot existing protocols to increase method
performance, throughput, and ergonomic control, evaluating novel
technology platforms to advance and supersede existing capabilities
and limitations.Lead projects with complex interactions across,
internally and/or externally.Oversee the design, planning, and
execution of complex methods and transversal projects, and performs
deep data dives.Work closely with process and analytical
development teams, as well as manufacturing to identify analytical
deficiencies and propose relevant and meaningful solutions for
enhanced process understanding and control.Support and/or lead
manufacturing investigations and contribute to root cause analysis
and correction action planning.Manage documentation practices of
the group reviewing study plans, reports, and operating procedures,
as well as author and/or contribute to technical reports.Actively
investigate new technologies to complement improved product
characterization and process control.Oversee internal and external
assay transfers consistent with established procedures, and ensure
compliance to procedures.Contribute to routine assay support as
needed, following established procedures and group documentation
practices.Manage individual development plans and mentor staff for
technical understanding and career growth.Basic Qualifications:PhD
in a relevant discipline with a minimum 8 years of relevant
industry experience or Master's or Bachelor's degree in a relevant
discipline with a minimum of 12 years of relevant industry
experience.Experience in developing cellular therapy specific
analytical methods.Experience developing methods with particular
emphasis on immunology, cell-based, and analytical assays for
cellular therapies.Experience developing and implementing novel
methods to improve process and product understanding with proven
troubleshooting skills.Understanding of cellular therapy regulatory
guidance's and ability to translate requirements to develop
clinically relevant process control strategies and product
attribute profiles.Innovative, critical, and creative
thinker.Excellent organizational and communication
skills.Experience with direct reports or managing people in
project-based or functional teams.Preferred
Qualifications:Experience as an analytical development and/or
quality control team leader for a gene or cell therapy
project.Experience in method transfers and gap analysis risk
assessment processes.Experience using QbD principles and tools e.g.
DOE to develop analytical methods.As a healthcare company and a
vaccine manufacturer, Sanofi has an important responsibility to
protect individual and public health. All US based roles require
individuals to be fully vaccinated against COVID-19 as part of your
job responsibilities.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.GD-SALI-SAPDNAt 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.PDN-9486524e-69de-4872-a3b2-dc5f2520cc83
Keywords: Sanofi, Framingham , Quality Control Associate Director Cell Therapy, Executive , Framingham, Massachusetts
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