Novartis Hiring for AS&T Manager, Quality Control job in Millburn Full Time

Job Description
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 AS&T Manager will be responsible for leading and ensuring site technical development of quality control methods/processes, method and instrument validations, and technical transfers associated with Analytical and/or Microbiological quality control testing of product, raw materials, and packaging components. This role is also responsible for operation/maintenance of quality control instrumentation in accordance with cGMP/FDA regulations, AAA standard operating procedures and policies. Due to the nature of the process (radioactive) this role also requires proficiency of quality control techniques, analytical instrumentation, sterility principles, and understanding of radiation safety standards.

Responsibilities include but not limited to:
• Oversee all technical aspects related to quality control testing development, including QC method and instrument qualifications as well as technical transfers from third party laboratories or other Novartis/AAA sites.
• Manage and support method and instrument implementation, including Change Control execution, qualification/validation protocols, and document revisions, while developing the skills of their team for career growth.
• Keep up with industry trends and best practices. Drive spirit of continuous improvement to ensure Inspection readiness state.
• Subject matter expert for Raw Material and Finished Product testing, Environmental Monitoring and Sterility QC testing, and reporting of the QC results. Provides technical insight for escalations in case of non-conformances and deviations and manages these quality incidents as per Novartis/AAA procedures.
• Oversee stability testing program at Millburn facility.
• Collaborate with Global organization to resolve any analytical testing problems, recommend appropriate changes, if required.
• Conduct or delegate AS&T specific investigations, including OOS/OOT/OOEs and deviations. Ownership and/or oversight of AS&T based CAPA implementation.
• Select, train, support AS&T personnel in quality control testing development. Staff performance management and development.
• Act as designee and make key decisions regarding quality control processes in the absence of the QC Head.
• Facilitates a culture of “speaking up” and ensuring all cGMP compliance activities are followed.
• Supports internal and external Audits and Inspections, acting as an AS&T subject matter expert.

The pay range for this position at commencement of employment is expected to be between $102,400 and $153,600 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.

Minimum requirements
Education: Minimum of a Bachelors’ degree in relevant Science Analytical testing or Microbiology discipline.

Language: Fluent English Required

Minimum of 5-7 years’ experience in cGMP or aseptic environment Quality Control is required.

Practical experience in Analytical Chemistry techniques and/or Microbiology techniques.

Solid Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for products, Environmental Monitoring testing, Aseptic techniques, and Analytical equipment.