Process Lead (Relocation Assistance)
Resilience
Summary
Accountable for driving standardization of practices and continuous improvement across the Process Execution Team (PET). This individual will serve as a Process SME for the IDAP or Sterile Ops PET, advising, and leading by example in areas including tier communication processes, efficient operation, line clearance, changeover, SAP transactions, training, deviation and change control management, and other areas as needed. Additionally, through a focus on LEAN and Problem Solving the Process Lead will help the PET Lead drive performance improvements.
Job description
Job Responsibilities
- Works with teams to develop standards/standard work for line set-up, center lining, troubleshooting, etc.
- Partner with area technical team on mistake-proofing/design improvements for the lines and processes
- Leverages performance data (e.g., KPIs, OEE, Yields, Downtime) to drive improvement across all shifts/lines.
- Understanding regulatory and company global standards and potential gaps, then driving implementation to close gaps
- Process confirmation and drive a common approach across all lines/shifts.
- Drive an increased focus on problem solving - both in timeliness and quality (we will not stop until we have identified and addressed the root cause)
- Spend ≈20% of time on the floor.
- Actively driving continuous improvement and standardization
- Involved in regular Genba walks ensuring actions are recorded for process improvement and coaching is provided to area operators.
- Manages deviation and change control records as needed and tracks progress of quality records to completion.
- Provides training to colleagues in technical writing, Veeva navigation and process flow.
- Leads bi-weekly Staff meetings in collaboration with the PET Lead
Education, Qualifications, Skills, and Experience
Minimum Requirements
- Considerable experience in GMP or regulated production environment
- Experience in a manufacturing or operations-based field/industry involving a fast-paced, customer-oriented environment.
- Experience coaching and influencing others to drive performance.
- Experienced in demonstrating skills in the areas of asking questions, listening, providing feedback, self-awareness.
- Display of Leadership capabilities that support customer focus, integration of diverse views, ability to make decisions under pressure, and develop an objective view of others’ capability to provide coaching and feedback in the moment and continually develop his/herself.
- Working knowledge of Veeva Vault and data analysis tools such as Excel and PowerBI
- Flexibility to adjust shift schedule to support 24/7 operations.
- Ability to direct self and others in a project environment
- Ability to coach and mentor peers.
Preferred Background
- Bachelor’s degree in engineering or a related science
- Advanced technical degree or professional certification
- Pharmaceutical Industry experience
- Knowledgeable in change management
- Uses their insight to challenge and adapt current approaches/ways of doing things.
- Experience in Six Sigma/analytical troubleshooting skills
- Experience working in a LEAN manufacturing environment.
Requirements
- Considerable experience in GMP or regulated production environment
- Experience in a manufacturing or operations-based field/industry involving a fast-paced, customer-oriented environment
- Experience coaching and influencing others to drive performance
- Experienced in demonstrating skills in the areas of asking questions, listening, providing feedback, self-awareness
- Display of Leadership capabilities that support customer focus, integration of diverse views, ability to make decisions under pressure, and develop an objective view of others’ capability to provide coaching and feedback in the moment and continually develop his/herself
- Working knowledge of Veeva Vault and data analysis tools such as Excel and PowerBI
- Flexibility to adjust shift schedule to support 24/7 operations
- Ability to direct self and others in a project environment
- Ability to coach and mentor peers
- Bachelor’s degree in engineering or a related science
- Advanced technical degree or professional certification
- Pharmaceutical Industry experience
- Knowledgeable in change management
- Uses their insight to challenge and adapt current approaches/ways of doing things
- Experience in Six Sigma/analytical troubleshooting skills
- Experience working in a LEAN manufacturing environment
Benefits
- Annual cash bonus program
- 401(k) plan
- Company match
- Medical insurance
- Dental insurance
- Vision insurance
- Family building benefits
- Life insurance
- Disability insurance
- Paid vacation
- Paid holidays
- Paid leaves of absence
- Tuition reimbursement
- Caregiving support
Company overview
Resilience (National Resilience, Inc.) is a technology-focused contract development and manufacturing organization (CDMO) 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 that advanced therapies can be made quickly, safely, and at scale. Resilience specializes in manufacturing complex modalities including biologics, vaccines, nucleic acids, cell and gene therapies, and drug products. With facilities across North America, the company partners with leading biopharma companies to bring innovative medicines to market faster and more reliably. Their capabilities span biologics drug substance manufacturing, cell-based therapies, and aseptic drug product manufacturing for both small and large molecules. Resilience's mission is to free its partners to focus on scientific discoveries while advancing the science of biopharmaceutical manufacturing through cutting-edge technologies and integrated digital systems.