HYBRID - GCI Bacteriology Team Lead - Vaccine - Swiftwater, PA - Relocation Available - to $200,000
Swiftwater, PA · $147,000 to $200,000
OPEN JOB: GCI Bacteriology Team Lead - Vaccine LOCATION: Swiftwater, Pennsylvania ***HYBRID: on-site 3 days per week, days from home cannot be BOTH Monday and Friday ***Relocation Assistance Available SALARY: $147,000 to $200,000 SENIORITY LEVEL - Director INDUSTRY: Pharmaceutical / Biotech JOB CATEGORY: Research & Development
About the job
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.
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.
REQUIREMENTS:
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