Manufacturing Process Expert

Job Description Summary

Job Description

Your responsibilities include, but are not limited to:

• Support a culture of safety, quality, diversity, and inclusion.
• Provide front line support to manufacturing shifts to ensure safe, quality, and timely completion of product batches.
• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Track and trend critical process parameters and in process checks as the lead for ongoing process verification (OPV) and identify CAPAs to address any trends.
• Identify, assess, and own technical changes through GMP change control processes.
• Investigate deviations and determine root causes and identify CAPA.
• Act as Subject Matter Expert (SME) for the product and process knowledge and provide input to the Annual Product Review.
• Ensure processes are inspection ready at all times.
• Support continuous improvement through identification of opportunities, technologies, and owning changes to implement improvements.
• Support validation protocol generation and execution.
• Support on going self-learning and ensuring training is up to date.
• Provide guidance and support to production team through training and knowledge sharing.

• This position will involve wearing protective clothing and working in a Manufacturing Grade C clean room environment.
• This position may require shift work including weekends and off hours support.
• Strong interpersonal, written, communication skills along with problem solving and follow-up skills.
• Well organized, flexible and work with minimal supervision.

Essential Requirements:

• BS degree in life sciences, engineering, chemistry, biotechnology, or related field or equivalent relevant experience
• Training in radiochemistry or radio pharmacy is an preferred
• 4 or more years' experience in GMP operational roles with direct experience in pharmaceutical manufacturing, specifically low bioburden manufacturing preferred
• Involvement with quality regulatory inspections of facilities from major agencies such as FDA or EMA.
• Shows the appropriate sense of urgency around given tasks
• Strong change management skills, adaptability, and the ability to work under pressure.
• Proficient technical writing skills.
• Good understanding of manufacturing and validation requirements and activities.
• Radiation safety education (desired).
• Leverage new technologies and techniques to eliminate non-value adding activities and improve productivity / performance through new processes.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $84,000 and $126,000/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, 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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.

Salary Range

Skills Desired