12,000. The number of associates worldwide working together to reimagine medicine!
The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.
The Senior Expert Science & Technology (GMP Testing), collaborates closely with Process Development, Analytical Development, Quality and other teams to develop, qualify, automate, transfer and improve analytical methods.
Your responsibilities will include, but are not limited to:
• Serves as SME in several assays, such as NGS, ddPCR, ELISA, AUC, UPLC, potency, and other cell and gene therapy analytics.
• Plays a leadership role in site lab operations to support development of new gene therapy medicines.
• Routine sample testing under GMP modes, laboratory maintenance, and participating in method qualification, automation, transfer, and improvement.
• Reviews and trends testing results.
• Leads assay troubleshooting, critical reagent qualification, method qualification, validation, and transfer.
• Manages the procurement, implementation, use, and maintenance of equipment, instrumentation, and computer systems.
• Writes and revises documents such as specifications, protocols, and reports.
• Leads investigations to determine root cause of atypical or OOX results.
• Identifies and implements new technologies to improve efficiency and compliance in operations.
• Represents analytical operations to work with other departments including Analytical Development, Quality Assurance, and Process Development to address compliance issues and to implement corrective actions and to improve programs.
• Other related duties as assigned.
Diversity & Inclusion / EEO
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.
What you'll bring to the role:
• Bachelor's degree in Chemistry, Biology or related scientific field and 6 years of industry experience or Associate's degree with 10 years equivalent experience.
• 5 years in GMP Quality Control laboratory.
• Extensive knowledge of GMP principles.
• Excellent oral and written communication skills with strong technical writing experience required.
• Potential for up to 20% travel .
• Possess strong understanding of testing operations and provide expertise in several assays, such as NGS, ddPCR, ELISA, AUC, UPLC, potency, and other cell and gene therapy analytics.
• Ability to work independently on problem solving, lab investigations, and implementation of preventative and corrective actions.
• Ability to work effectively within the group, within Analytical Development, Quality, Regulatory, Process Development, and across sites.
• Highly motivated and solution-driven with ability to succeed in a dynamic and growing Quality Control (QC) team.
• A thorough understanding of FDA/EMEA regulation.
The pay range for this position at commencement of employment is expected to be between $102.400 and $153,600/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.
766 million lives were touched by Novartis medicines in 2021, 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!
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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.