Associate Director Rapid Sterility
Associate Director Rapid Sterility
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$ 145600 - 270400
1 Vacancy
Job Description
Job Description Summary
Location: East Hanover New Jersey on siteDepartment: Cell Therapy Analytical Development and Operations
Position Overview:
Bench to bedside! We are seeking a highly motivated and experienced Associate Director to lead the development and implementation of rapid sterility methods for our cell therapy programs. This role is critical for enabling faster batch release and will significantly impact the success of our cell therapy products. The successful candidate will work closely with cross functional teams including Development Operations Quality Assurance Regulatory and Manufacturing to ensure the timely delivery and release of highquality cell therapy products. This individual will uphold Novartis Values & Beliefs and Code of Ethics to successfully support our bold mission of delivering effective CART cell products for patients in need.
Job Description
Key Responsibilities:
- Lead the design development validation and implementation of rapid sterility testing methods for cell therapy products.
- Develop and optimize procedures for sterility testing to ensure compliance with regulatory standards and guidelines.
- Collaborate with Regulatory CMC team to prepare and review regulatory submissions and responses related to sterility testing methods.
- Serve as subject matter expert in sterility testing providing guidance and support to project teams and stakeholders.
- Drive continuous improvement initiatives to enhance sterility testing efficiency and reliability.
- Conduct risk assessments and implement mitigation strategies for sterility testing processes.
- Stay current on industry trends advancements and regulatory changes related to sterility testing and cell therapy.
- Establish and maintain relationships with external vendors service providers and regulatory agencies.
- Prepare and present technical reports summaries protocols and standard operating procedures (SOPs).
Qualifications:
- Bachelors degree M.S. or Ph.D in Microbiology Cell Biology Biotechnology or a related discipline with a proven track record. Advanced education degree is preferred
- At least 8 years of experience in industry academia or relevant experience
- Strong understanding of regulatory requirements for sterility testing in the cell therapy industry (e.g. FDA EMA ICH guidelines) is required
- Strong ability with self directed learning to figure things out by reading scientific papers keeping up with industry trends and understanding regulatory guidance
- Excellent technical leadership skills with a team player mentality.
- Demonstrated ability to work independently and as part of a multidisciplinary team.
- Excellent problemsolving skills and the ability to handle multiple projects simultaneously.
- Strong written and verbal communication skills with the ability to clearly present complex scientific data to various audiences.
Preferred Qualifications:
- Experience in cell and gene therapy product development and manufacturing
- Knowledge of rapid microbial detection systems and advanced microbiology techniques.
- Familiarity with statistical analysis for method validation
- Prior experience working with health authorities or regulatory inspections related to sterility methods
- Industry experience in the development and implementation of rapid microbiology assays for routine batch release
- Proficiency in the development validation and implementation of testing methods in a GMP environment is highly desirable
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $145600$270400; 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 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.
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 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 email to or calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$145600.00 $270400.00Skills Desired
Budget Management Coaching Skills Data Science Experiments Design Laboratory Problem Solving Skills Process Simulation R&D Waterfall ModelRequired Experience:
Director
Employment Type
Full-Time
