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We seek an energetic and highly motivated Associate Director to join the newly formed Bioassay and Molecular Analytical Development (BAM) team within the Genomic Medicine Unit (GMU) and Bioanalytics (BioA) groups in Waltham, MA.

The successful candidate will lead the design and implementation of cellular, ligand-based and molecular assays to support gene therapy programs in all phases of clinical development. The associate director will manage a team of scientists and associates who develop, qualify and implement analytical methods for drug product release and characterization within a GMP environment. The incumbent will also be responsible for writing patent applications and/or external publications promoting internal innovation and technology advancements.

KEY RESPONSIBILITIES

• Lead a group of scientists and associates responsible for bioassay (potency) and molecular method development and phase appropriate qualification for a portfolio of gene therapy programs.

• Evaluate and implement new technologies within the BAM group with a particular emphasis on cell-based assays and ELISA methods.

• Collaborate across the larger Bioanalytics group involving the cell line engineering and automation teams to develop state of the art, phase appropriate bioassays for gene therapy products covering a range of modalities.

• Maintain a cGMP-compliant laboratory environment and ensure departmental SOPs, internal Sanofi standards and applicable regulations are consistently followed

• Write/review method protocols, assay qualification and validation plans/reports ensuring that the documents adhere to GxP requirements and ICH guidelines

• Write/review analytical sections of IND/IMPD filings to enable use of gene therapy candidates in the clinic

• Provide technical oversight and manage workload and staff assignments. Set priorities and objectives for staff to ensure timely completion of deliverables as per project timelines.

• Develop team members by providing challenging assignments, performance assessments and coaching. Provide guidance and mentorship to help junior staff with career growth

• Interface with third party contract laboratories as needed to manage project workload

• Ensure compliance with regulatory and corporate safety standards.

• Participate in CMC teams as an Analytical Team Lead responsible for defining the analytical testing plan including the definition of drug product CQAs and development of appropriate analytical assays to measure these attributes in gene therapy programs

• Represent GMU Bioanalytics in setting Sanofi company-wide strategic analytical initiatives, including authoring guidance documents.

BASIC QUALIFICATIONS

• PhD in a life sciences discipline with a minimum of 8 years of relevant industry experience, or a Master’s or Bachelor’s degree with a minimum of 12 years of relevant industry experience.

• Proven expertise/experience in developing and qualifying/validating analytical methods to support product development and regulatory filings, preferably for gene and/or cell therapy products.

• Strong background in cell and molecular based methods (e.g. bioassay, ligand binding, flow cell cytometry and molecular assays), demonstrated experience in developing approaches for potency analysis for parallelism in compliance with regulatory guidance. Excellent method troubleshooting skills.

• Sound understanding of regulatory requirements for early-stage development of gene and/or cell therapy including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents

• Excellent communication skills

• Minimum 5+ years of experience managing people in project-based or functional teams

PREFERRED QUALIFICATIONS

• Experience working in a matrixed environment

• Experience in a GMP environment that translates into the ability to adhere to all appropriate GMP standards and processes such as invalid result investigations, deviations, and CAPAs will be considered an advantage.

• General understanding of statistical principles supporting method performance and robustness assessments as well as Design of Experiment approaches used for method development/optimization

• Track record in writing patents and external publications

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.