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Associate Director Clinical Processing Unit Cell Therapy

United States
Closing date
Sep 24, 2023

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Job Description

2,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

What you will be doing:

You will Coordinate, schedule and lead all activities related to clinical manufacturing for the Cell and Gene Technical Development and Manufacturing Pilot Plant at East Hanover. Lead a group of manufacturing associates and support personnel to produce GMP material for early clinical trials as well as technical batches. Lead projects as per site priorities. Grow and develop the team to support the planned increase in manufacturing capacity.

• Accountable for manufacturing activities of CAR-T processes ensuring execution of processing according to GMP guidelines to meet timelines and demand of clinical programs. Has oversight into activities and is involved in strategic decision making.
• Ensures cGMP compliance of all GMP operations and quality of intermediates or finished products.
• Upholds a multi-product approach to enable the success of the clinical pipeline.
• Supports the development, revision, application, maintenance, validation and review of quality standards, documents, and methods for processing.
• Supports process transfer activities and related documentation authorship or revision (i.e., Batch Record, SOP, WP, etc.).
• Reviews and approves development protocols and summary reports, performs comparability assessments to support CMC fillings.
• Leads optimization of manufacturing procedures to improve efficiency in close collaboration with the technical development and validation team.
• Act as project lead for portfolio programs to represent the Pilot Plant.
• Performs review and release of completed batch records and forms.
• Additionally, maintains GMP and GLP systems and environment, as well as ensures that all safety requirements are met for the lab areas.

The pay range for this position at commencement of employment is expected to be between $144,200 and $216,000 year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you'll bring to the role:
• BS/MS in engineering, biology, chemistry, biochemistry, microbiology, or other related science
• English
• Minimum of 6 years of experience in pharmaceutical/biotechnology industries conducting GMP manufacturing and development.
• Minimum of 3 years in a leadership or people management position with successful performance and track record in the role of line/people manager in R&D, GMP environment or a related industrial area.
• Cell and Gene Therapy experience strongly preferred.
• Knowledge of cGMP, USP, FDA and EU guidelines.
• Excellent communication, presentation, and organization skills.
• Has exceptional people management skills.
• Knowledge and familiarity of SAP systems, including Quality Module (QM), LIMS (Labware LIMS), Trackwise, eSOPS and SubWay.
• Strong ability to work independently, compliantly and results driven.
• Strong analysis and decision-making skills surrounding documentation.
• Pays attention to detail.

Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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 e-mail to [email protected] 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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