Biosample Manager

The Sample Manager is an expert in biological sample handling, ensuring the procedures for collection, storage and shipment of specimens are followed for measurements of clinical samples of R&D Translational Medicine and Early Development. The Sample Manager is responsible for study set-up in the analytical LIMS software for clinical trials and non-clinical studies based on defined standards in adherence with study timelines. She / He is expert working in a regulated environment.

The Sample Manager is a key partner for the clinical operations teams, bioanalytical and pharmacokinetics experts, and outsourcing departments. He/she manages the studies in the analytical software in compliance with the standards to support flawless conduct of clinical trials. In addition, he/she is an expert in management of clinical samples including, but not limited to, pharmacokinetic (PK), anti-drug antibodies (ADA), anti-drug conjugates (ADC) and biomarkers (BM)

Key Requirements:

• Expertise in Laboratory Information Management Systems (e.g. Watson LIMS) for set up of study design, sample handling, tracking, and sample storage

• Basic knowledge of clinical development and its processes

• Experience for sample reconciliation to investigate and resolve samples discrepancies between the bioanalytical lab/LIMS and the clinical database

• Basic knowledge of bioanalytical methods

• Basic understanding of biomarkers

• Deep knowledge of oncology and/or rare disease clinical trials

• Creating relevant documents e.g. sample management plan for studies and process maps

• Develops template documents to be used for tracking clinical samples in clinical trials, creates trial-specific templates and ensures their timely completion and follow-up

• Reviews the sample-related text in study documents and ensures consistency across studies, as appropriate

• For the samples which assigned for future research: work together with the study team to identify the most appropriate and cost-effective biobank storage strategy

• Ability to handle multiple tasks and prioritize effectively, detail oriented and highly accurate

• Experience working in a regulated environment and ability to apply the quality requirements defined in GLP, GCLP internal procedures. according to GLP/GCLP/ standards.

• Anticipates complex problems and proactively works to minimize their impact

•  Good communication skills, interfacing with cooperating departments in development and with external partners (Central Laboratories or third-party Laboratories

• Team player keen on receiving and sharing knowledge/expertise in global teams

• Demonstrates high motivation for the job

• Self-motivated and interested working in a complex environment

• Proficient English written and verbally

• Proficient knowledge in Excel

Qualifications:

• Bachelor degree, preferably in a life science or -related area (e.g. bioanalytical / computer sciences or similar technical field) or equivalent experience (at least 3 years) in bioanalytical areas

Skills, Expertise and Contribution:

• Team Player, able to work in a cross-functional global environment

• Project Management and organizational skills

• Comprehensive knowledge of ICH-GCP

• Good communication skills

• Being accountable: exercising judgement / understanding impact of decisions

• Able to manage multiple and varied tasks and prioritize workload with attention to detail

• Computer Knowledge

Note: Framingham site is moving to Cambridge Crossing in the end of 2022

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health.  This position will 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.

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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.