Sr Material Excellence Engineer LCM
About The Position
The Senior Material Excellence Engineer LCM is to lead global implementation of critical material projects that will drive reliability, innovation and sustainability in our processes and plants across the globe, both internally and externally. The successful candidate is therefore able to appropriately balance the requirements at all manufacturing sites as it relates to multiple in-flight programs/indications: early development, clinical trials, and commercial activities. The capability to effectively facilitate change activities including the ability to navigate within a global network and collaborate effectively with internal and external partners will be key to drive critical programs to successful completion. This role will work in a cross functional setting and must have strong communication skills to foster collaboration and drive success across the organization. Up-to-date knowledge of industry standards, regulatory requirements and pharmaceutical manufacturing processes related to cellular therapies are highly desirable
Requirements
- A minimum Bachelors Degree and/ or equivalent; required
- Minimum 6 years of relevant experience and BS degree OR 4+ years with advanced degree MS/MBA/Ph.D.
- Experience working in a pharmaceutical environment
- In depth working knowledge and conversant with cGMP guidelines and Health Authority regulations (EMA, FDA, etc.)
- Project Management skills and the ability to interface cross-functionally with other areas of expertise
- Understanding of drug development, manufacturing processes and submission requirements
- Ability to work independently and in a matrixed team environment
- Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution
- Strong written and verbal English skills
Nice To Haves
- Competency and experience with introduction of biological products to manufacturing sites
- Cell/ gene therapy or material experience
Responsibilities
- Collaborate with cross-functional teams to optimize network performance and ensure the highest standards of quality and compliance.
- Implement standard processes for supply chain management, logistics, and distribution to enhance operational effectiveness.
- Identify and Lead to process improvements projects, including new materials or technologies to deliver innovations and increase the reliability of our processes and plants.
- Develop and monitor key performance indicators (KPIs) to track operational performance and identify areas for improvement.
- Work closely with the production and manufacturing teams to optimize resource utilization and reduce costs.
- Drive organizational change by implementing effective change management strategies and communication plans.
- Identify potential risks and develop mitigation strategies to minimize disruption to operations.
- Assess and implement local changes based on global initiatives/product strategy.
- Understand operational network differences and enable efficiencies across the network, where appropriate.
- Continuously monitor/analyze manufacturing performance and design projects/initiatives to enable manufacturing performance, cost reduction, and process robustness objectives
- Support the creation of business cases for ongoing improvement projects, including risk management, financial analyses, and regulatory compliance assurance.
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
