7! The number of projects you will oversee as the new Manufacturing Expert based at the Novartis Pilot Facility in Fort Worth, TX. As part of the Technical Research & Development team, this role is critical in making sure that sterile clinical supplies are manufactured to the highest quality aseptic standards, ensuring our patient safety in clinical trials.
Your responsibilities include, but are not limited to:
Collaborate with project and operations teams by providing technical expertise and direction in cGMP processes and procedures of aseptic production for the successful completion of each batch of clinical supplies.
Represent the Pilot Facility as the single point of contact for technical / capabilities discussions and play an integral role in manufacturing readiness to ensure that the team is adequately prepared to proceed with production.
Lead all investigations related to all aspects of aseptic production of clinical supplies. These activities range from the incoming receipt of raw materials to the shipment of primary packaged drug products. You will lead the team through the discovery phase for root cause analysis, assist with definition of appropriate CAPAs and finally define effectiveness checks to prevent future repeat incidents.
Collaborate with QA and project teams in the timely completion of batch record documentation, with strict adherence to GDP and cGMP, and ensure the safety and efficacy of each batch prior to release for use in patients.
Suggest and execute productivity enhancements to allow for more efficient batch production that does not sacrifice quality or safety. Compile and present lessons learned from each manufacturing campaign.
Work according to all SOPs, cGMP, Quality Manual, Quality Directive, Health Safety & Environmental and Novartis guidelines. Maintain processes at inspection readiness level and provide the necessary support in any internal or external audit.
What you'll bring to the role:
What you will be to the role:
An advanced degree in pharmaceutical, life sciences or equivalent. PhD, PharmD is preferable. Fluent English (oral and written)
Minimum of 3 years where you have successfully demonstrated competency in a similar role either working in an aseptic manufacturing plant making clinical or commercial drug products.
Thorough knowledge of state-of-art instrumentation/equipment for aseptic production of simple solution, complex suspensions, and emulsions. Experience in non-sterile topical production instrumentation is also beneficial.
Strong communication skills. Strong presentation skills and scientific/technical writing skills. Advanced coaching and servant leadership skills.
You will receive:
Competitive salary, annual bonus, health insurance, xx days leave, flexible working arrangement options, employee recognition system. Find out more about Novartis: https://www.novartis.com .
Why consider Novartis?
750 million. Thats how many lives our products touch. And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more peoples lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where youre given opportunities to explore the power of digital and data. Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Fort Worth, TX
Global Drug Development
TECHNICAL R & D GDD
EEO Statement 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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.