Location: Indianapolis, IN #LI-Onsite
About this role:
In this people management role, the AS&T Supervisor will coordinate method optimization and compliance activities within the Quality Control department as well as support development, validation, and external activities as needed.
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.
Commitment to Diversity & Inclusion:
We 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.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Role Requirements
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.
The pay range for this position at commencement of employment is expected to be between $88,000.00 and $132,000.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards
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.
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 hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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