Job Description Summary
365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
The Manufacturing Operations Specialist is responsible for the dispensary / ISO8 area tasks including kitting and material flow, inventory management and other duties required to support the core functions
This role is located on-site in Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Location: Morris Plains, NJ, LI-Onsite
Shifts: PM shift- 3 positions available
Job Description
Key Responsibilities:
- Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance. Ensure accurate SAP/MES inventories are maintained for all components.
- Ensure Manufacturing Support areas are maintained in an “audit ready” state.
- Ensure equipment cleaning and maintenance is performed per governing SOP requirements.
- Escalate any observed compliance or safety issues and support reconciliation of event.
- Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc.
- Support monthly and annual cycle count and support all site/team projects and initiatives.
- Coordination of receiving, storage and processing of materials.
- Ensure inventory accuracy of GMP and non-GMP LN2 storage locations.
Dispensary / ISO8 Activities:
- Ensure accurate SAP/MES inventories are maintained for all components.
- Ensure proper status segregation and storage of all conditioned and ambient materials.
- Ensure Kanban system is accurate, and materials are consumed per FEFO/FIFO.
- Ensure kitting/staging of initial kits are complete for each shift and timely response to kitting requests for production.
- Monitor staged kits for expired materials and to ensure utilization prior to expiry.
- Ensure all gowning materials in the ISO8 staging area are maintained to adequate levels.
- Ensure dispensary area has ample supply of non-BOM items.
Essential Requirements:
- 1+ years of related experience in cGMP/FDA regulated industry. High School degree required. Bachelor's degree preferred.
- Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required.
- Must be well organized, flexible and work with minimal supervision.
- Ability to lift up to 50 lbs., assisted.
- Requires handling of chemicals such as corrosives, solvents & bio-hazardous material
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $30.57 and $56.82/hour. 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.
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 e-mail to us.reasonableaccommodations@novartis.com 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.
Salary Range
$52,400.00 - $97,400.00
Skills Desired