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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
  • Laboratory management and/or operations experience preferred
  • 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

If you are interested in pursuing this opportunity, please respond back and include the following:
 
  • MS WORD Resume
  • required compensation.
  • Contact information.
  • Availability
 
Upon receipt, one of our managers will contact you to discuss the position in full detail.

Jason Denmark
Recruiting Manager

INTERMEDIA GROUP, INC.
EMAIL: jdenmark@intermediagroup.com
LINKEDIN: https://www.linkedin.com/in/jasondenmark/

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