Senior Scientist Bioassay Development and Quality Control

Sanofi; Waltham, Northern (MA, KY); Hybrid; USD 101,000 - 145,000; Full time

Benefits offered by this job

14 weeks parental leave

Health insurance

Competitive compensation

Job summary

Sanofi in Waltham, MA is seeking a Senior Scientist to advance potency method development and QC testing for gene therapy products in a fast-paced GMP environment. You will perform hands-on bioassay development, qualification, validation and CRO transfer, writing SOPs and reports, and presenting results to the team.

The ideal candidate has a PhD in Biological Sciences (MS considered), 4+ years in industry with GMP experience, and strong knowledge of potency assays, flow cytometry, and analytical

Qualifications

• PhD in Biological Sciences or related field required; MS considered.
• 4+ years of GMP experience in a related role.
• Experience with gene therapy potency assays and analytical method transfer.

Responsibilities

• Early-stage GMP release testing and maintaining GMP-compliant environment.
• Serve as SME for biological potency assays for viral and non-viral products.
• Development, qualification, validation and transfer of analytical methods.

Skills

Bioassay development

GMP

QC testing

Flow cytometry

DOE

Data analysis

Regulatory guidance knowledge

Education

PhD in Biological Sciences

MS considered

Tools

BioVia

Job description

**Job Title:** Senior Scientist Bioassay Development and Quality Control* Location: Waltham, MA**About the Job:**Opportunity to join a fast-paced Gene Therapy bioanalytical team focusing on potency method development, qualification, QC testing and CRO transfer in a compliant GMP environment. This position will improve analytical capacity for the potency team, allowing more programs to progress efficiently through early phase development. The successful candidate will be responsible for method development for multiple viral and non-viral gene therapies through hands-on work including method development and optimization, SOP and report writing and providing group presentations. This is a great opportunity for an energetic and dedicated team player willing to do what it takes to support our goal of releasing critical medicines to patients.Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.**About Sanofi:**We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.**Main Responsibilities:*** Responsible for early-stage GMP release testing and maintaining a GMP compliant environment.* Serve as a subject matter expert (SME) for biological potency assays for viral and non-viral products, define the best scientific approaches and analysis methods for quantitative bioassays* Development, qualification and validation and transfer of analytical methods* Master Sanofi quality systems providing expertise and coaching to team members* Perform analytical support testing, ensuring timely completion and delivery of analytical results with appropriate documentation to support product development during clinical phases* Participate in analytical leadership teams for viral and non-viral programs* Take an active role in Lab maintenance, organization, GMP and safety compliance* Ensure compliant use of electronic notebooks* Work in a matrixed environment and interact productively with associates, scientists and management at various levels, both locally and internationally**About You:**Education:* PhD in Biological Sciences or related fields, Master's Degree (MS) will be considered.* 2+ years of experience in a GMP environment *(required)** 4+ years of relevant industry experience, including gene therapy *(preferred)*Experience & Technical Skills:* Bioassay development experience* Experience in performing QC release and stability assays* Aptitude to manage multiple types of quality events including deviations, change controls, lab investigationsPreferred Qualifications:* Experience with flow cytometry, FRET-assays, effector function assays, reporter cell lines, PCR analysis and/or ELISA endpoints, DOE approaches where appropriate* Experience automating cell-based assays* Comprehensive knowledge of gene therapy analytics including potency and impurity paradigms, knowledge of gene therapy regulatory guidance* Experience performing analytical support for structure/function and in-process studies* Knowledge of various approaches to data analysis, strong understanding of relative potency assay analysis including software and regulatory expectations* Experience in technology transfer to other sites* Experience with BioVia products**Why choose us?*** Bring the miracles of science to life alongside a supportive, future-focused team.* Discover endless opportunities through working with a talented and dedicated team in an integrated environment. Grow your talent and drive your career in gene therapy.* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.* Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.* Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.* Help improve the lives of millions of people globally by making drug development quicker and more effective.Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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-SA#LI-SA#LI-Onsite#vhd# Pursue *progress*, discover *extraordinary*Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here*US and Puerto Rico Residents Only*Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.*North America Applicants Only*The salary range for this position is:$100.500,00 - $145.166,66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.