The Head of the Bacteriology platform directs several laboratories responsible for the development, qualification, validation, and execution of bacteriological assays required to support vaccine clinical endpoints from Phase I to Phase IV. The role involves strategizing new immunological methodologies in bacteriology, optimizing existing assays and delivering high quality results in a GCLP regulated environment. The candidate will work closely with global project teams and immunology leads to drive continuous improvement in techniques and technologies for novel vaccine assessments. This position reports to the Head of Global Clinical Immunology and is based in Swiftwater, PA.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities
Primary responsibilities
Lead a large team of Bachelors, Masters, and Ph.D. scientists to develop, validate, and execute novel immunological methodologies in bacteriology for vaccine clinical endpoints.
Optimize existing methodologies in bacteriology, delivering high-quality results in a GCLP-regulated environment.
Collaborate closely with global project teams and immunology team leads.
Drive continuous improvement and advancement of techniques and technologies for novel vaccine candidates at Sanofi Vaccines R&D.
Represent the team on project, process, and investigation teams, ensuring appropriate planning, organization, and resource allocation.
Management of Key Interfaces:
Interact and liaise within the other platform leads and GI department heads and scientists to ensure end-to-end GI communication is maintained.
Serve as function representative and SME at key strategic internal/external meetings, conferences/congresses, and key meetings with CROs and with regulatory authorities.
Act transversally (including with global transversal operations, clinical development, global regulatory affairs) to build and optimize novel bioanalytical methods for fast-moving projects to maximize scientific quality and timeliness whilst operating within budget targets.
Act as a contributing author to high-quality publications describing assay development and/or the immunogenicity and efficacy of candidate and approved drugs in technical, medical, or scientific journals.
About You
Requirements
Essential Attributes
Expertise in serum bactericidal assays (SBA's) using both Human Complement (HC) and Baby Rabbit Complement (BR) is essential.
Experience managing teams of 10+ individuals.
Experience with quality systems and processes in a regulated environment
Expertise with LIMS systems, reagent characterization and qualification, laboratory equipment and supplies
Ability to interact effectively with people from diverse cultural backgrounds and skill sets to achieve scientific and operational excellence.
Strong commitment to scientific excellence and innovation.
Excellent interpersonal skills to ensure target completion and foster workplace respect.
Leadership that promotes cross-group collaboration to achieve Sanofi R&D goals, and developing leadership skills in direct reports
Record of innovation as evidenced by a strong publication record, inventorship on patents/filings and presentations at major conferences
Proven experience in management of personnel, budget, and projects.
Education and Background
BS degree in life sciences with 15+ years of relevant experience, MS or Ph.D. in immunology, microbiology, virology or biochemistry (MS requires 12 + years, Ph.D 8+ years of relevant experience)
5+ years experience working in a regulated laboratory as a research scientist or laboratory manager preferably in pharma R&D
Experience in the development of new bioanalytical characterization methods for vaccines.
Familiar with a broad range of functional bioanalytical and LBA instrumentation and techniques.
Strong familiarity with immunogenicity assays.
Understanding of GXP practices and procedures required
Work experience both in early phase product development and clinical stage
Familiarity with clinical or sample databases and inventory management required
Proven leadership and managerial experience in multi-functional and matrixed teams
Familiarity with laboratory testing regulations
Proven leadership, verbal and written communication, organizational and team management skills
Proven ability to develop and implement new procedures/processes
Why Choose Us
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
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.
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.
