Aseptic Process Expert Lead - (Day shift)

**378314BR** **Job ID:** 378314BR **About the role:** Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE). 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 Aseptic Process Expert Lead provides direct front line support to production activities using technical understanding and knowledge of cGMPs, SOPs, and process steps with a focus on aseptic technique and sterility assurance. This individual is accountable to support process issues, protocol generation, general documentation support, deviation investigations, and continuous improvement of the process related to sterility, environmental monitoring, and aseptic practices. Your responsibilities include, but are not limited to: •Act as site Subject Matter Expert for Media Challenges, Bioburden studies, Smoke Studies, Disinfectant testing, Aseptic Manipulations, aseptic behaviors and management, and Gown Training. •Advise the Site Lead Team on the Sterility program, champion and own any recommendations for improvement of the Contamination Containment Strategy. •Actively leads and supports investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA. •Supports regulatory audits as Aseptic Sterility Assurance subject matter expert. •Organize front line support to manufacturing shifts to ensure safe, quality, and timely completion of product batches in an aseptic manner and assuring sterility of the product. •Manage and maintain manufacturing documentation including Aseptic Process Simulation protocols (Media Fills), sterility risk assessments, Contamination Containment Strategy, and other associated documents. •Lead a team of 3 Aseptic Process Experts supporting sterile operations. •Manage the Aseptic Training Program and provide training to aseptic operators. •Analyze and write reports with conclusions and recommendations based to the Site Lead team based on data. •Own or support EM data gathering, trending, and alert levels. •Support a culture of safety, quality, diversity, and inclusion. Please note: This position will involve wearing protective clothing and working in a Manufacturing Grade C clean room environment. The pay range for this position at commencement of employment is expected to be between $107,200 and $160,800 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. \n\n\n\n **Position Title:** Aseptic Process Expert Lead - (Day shift) **Role Requirements:** What you’ll bring to the role: • Bachelor’s degree in Microbiology or another scientific discipline (preferred) or equivalent experience •5+ years of experience in a GMP environment •4+ years of experience in a support of Aseptic Processing •2+ years of experience supporting Sterility Assurance programs for aseptic manufacturing facilities •Prior experience with FDA and EMA regulations and regulatory inspections •Ability to work in a cross functional team •Excellent communication skills •1+ year of experience leading a small team preferred or demonstrated leadership potential •Technical writing experience preferred •Radio pharma experience is a plus •Understanding of Microbiology is a plus •Word, Excel, Powerpoint, and Teams Experience **Job Type:** Full Time **Country:** USA **Work Location:** Indianapolis, IN **Functional Area:** Technical Operations **Division:** Operations **Business Unit:** Radio Ligand Therapy **Employment Type:** Regular **Company/Legal Entity:** AAA USA Inc. **Commitment to Diversity & Inclusion::** _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._ **Shift Work:** No **Early Talent:** No