Sanofi Group Bioprocess Analytical Scientist in Waltham, Massachusetts
The Genomic Medicine Unit (GMU) operates with the mission to develop robust, scalable, cost effective, and innovative cell and viral vector manufacturing processes and platforms. The BioProcess Analytics group is responsible for developing and executing analytical methods to support our process development and manufacturing operation teams for current and future gene therapy manufacturing platforms. The BioProcess Analytics group located in Waltham, MA, is seeking an experienced analytical scientist to join our team of talented individuals. The successful candidate must have hands on experience in developing analytical methods with proven capabilities to independently manage projects. Scientific knowledge in cell and gene therapy analytics, is preferred. The candidate must be highly motivated, independent, collaborative, and able to communicate effectively with a cross-functional team.
Support team in developing broad analytical strategies to advance product and process understanding.
Network across the bioanalytical unit to align on development objectives to ensure continuity and calibration of analytical technology platforms.
Design (DOE), plan, and execute method development experiments and perform deep data dives.
Troubleshoot existing protocols to increase method performance, throughput and ergonomic control.
Evaluate new technologies to complement and enhance current analytical capabilities, with a focus on automation and high throughput needs.
Support process development and manufacturing teams in establishing analytical support needs for study plans, process monitoring, control and investigations.
Work closely with process development and manufacturing to identify analytical deficiencies and propose relevant and meaningful solutions for enhanced process understanding and control.
Lead internal and external assay transfers consistent with established procedures.
Contribute to routine assay support as needed, following established procedures and group documentation practices.
Write protocols and operating procedures, author and/or contribute to technical reports.
Perform method specific safety risk assessments and write Job Safety Assessment to establish suitable HSE controls.
Represent group at inter-departmental meetings, work streams and conferences.
Manage personal individual development plans.
PhD in biological sciences or Masters degree with a minimum of 4 years of relevant industry experience or a Bachelors degree with a minimum of 6 years of relevant industry experience.
Relevant demonstrated experience in developing analytical methods supporting process understanding and product characterization.
Innovative, critical and creative thinker.
Excellent organizational and communication skills.
Able to work independently and function within a collaborative/team-oriented environment.
Experience in method transfers and gap analysis risk assessment processes.
Experience using QbD principles and tools e.g. DOE to develop analytical methods.
Experience with automated analytical technology platforms for high throughput testing.
Experience with gene therapy regulatory guidance’s, specific to cell and gene therapy products.
Experience with cGMPs and analytical quality requirements for method qualification/validation.
Experience in developing and implementing novel methods to improve process and product understanding.
Special Working Conditions:
- Required to work in a Biosafety Level 2 environment, that may include large scale operations support (LS-BL2).
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 all.