Sanofi Group Scientist Bioanalytical- Framingham/MA in Framingham, Massachusetts
We are seeking a Scientist to join the Bioanalysis group within Biomarkers & Clinical Bioanalysis (BCB), a global department within the Translational Medicine and Early Development unit of Sanofi. The individual in this position should have hands-on experience in the development, validation and implementation of biological assays for the analysis of biomarkers, pharmacokinetics and immunogenicity. This position will work in a team setting to develop complex assays, implement testing strategies, execute projects to meet controlled timelines, and prepare reports suitable for regulatory submission to support clinical development.
What makes this position unique?
Biomarkers and Clinical Bioanalysis is a global group that plays a critical role in the development of new drugs, contributing bioanalytical strategy and support from nonclinical development to clinical proof of concept. The growing need for translational studies makes BCB highly visible and members are key contributors to program teams. The individual in this position will have the opportunity to support multiple projects and to collaborate transversally with colleagues across the globe, each contributing expertise in a complimentary aspect of drug discovery and development.
Benefits of working in this role
The individual in this position will have the opportunity to contribute to the development of novel biotherapeutics including enzyme replacements, nanobodies, multi-specific antibodies and gene therapies to treat a variety of disease indications.
The BCB department provides a fast-paced, dynamic and collaborative environment where management, scientists and research associates work as a team to develop complex and cutting edge biological assays.
Position supports career growth within the scientific track as well as development in project and people management.
- The position will be located in Framingham, MA (Boston area) but candidates must be willing to relocate to Cambridge, MA.
Independently develop, validate, and implement complex bioanalytical assays to support PK, immunogenicity, and biomarker testing in nonclinical and clinical studies
Serve as the bio-analytical lead for assigned projects and Principal Investigator for regulated studies; provide scientific oversight and data interpretation and ensure data meets compliance requirements according to internal best practices and regulatory guidances
Author standard operating procedures, study plans and reports, and abstracts; present scientific data to fellow colleagues
Take a leadership role in ensuring regulatory and safety compliance in the laboratory; promote operational excellence by leading process improvement efforts
Manage multiple project commitments under the confines of challenging time lines
Work with global teams to develop and operationalize testing strategies to support new and ongoing clinical programs; work with outsourcing operational group and CROs to transfer and manage external testing efforts
Requirements & Qualifications
Ph.D. degree in the field of immunology, biochemistry, biology, or other life-science field with 0-2 years of post-graduate experience, or Master’s degree in a similar field with 3-5 years of experience, or Bachelor’s degree with 8+ years of experience; industry experience preferred
A diverse skill-set in bioanalytical assay techniques such as ligand binding (ELISA, MSD, etc.), and multiplexed biomarker analysis, and enzyme activity assays
Outstanding written and oral communication skills along with the ability to work collaboratively in a team setting
Demonstrated knowledge and skills in solving scientific problems, ability to troubleshoot
Experience directing the work of junior staff members in assay development efforts
Familiar with industry’s best practices in bioanalytical assay development and regulatory expectations (FDA and EMA) for validation of PK, immunogenicity and biomarker assays
Familiarity with common molecular biology techniques (i.e. PCR, DNA/RNA isolation, etc) and preparation and sequencing of RNA-seq libraries with various Illumina sequencing platforms (i.e. NextSeq, miSEQ, etc.) is desirable
Experience working in a regulated environment (GLP, GCLP) in support of nonclinical and clinical development projects
Familiar with instrument application software and basic statistical software such as EXCEL, SoftMax Pro, JMP, GraphPad Prism, etc.
Experience working with a laboratory information system, such as Watson LIMS, to manage sample tracking and data analysis
Terms of employment
People management responsibilities – No direct management responsibilities however candidate will be expected to train and mentor junior staff.
Travel requirements – Minimal
Start date – As soon as possible
Working hours – Business hours
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.