Indivior PLC
Global Microbiology Principal Scientist
Indivior PLC, Raleigh, North Carolina, United States, 27601
Global Microbiology Principal ScientistLocation:
Raleigh, NC
Time Type:
Full time
Posted On:
Posted 13 Days Ago
Job Requisition ID:
R2518
Indivior is a global specialty pharmaceutical company dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients worldwide will have access to evidence-based treatment for substance use disorders (SUD) and serious mental illnesses.
MINIMUM QUALIFICATIONS:
Bachelor’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline. Advanced degree in Microbiology preferred.
Ten + years of experience in microbiology within a pharmaceutical or biotechnology industry, focusing 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 collaborating with functions involved in the manufacture of parenteral drug products.
Proven track record with regulatory agencies such as the FDA, EMA, HPRA, HC, and familiarity with cGMP regulations.
Demonstrated expertise in aseptic manufacturing processes, risk assessments, and quality management systems.
Prior experience leading Microbiology programs for aseptic pharmaceutical manufacturing facilities.
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.
Ability to provide training on complex scientific concepts.
Familiarity with global regulatory requirements and quality standards.
Ability to gown into cleanroom attire and wear PPE as required.
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.
Excellent communication skills for presenting complex microbiological information.
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:
Embrace Indivior core culture principles.
Celebrate the core wins of the organization and empower others to sustain a quality mindset.
Always have patient safety at the forefront.
Celebrate and embrace diversity, equity, and inclusion.
BENEFITS:
3 weeks’ vacation plus floating holidays and sick leave.
401(k) and Profit Sharing Plan with company match.
U.S. Employee Stock Purchase Plan with a 15% discount.
Comprehensive Medical, Dental, Vision, Life, and Disability coverage.
Health, Dependent Care, and Limited Purpose Flex Spending and HSA options.
Adoption assistance and tuition reimbursement.
Concierge/personal assistance services.
Voluntary benefits including Legal, Pet Insurance, and Critical Illness coverage.
Gym, fitness facility, and cell phone discounts.
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
COMPLIANCE OBLIGATIONS:
Always act with honesty and integrity.
Know what policies apply to your role and adhere to them.
Speak Up: If you see something, say something.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY: EOE/Minorities/Females/Vet/Disabled
About UsPassion. Innovation. Achievement.
All are key aspects of a career with Indivior. We are a worldwide family united under one common purpose – the patient.
We look forward to hearing from you.
#J-18808-Ljbffr
Raleigh, NC
Time Type:
Full time
Posted On:
Posted 13 Days Ago
Job Requisition ID:
R2518
Indivior is a global specialty pharmaceutical company dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients worldwide will have access to evidence-based treatment for substance use disorders (SUD) and serious mental illnesses.
MINIMUM QUALIFICATIONS:
Bachelor’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline. Advanced degree in Microbiology preferred.
Ten + years of experience in microbiology within a pharmaceutical or biotechnology industry, focusing 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 collaborating with functions involved in the manufacture of parenteral drug products.
Proven track record with regulatory agencies such as the FDA, EMA, HPRA, HC, and familiarity with cGMP regulations.
Demonstrated expertise in aseptic manufacturing processes, risk assessments, and quality management systems.
Prior experience leading Microbiology programs for aseptic pharmaceutical manufacturing facilities.
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.
Ability to provide training on complex scientific concepts.
Familiarity with global regulatory requirements and quality standards.
Ability to gown into cleanroom attire and wear PPE as required.
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.
Excellent communication skills for presenting complex microbiological information.
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:
Embrace Indivior core culture principles.
Celebrate the core wins of the organization and empower others to sustain a quality mindset.
Always have patient safety at the forefront.
Celebrate and embrace diversity, equity, and inclusion.
BENEFITS:
3 weeks’ vacation plus floating holidays and sick leave.
401(k) and Profit Sharing Plan with company match.
U.S. Employee Stock Purchase Plan with a 15% discount.
Comprehensive Medical, Dental, Vision, Life, and Disability coverage.
Health, Dependent Care, and Limited Purpose Flex Spending and HSA options.
Adoption assistance and tuition reimbursement.
Concierge/personal assistance services.
Voluntary benefits including Legal, Pet Insurance, and Critical Illness coverage.
Gym, fitness facility, and cell phone discounts.
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
COMPLIANCE OBLIGATIONS:
Always act with honesty and integrity.
Know what policies apply to your role and adhere to them.
Speak Up: If you see something, say something.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY: EOE/Minorities/Females/Vet/Disabled
About UsPassion. Innovation. Achievement.
All are key aspects of a career with Indivior. We are a worldwide family united under one common purpose – the patient.
We look forward to hearing from you.
#J-18808-Ljbffr