Novartis Group Companies
QC Microbiology Manager
Novartis Group Companies, Carlsbad, California, United States, 92002
Job Description SummaryLocation: Carlsbad, California (on-site)
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. We are looking for an experienced pharmaceutical industry professional with experience building teams in start-up environments to lead the Microbiology Lab at our new Carlsbad site.
As the QC Microbiology Manager, you will be responsible for release testing, reviewing laboratory data, and leading the QC Micro team.
Job DescriptionKey Responsibilities:Management of Microbiological activities in line with site objectives. Coordination of departmental Operational activities. Track team metrics and ensure KQI/KPI meet requirements.Lead OpEx Projects. Support transfer Projects and validation studies.New equipment commissioning Support (OQ, PQ). Ensure qualification/calibration status of analytical equipment.Investigation of Deviation, OOx, Complaints. Define and implement CAPAs. SOP review and revision.Define improvement areas in process and products.Perform local training and monitor training status for Microbiological QC. Ensure training according to cGxP requirements.Ensure DI and compliance with cGxP and all regulatory requirements. Collaboration in GxP internal audits and ensure fulfillment of internal/external audit and inspection plans.Management of documentation and Methods according to cGxP.Ensure compliance of products and other materials with specifications and with corporate, health authorities, and E5 requirements.Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.Essential Requirements:BS in Microbiology or relevant scientific field5 years of experience in a GMP quality control microbiology environment involved with environmental monitoring of clean rooms, isolator sterility testing, gram staining, bioburden, endotoxins, etc.2 years of experience in a people management role.Desirable Requirements:Advanced degreeSalary RangeThe pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 per year; however, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities.Benefits and rewards:
Read our handbook to learn about all the ways we'll help you thrive personally and professionally:
Thrive Together (novartis.com).Commitment to Diversity and Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.#LI-OnsiteEEO Statement:The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.Accessibility and reasonable accommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to
tas.nacomms@novartis.com
or call +1 (877)395-2339 and let us know the nature of your request and your contact information.
#J-18808-Ljbffr
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. We are looking for an experienced pharmaceutical industry professional with experience building teams in start-up environments to lead the Microbiology Lab at our new Carlsbad site.
As the QC Microbiology Manager, you will be responsible for release testing, reviewing laboratory data, and leading the QC Micro team.
Job DescriptionKey Responsibilities:Management of Microbiological activities in line with site objectives. Coordination of departmental Operational activities. Track team metrics and ensure KQI/KPI meet requirements.Lead OpEx Projects. Support transfer Projects and validation studies.New equipment commissioning Support (OQ, PQ). Ensure qualification/calibration status of analytical equipment.Investigation of Deviation, OOx, Complaints. Define and implement CAPAs. SOP review and revision.Define improvement areas in process and products.Perform local training and monitor training status for Microbiological QC. Ensure training according to cGxP requirements.Ensure DI and compliance with cGxP and all regulatory requirements. Collaboration in GxP internal audits and ensure fulfillment of internal/external audit and inspection plans.Management of documentation and Methods according to cGxP.Ensure compliance of products and other materials with specifications and with corporate, health authorities, and E5 requirements.Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.Essential Requirements:BS in Microbiology or relevant scientific field5 years of experience in a GMP quality control microbiology environment involved with environmental monitoring of clean rooms, isolator sterility testing, gram staining, bioburden, endotoxins, etc.2 years of experience in a people management role.Desirable Requirements:Advanced degreeSalary RangeThe pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 per year; however, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities.Benefits and rewards:
Read our handbook to learn about all the ways we'll help you thrive personally and professionally:
Thrive Together (novartis.com).Commitment to Diversity and Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.#LI-OnsiteEEO Statement:The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.Accessibility and reasonable accommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to
tas.nacomms@novartis.com
or call +1 (877)395-2339 and let us know the nature of your request and your contact information.
#J-18808-Ljbffr