Director Cell and Gene Therapy Analytical Operations
Director Cell and Gene Therapy Analytical Operations
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$ 176400 - 327600
1 Vacancy
Job Description
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Level 6Job Description Summary
Position: Director Cell and Gene Therapy Analytical OperationsLocation: East Hanover NJ United States (Onsite)
Join Our Vision: At Novartis we are on a transformative journey in cell and gene therapy pushing the boundaries of medical innovation. We are currently seeking an experienced and visionary Director to lead our Cell and Gene Therapy Analytical Operations Team. In this critical role you will support both cell therapy and gene therapy clinical products and oversee the Bioanalytics Microbiology Instrument & GDLIMS as well as the Raw Material sample Management and Stability teams. Your expertise will play a crucial role in ensuring the quality and compliance of our cell and gene therapy products.
As the Director for Cell and Gene Therapy Analytical Operations you will play a critical role in ensuring the quality and safety of our cell and gene products in the clinical phase. Reporting directly to the Head of Cell Therapy Analytical Development and Operations you will provide strategic leadership and technical expertise to the Analytical Operations team. Through effective management and collaboration with crossfunctional teams you will establish and maintain robust quality control processes to meet regulatory requirements and support the companys goals in advancing cell and gene therapy manufacturing.
Job Description
Key Responsibilities:
- Lead a large Cell and Gene Analytical Operations organization 40 associates) providing guidance mentorship and strategic direction to ensure the successful of quality control activities.
- Develop and implement quality control strategies systems and procedures to support the development manufacturing and release of clinical cell and gene therapy products in compliance with regulatory requirements.
- Oversee subteam activities including routine testing method qualification / validation / transfer environmental monitoring stability new instrument onboarding and LIMS build.
- Ensure compliance with current Good Manufacturing Practices (cGMP) industry standards and regulatory expectations for quality control operations.
- Collaborate closely with crossfunctional teams including Analytical Development Pilot Plant Manufacturing Technical Operations Quality Assurance Regulatory CMC and Facility and Engineering to ensure effective coordination and alignment of quality control activities.
- Drive continuous improvement initiatives identifying and implementing innovative technologies process enhancements and best practices to optimize efficiency and ensure product quality.
- Lead and manage investigations related to outofspecification (OOS) and outoftrend (OOT) results deviations ensuring timeline resolution and implementation of appropriate corrective and preventative actions (CAPAs).
- Track metrics for invalid assays and lead the team to perform analytical method trending to ensure consistent quality and identify areas for optimization.
- Support regulatory agency inspections and audits respond to any observations or findings and drive the implementation of corrective actions.
- Ensure proper documentation practices and data integrity in compliance with regulatory expectations and company policies.
- Plan and manage departmental resource and budget.
Requirements:
- BS with a minimum of 15 years in biopharmaceutical industry.
- Minimum of 8 years experience in quality control.
- Minimum of 5 years of experience in direct people management.
- Indepth knowledge in Cell and Gene product testing methods such as qPCR/dPCR/ddPCR ELISA NGS flow cytometry potency liquid chromatograph and microbiology methods.
- Strong understanding of cGMP regulations industry standards and regulatory expectations for cell and gene therapy quality control.
- Demonstrated leadership experience including managing and developing highperforming teams.
- Excellent organizational skills with the ability to prioritize and manage multiple projects simultaneously.
- Effective communication and interpersonal skills with the ability to collaborate and influence crossfunctional teams.
Desirable Requirements:
- Experience with electronic systems such as SAP LIMS and Quality Management Systems.
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 and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: to Diversity & Inclusion: 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.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $176400$327600/year; however while salary ranges are effective from 1/1/24 through 12/31/24 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 signon 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 atwill 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.
Join our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: 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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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 email to calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Agility Agility Business Acumen Business Partnering Business Strategy Clinical Clinical Trials Continued Learning Dealing With Ambiguity Decision Making Skills Drug Development Employee Performance Evaluations Health Authorities Influencing Skills Inspection Preparedness Knowledge Of Gxp Leadership Organizational Savvy People Management Problem Solving Skill Qa (Quality Assurance) Quality Management Research Risk Management Root Cause Analysis (RCA) 4 moreRequired Experience:
Director
Employment Type
Full-Time
