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 to cancer patients. We are looking for experienced Manufacturing and Quality Assurance professionals to help us reach our ambitious goals.
Key Responsibilities:
• Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators using vaporized hydrogen peroxide. Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
• Maintains and prepares equipment/environment for use
• Assist on deviation investigations and inspections
• Participation in assigned qualification/validation activities, as necessary
• Performs production of each individual customer product vial in a highly classified isolator cell while ensuring the sterility of the injectable drug product. This includes dispensing vials, removing those vials using a delivery system and preparing vials for shipment.
Additional Notes:
• This position involves shift work and has a 4 day 10-hour work schedule Sunday – Wednesday Night shift.
• This position will involve wearing protective clothing and working in a Manufacturing environment.
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
• Bachelor’s degree in a STEM field (Science, Technology, Engineering & Math) is preferred; If the applicant does not have a degree, a minimum of 1-year of experience in cGMP or aseptic environment is required.
• Ability to effectively use MS office suite – Excel (Spreadsheet), Word (Document writing and completion) and Outlook (Email and Calendar).
Experience & Requirements
• Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing is highly preferred
• Ability to gown aseptically and work in a clean room environment (Grade C) area for extended periods of time is required
• Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role
• Prepares and qualifies equipment for use on a daily basis by executing performance testing and a myriad of daily checks to ensure that equipment is sterile, sealed and operating normally in order to ensure patient safety
• Prepares applicable documents and records such as batch records, shipping documents, and training materials
Desirable Requirements:
• Previous Radio pharma experience a plus
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: People and Culture | Novartis.
Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $27.40 and $41.15/hour; 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.
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
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: Novartis Talent Pool.
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