GCI Bacteriology Team Lead

Title: GCI Bacteriology Team Lead - Vaccine
Location: Swiftwater, PA
Job Type: FTE/Permanent

Job Description:
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 regulated environment. The candidate will work closely with global project teams and immunology leads to drive continuous improvement in techniques and technologies for Client vaccine assessments. This position reports to the Head of Global Clinical Immunology.

Main Responsibilities:
Primary Responsibilities

• Lead a large team of Bachelors, Masters, and Ph.D. scientists to develop, validate, and execute Client immunological methodologies in bacteriology for vaccine clinical endpoints.
• Optimize existing methodologies in bacteriology, delivering high-quality results in a regulated environment.
• Collaborate closely with global project teams and immunology team leads.
• Drive continuous improvement and advancement of techniques and technologies for Client vaccine candidates.
• 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 department heads and scientists to ensure end-to-end communication is maintained.
• Serve as function representative and SME at key strategic internal/external meetings, conferences, and key meetings with CROs and regulatory authorities.
• Act transversally with global transversal operations, clinical development, and global regulatory affairs to build and optimize Client bioanalytical methods for fast-moving projects to maximize scientific quality and timeliness while 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:
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 organizational 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 of 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 stages.
• 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.