Summary
About the Role
Key Responsibilities:
- Lead and Facilitate Work Cell meetings. Ensures the Work Cell achieves targets for Quality, Safety and Productivity (Production throughout times and batch record review). Compiles area metrics, reports, and performance levels as required. This may include reporting to higher level Management.
- Craft Module schedule to ensure business needs are achieved while balancing personnel scheduling adjustments.
- Maintaining a daily physical presence with direct reports in the module on and off the shop floor to supervise, coach and support.
- Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time.
- Provide support to all employees in the area to ensure they are equipped with all tools, training, and documentation to perform their tasks. Ensure associates are demonstrating the proper aseptic techniques & behaviors.
- Adhere to all SOPs, cGMPs, and safety rules and regulations and ensure associates are executing tasks per approved policies and applicable procedures.
- Work with team to resolve tactical issues and facilitate Corrective Actions and Preventive Actions (CAPAs).
Shift: This position is a PM Shift (12pm-10:30pm) Sunday- Wednesday located on-site at our Morris Plains, NJ facility.
Essential Requirements:
- Bachelor’s Degree is required. BS/BA degree in Biotechnology, Biopharmaceutical, Pharmaceutical Technology, Chemistry, Microbiology, Pharmacy, or other Life Science-related scientific degree is preferred.
- A minimum of 3 years’ experience in cGMP
- At least 1 year of Lead/supervisor experience
- Proven process understanding (Pharma, GMP, Regulatory aspects)
Desirable Requirements:
- Cell therapy manufacturing highly desirable
- Project management, Operational Excellence, Product/Process Development or Regulatory experience is desired.
The pay range for this position at commencement of employment is expected to be between $88,000 to $132,000 a 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 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.
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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
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