Global Microbiology Principal Scientist

TITLE:

Global Microbiology Principal Scientist

Title: Global Microbiology Principal Scientist

Reports To: Head, Site Quality

Location: Raleigh, NC

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category.

MINIMUM QUALIFICATIONS:

License/Certifications: N/A

Travel: Approximately 10% travel.

Minimum: Bachelor’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline. Advanced degree in Microbiology preferred. Ten + years of experience in microbiology within a pharmaceutical or biotechnology industry, with a focus on sterile fill-finish operations.  Advanced understanding of microbiology principles as they apply to sterile pharmaceutical manufacturing, especially in aseptic environments. Extensive knowledge and practical experience with contamination control, environmental monitoring, and microbiological testing.  Experience working with and collaborating with the functions involved in the manufacture of parenteral drug products (e.g. operations, technical services, quality control/assurance).  Proven track record working with regulatory agencies such as the FDA, EMA, HPRA, HC and other global health authorities, and familiarity with cGMP regulations.  Demonstrated expertise in aseptic manufacturing processes, risk assessments, and quality management systems. Prior experience in leading Microbiology programs for aseptic pharmaceutical manufacturing facilities, a must.

Technical Skills:  

Proficiency in microbiological testing methods, sterility assurance, and contamination control strategies.  Experience with advanced technologies such as rapid microbiological methods (RMM) and cleanroom microbiology. Strong analytical and problem-solving skills, with the ability to interpret microbiological data and trends to drive improvements. Ability to provide training on complex scientific concepts to a broad audience.  Familiarity with global regulatory requirements, quality standards, and best practices in aseptic processing across various regions. Ability to gown into cleanroom attire, as required to perform job responsibilities. Ability to wear PPE and other safety related equipment.

Leadership Skills:

Strong leadership abilities, with experience leading microbiology teams and mentoring junior scientists. Strong self-management, decision-making, and organizational skills.  Ability to work cross-functionally with production, quality, regulatory, and R&D teams to ensure alignment on microbiological standards.  Excellent communication skills, capable of presenting complex microbiological information to technical and non-technical stakeholders.

Certifications (Preferred):  

Certification in aseptic processing, sterility assurance, quality systems, or related microbiological disciplines.  Professional memberships in microbiology or pharmaceutical organizations (e.g., PDA, ISPE, ASTM).

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

• Embrace Indivior core culture principles.
• Embrace the dynamics of team support, team collaboration and team success. 
• Celebrate the core wins of the organization and empower others to sustain a quality mindset. 
• Always have patient safety at the forefront in the efforts to provide safe and effective products to enhance and improve lives. 
• Celebrate and embrace diversity, equity and inclusion. 

BENEFITS:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the import