RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.
For more information, visit www.resilience.com.
Position Summary & Role:
The Senior Quality Control (QC) Scheduler, reporting to the Director of Quality Control, will create Quality Control schedules to ensure efficient operations, meet testing timelines and maximize available capacity in the QC laboratories at the Resilience Philadelphia site. The Senior QC Scheduler will collaborate with departments inside and outside the organization to ensure full alignment with company objectives and priorities.
The Senior QC Scheduler will take into account quality control testing timelines and capacities, head count, equipment availability and other parameters that influence scheduling constraints. The Senior QC Scheduler will also take responsive action as a result of revisions to the manufacturing production schedule, product development schedule and subsequent implementation strategies, and business continuity risks.
Your responsibilities will include, but are not limited to:
- Create and maintain detailed schedules for quality control operations including release and characterization testing for both vector and cell therapy manufacturing batches to meet defined Turn-Around Time (TAT).
- Quickly respond to last minute changes in manufacturing productions to achieve alignment for an updated schedule
- Coordinate QC analysts training with the development teams for training of new methods.
- Schedule method qualification activities in support of new client projects.
- Manage the QC testing schedule for stability programs and ensure stability testing window requirements are met.
- Coordinate and execute sample management activities, including but not limited to, sample receipts, transfers and shipments.
- Closely work with QC leadership to support Supply Chain & Operational Performance (S&OP) by evaluating site level QC capacities, operational capabilities and supply requirements (i.e. material availability status, future needs evaluation).
- Coordinate and schedule general laboratory activities such as, but not limited to, equipment maintenance activities and laboratory cleaning, while striving to maintain minimal impact to testing schedule.
- Lead/coordinate assigned functional sub-teams; participate in function-specific teams and fulfil assigned project tasks and responsibilities under minimal supervision.
- Identify and drive operational excellence and continuous improvement opportunities.
- Complete all required job specific cGMP, Data Integrity, and EHS trainings and adhere/comply to appropriate standards defined for quality, ethics, health, safety, environment, and information security.
- Understand the requirements, expectations and needs of internal and external customers and interact in courteous, professional, supportive, and collaborative manner.
- Bachelor of Science degree in Supply Chain, Engineering, Life Sciences, Information Systems, Computer Science, Business Management or related technical field. A combination of relevant education and experience will be considered in lieu of degree.
- 4+ years of Logistics, production planning/scheduling experience in a Biotech or pharmaceutical industry
- Knowledge and experience with cGMP Quality Systems including LIMS.
- Experience with cell and gene therapy QC testing requirements and timelines
- Experience with managing stability programs
- Knowledge and experience with scheduling systems
Other Ideal Personal Characteristics:
- Demonstrated ability to take ownership, initiative, and self-accountability
- Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting
- Attention to detail and quick learning/application of concepts and information
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $85,000.00 - $111,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.