372443BR
5月 08, 2023
USA
About the Role
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
The Supervisor, Quality Control Microbiology, works with the Quality Control team in supporting our efforts of RLT therapy. This role is responsible for the day-to-day oversight of the QC Microbiology team and the environmental and utilities monitoring, raw material testing, and final product testing.
Responsibilities include but not limited to:
** Supervision of all QC Microbiology laboratory testing**
• Sustain environmental monitoring programs.
• Management and optimization of the Aseptic gowning training and qualification program.
• Management of QC Microbiology training program.
• Works with QC raw materials team to establish specifications and testing process of raw materials.
• SME on investigations of sterility failures and environmental excursions.
• Monitor trend data
Assembles reports on findings from environmental monitoring of cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary.
•Completes routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
•Develops, revises and reviews SOPs, qualification/validation protocols and reports.
Conducts investigations regarding out of specifications (OOS) results and address and manage non-conformances related to micro procedures.
• Provides updates at daily and weekly meetings.
• Monitors the GMP systems currently in place to ensure compliance with documented policies.
• Reviews proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
• Gathers metric information for use in continuous improvement of areas of responsibility.
• Support regulatory inspections and audits
• Other related job duties as assigned.
NOTE: Shift may include weekends and second shift hours.
The pay range for this position at commencement of employment is expected to be between $88,000 and $132,000 year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
The Supervisor, Quality Control Microbiology, works with the Quality Control team in supporting our efforts of RLT therapy. This role is responsible for the day-to-day oversight of the QC Microbiology team and the environmental and utilities monitoring, raw material testing, and final product testing.
Responsibilities include but not limited to:
** Supervision of all QC Microbiology laboratory testing**
• Sustain environmental monitoring programs.
• Management and optimization of the Aseptic gowning training and qualification program.
• Management of QC Microbiology training program.
• Works with QC raw materials team to establish specifications and testing process of raw materials.
• SME on investigations of sterility failures and environmental excursions.
• Monitor trend data
Assembles reports on findings from environmental monitoring of cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary.
•Completes routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
•Develops, revises and reviews SOPs, qualification/validation protocols and reports.
Conducts investigations regarding out of specifications (OOS) results and address and manage non-conformances related to micro procedures.
• Provides updates at daily and weekly meetings.
• Monitors the GMP systems currently in place to ensure compliance with documented policies.
• Reviews proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
• Gathers metric information for use in continuous improvement of areas of responsibility.
• Support regulatory inspections and audits
• Other related job duties as assigned.
NOTE: Shift may include weekends and second shift hours.
The pay range for this position at commencement of employment is expected to be between $88,000 and $132,000 year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Diversity & Inclusion / EEO
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. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Role Requirements
Education:
Bachelor’s degree in relevant Microbiology discipline or equivalent practical experience in Supervision of Microbiology related activities including but not limited to EM monitoring and product testing for microbiology.
Languages: Fluent in speaking / writing in English
Experience / Professional requirements:
Minimum of 3 years’ experience in Quality Control in cGMP or aseptic environment required.
1 year experience supervising/managing/leading microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry.
Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
Ability to gown for entry into Aseptic core and supporting areas, and lift up to 25 lbs.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, cGMPs, microbiological method development and validation.
Strong data integrity knowledge and practices.
Identifying, writing, evaluating and closing OOS investigations. Strong knowledge of aseptic manufacturing and EM processes.
Experience in the application of microbiological techniques including rapid release methods, and qualifying EM processes.
Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
Good Knowledge of cGMP regulations and FDA guidance
Quality Control for product and Environmental Monitoring testing, Aseptic techniques, Analytical equipment.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
The 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 [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Bachelor’s degree in relevant Microbiology discipline or equivalent practical experience in Supervision of Microbiology related activities including but not limited to EM monitoring and product testing for microbiology.
Languages: Fluent in speaking / writing in English
Experience / Professional requirements:
Minimum of 3 years’ experience in Quality Control in cGMP or aseptic environment required.
1 year experience supervising/managing/leading microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry.
Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
Ability to gown for entry into Aseptic core and supporting areas, and lift up to 25 lbs.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, cGMPs, microbiological method development and validation.
Strong data integrity knowledge and practices.
Identifying, writing, evaluating and closing OOS investigations. Strong knowledge of aseptic manufacturing and EM processes.
Experience in the application of microbiological techniques including rapid release methods, and qualifying EM processes.
Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
Good Knowledge of cGMP regulations and FDA guidance
Quality Control for product and Environmental Monitoring testing, Aseptic techniques, Analytical equipment.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
The 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 [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
Indianapolis, IN
AAA USA Inc.
Quality
Full Time
Regular
No
