Novartis
Supervisor, QC Chemistry
Novartis, Indianapolis, Indiana, us, 46262
Job Description Summary
Location: Indianapolis, IN #LI-Onsite
About this role:
In this people management role, the QC Chemistry Supervisor 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 Chemistry team including raw material testing and final product testing.
Job Description
Key Responsibilities: Supervision of laboratory personnel. Provide oversight for personnel work schedules as well as for scheduling and completion of testing and documentation. Provides oversight towards QC laboratory equipment maintenance. Expertise in one or more of the following methodologies: HPLC/UPLC, wet chemistry, TLC, endotoxin, radionuclidic identity by half-life, environmental monitoring, sterility Maintain the laboratory and laboratory procedures/processes in a constant state of inspection readiness. Ensure personnel are appropriately trained and cross-trained. Author, review, and approve technical documents. Ensure trending reports are completed and approved within established timelines. Support 5S and Lean Laboratory implementation and sustainability. Provide support of laboratory related manufacturing investigations, CAPAs, and change controls. Ensure safety requirements are met and maintained. Perform other job duties as assigned. Design and execute method transfers/qualifications/validations based on Regulatory guidelines and industry best practices. Collaborate with other groups to drive project success. Troubleshoot method challenges. Manage method development and optimization activities as needed. Essential Requirements:
BS or MS in Biology, Chemistry, Microbiology or other related science. Minimum of 5 years of relevant experience in the pharmaceutical, biologics, medical device, or advanced therapy medicinal products industry. Previous supervisory experience is recommended but not required. Working knowledge of aseptic manufacturing, cGMPs, GLPs and applicable compendial and regulatory guidelines (e.g. FDA, EP, JP) Thorough knowledge of analytical and microbiological test methods. Experience with LIMS.
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.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.
Salary Range $88,000.00 - $132,000.00
Skills Desired Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence
About this role:
In this people management role, the QC Chemistry Supervisor 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 Chemistry team including raw material testing and final product testing.
Job Description
Key Responsibilities: Supervision of laboratory personnel. Provide oversight for personnel work schedules as well as for scheduling and completion of testing and documentation. Provides oversight towards QC laboratory equipment maintenance. Expertise in one or more of the following methodologies: HPLC/UPLC, wet chemistry, TLC, endotoxin, radionuclidic identity by half-life, environmental monitoring, sterility Maintain the laboratory and laboratory procedures/processes in a constant state of inspection readiness. Ensure personnel are appropriately trained and cross-trained. Author, review, and approve technical documents. Ensure trending reports are completed and approved within established timelines. Support 5S and Lean Laboratory implementation and sustainability. Provide support of laboratory related manufacturing investigations, CAPAs, and change controls. Ensure safety requirements are met and maintained. Perform other job duties as assigned. Design and execute method transfers/qualifications/validations based on Regulatory guidelines and industry best practices. Collaborate with other groups to drive project success. Troubleshoot method challenges. Manage method development and optimization activities as needed. Essential Requirements:
BS or MS in Biology, Chemistry, Microbiology or other related science. Minimum of 5 years of relevant experience in the pharmaceutical, biologics, medical device, or advanced therapy medicinal products industry. Previous supervisory experience is recommended but not required. Working knowledge of aseptic manufacturing, cGMPs, GLPs and applicable compendial and regulatory guidelines (e.g. FDA, EP, JP) Thorough knowledge of analytical and microbiological test methods. Experience with LIMS.
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.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.
Salary Range $88,000.00 - $132,000.00
Skills Desired Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence