Senior Research Associate

Job Overview

We are seeking a highly motivated and talented Senior Research Associate (SRA) to join our Formulation and Process Development (FPD) group.  FPD is part of the global Biologics Drug Product Development & Manufacturing group, a critical R&D function enabling the manufacturing of stable and deliverable dosage forms along the complete development timeline from molecule selection to commercial tech transfer. The selected candidate will be responsible primarily for formulation and process development for protein and monoclonal antibody therapeutics for liquid and lyophilized dosages. Key expectations and training will include solid understanding in protein structure, chemistry, and characterizations. You will be part of a team with global responsibility for formulation and process development for Protein therapeutics and Gene Therapy. The candidate will have the opportunity to work on different facets of drug product formulation and process development for different modalities such as monoclonal antibodies (mAb), multi-specific antibodies, therapeutic enzymes, fusion proteins, viral capsids (recombinant AAV and Lentiviral vectors), Lipid Nanoparticles and Cell Therapies

Key Responsibilities

• Execution of formulation, process development and stability studies for both liquid and lyophilized products.

• Work with internal and external partners to efficiently and comprehensively address formulation, stability and compatibility aspects using established assays, across a variety of technological platforms and disciplines.

• Planning, prioritization and initiation of concurrent experimental procedures for multiple programs to ensure their timely completion is essential.

• Provide technical mentorship to other team members.

• Take ownership of assigned studies to ensure timely completion.

• Maintain a strong work ethic and good documentation practices including electronic laboratory notebook maintenance and writing of technical reports and SOPs.

• Analyze, compile and present results to internal and cross functional teams comprised of members from multiple groups and stakeholders

• Support technology transfer activities to clinical and commercials manufacturing sites.

Basic Qualifications

• Master's degree in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Biological Engineering, or a Bachelor's degree with a minimum of 2 years of relevant industry experience.

• Strong work ethic, be team- and project-focused and motivated to produce high quality data on an aggressive timeline. 

• Ability to multi-task, learn new skills, possess flexibility and adaptability is needed for this fast-paced team environment.

• A good understanding of protein structure, chemistry, and degradation mechanisms

Preferred Qualifications

• Hands-on experience with common analytic technologies, such as SEC, SDS-PAGE, DLS, DSC, IEF/cIEF, spectroscopy and calorimetry

• Experienced in formulation optimization, stability study, product process development and control for each unit operation, including mixing, filtration, and fill finish, and technology transfer.

• Previous experience biopharmaceutics manufacturing, lyophilization and process simulation is preferred. Working knowledge in overall biopharmaceutical development process for injectable drug products of biologic drug candidates.

• Basic understanding of statistical data analysis, and good written and verbal communication skills in data presentation and authoring study reports and regulatory filing documents. 

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. 

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.

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.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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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.