GCI Bacteriology Team Lead - VaccineJob ID: 3312463Location: Swiftwater, Pennsylvania, United StatesEmployment Type: Full-timeRelocation Assistance Available: Possible for ideal candidateScheduled work from home dayson-site 3 days per week, days from home cannot be BOTH Monday and Friday

About the Role

Our Award-Winning Client, a nationally recognized leader in pharmaceutical and biotech advancements, is seeking a GCI Bacteriology Team Lead - Vaccine to oversee the development, qualification, and execution of bacteriological assays supporting vaccine clinical endpoints from early-stage research through advanced clinical phases. This role will drive the evolution of immunological methodologies in bacteriology while ensuring compliance with regulatory standards. Based in Swiftwater, PA, this position operates on a hybrid schedule, requiring three on-site days per week.

Key Responsibilities

• Lead and mentor a team of scientists with varying expertise levels, including Bachelor’s, Master’s, and Ph.D. professionals, to develop and optimize bacteriological assays.
• Spearhead innovations in immunological testing, ensuring high-quality assay execution in compliance with GCLP regulations.
• Engage in cross-functional collaboration with global teams, immunology specialists, and regulatory bodies to enhance methodologies and advance vaccine development.
• Act as a key representative in technical discussions, regulatory meetings, and scientific conferences, ensuring the latest advancements are incorporated into research strategies.
• Oversee laboratory operations, ensuring proper resource allocation, equipment maintenance, and reagent quality control.
• Contribute to high-impact scientific publications and presentations related to vaccine research, assay development, and immunogenicity.
• Maintain and optimize laboratory information management systems (LIMS), ensuring streamlined data tracking and compliance.
• Foster a culture of continuous learning, professional development, and scientific excellence within the team.

Required Qualifications & Expertise

• Educational Background:
  • BS in Life Sciences with 15+ years of relevant experience, OR
  • MS in Immunology, Microbiology, Virology, or Biochemistry with 12+ years of relevant experience, OR
  • Ph.D. in a related field with 8+ years of relevant experience.
• Technical Expertise:
  • In-depth knowledge of serum bactericidal assays (SBA) utilizing both Human Complement (HC) and Baby Rabbit Complement (BR).
  • Experience leading and managing teams of 10+ scientists in a regulated laboratory setting.
  • Strong familiarity with bioanalytical method development for vaccine research.
  • Expertise in LIMS systems, reagent characterization, laboratory equipment management, and laboratory operational procedures.
  • Proven ability to develop, optimize, and implement immunogenicity assays and other advanced bioanalytical techniques.
  • Deep understanding of GXP practices, clinical sample databases, and regulatory compliance.
  • Experience in both early-phase product development and clinical-stage testing.
  • Knowledge of laboratory management principles, including budget oversight and project coordination.
  • Strong communication skills with a proven ability to engage in cross-functional and cross-cultural collaboration.

Why Join Our Award-Winning Client?

• Work with a globally recognized industry leader in vaccine innovation.
• Be part of a high-impact scientific team contributing to groundbreaking vaccine research.
• Access a comprehensive benefits package, including high-quality healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.
• Seize opportunities for professional development, including leadership training, internal mobility, and career advancement.
• Enjoy a collaborative work environment that values scientific excellence, innovation, and employee growth.

Candidate Details

• Seniority Level: Director
• Management Experience Required: Yes
• Willingness to Travel: Occasionally
• Laboratory Management and Operations Experience Preferred
• Experience in Functional Bioanalytical and LBA Instrumentation & Techniques
• Familiarity with Clinical or Sample Databases and Inventory Management
• Proven Track Record of Leadership, Scientific Innovation, and Regulatory Compliance

Job ID: 3312463

Bold Note: Resumes will be maintained in strict confidentiality until such time as we engage in a detailed discussion regarding a specific opportunity, and both parties mutually agree to proceed. We consistently receive new opportunities every day. Should your professional background closely align with the specific requirements of our client, we will promptly reach out to you to initiate further exploration of potential opportunities.