Resumé
Primary responsibilities for this position include performing tasks associated with in-coming material, in-process and release testing and reviewing laboratory data, coordinating the team/lab under its responsibility. Communicating with internal and external partners for the Quality Control organization. Supports site as technical expert in related field.
This role will support manufacturing operations which will require shift work and scheduling which will require weekend work.
Location: Carlsbad #CA-Onsite
This role is located on-site in Carlsbad, CA. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you.
About the Role
Key Responsibilities:
· Management of QC Analytical activities in line with site objectives. Coordination of departmental Operational activities. Track team metrics and ensure KQI /KPI meet requirements.
· Coordination of departmental Operational activities
· Initiate and drive local hiring process.
· Lead OpEx Projects.
· Investigation of Deviation, OOx, Complaints.
· Define and implement CAPAs.
· Support transfer Projects and validation studies.
· Track team metrics and ensure KQI /KPI meet requirements.
· HSE incidents reporting and action follow up.
· New equipment commissioning Support (OQ, PQ).
· Resource and capacity (people and equipment) planning and workload management.
· Performance and leadership support of QC Analytical team
· Ensure availability of equipment, chemicals and consumables, as appropriate.
· SOP review and revision.
· Ensure training according to cGxP requirements.
· Management of documentation and methods according to cGxP.
· Exception management.
· Ensure DI and compliance with cGxP and all regulatory requirements.
· Leadership in GxP audits and fulfillment of internal/external audit and inspection plans.
· Equipment qualification review /release.
· Ensure Methods and Procedures are up to date.
· Ensure qualification /calibration status of analytical equipment.
· Microbiological testing review and approval.
Work Experience:
· Analytical Validation
· Corrective and Preventive Action (CAPA) Knowledge
· Deviation Management
· Equipment Calibration Management
· Equipment Qualification Management
· Good Manufacturing Practices (cGMP)
· Audit & Inspection Management
· Quality Control
· Quality Management Systems
· Quality Control Microbiology
· Stability Management
· Laboratory Excellence
· SOP (Standard Operation Procedure) Management
· KPI Reporting
· Laboratory Excellence
Education and Knowledge:
· Bachelor's degree in Chemistry, Biology, or other relevant scientific discipline
· Minimum of 5 years of work experience in Quality Control of pharmaceutical products, preferably radiopharmaceuticals
· 2 years of experience in a people manager role
· Experience in managing a cGMP laboratory
· Knowledge of following analytical methods/equipment: HPLC, iTLC, Endotoxin, Bioburden, pH, NVP and viable particle counters
· Knowledge of FDA regulations regarding the manufacturing of radiopharmaceuticals
· Applied knowledge of GXP and EP/USP guidelines
The salary for this position is expected to range between $114,000 and $211,900/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. 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.
Accessibility & 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 [email protected] 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.
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