Laura Wilde Email & Phone Number

Lawrence Township, NJ, US

• I led the charge in developing and implementing a strategic vision and roadmap to optimize the investigations process for cell therapy products in commercial manufacturing. Guiding teams through a period of.
• Directed and strengthened a cross-functional team of 45 investigators, both directly and indirectly, proactively turning around and driving culture improvements to effectively instill a sense of shared ownership.
• Achieved outstanding results in audits & inspections, with a 100% success rate and 0 remediation requirements, improving compliance of investigations through driving a substantial culture shift, effective project.
• Drove the integration of the Site MSAT Investigations team into cross-functional business units, fostering active participation in collaborative root cause analysis and implementation of effective CAPAs
• Transformed organizational roles and streamlined investigation processes, specifying team responsibilities
• Addressed concerns identified in employee satisfaction surveys, initiating Accountability and Integrity workstreams to enhance communication and foster a safer, more collaborative work environment

Piscataway, New Jersey, US

• I was responsible for overall operations and development of the Cell Processing Lab ensuring highest quality biomaterials and sample processing for the following services:
• Manual Peripheral blood/bone marrow mononuclear cells (PBMC & BMMC)/CD19 isolation
• Automated PBMC isolation using Hamilton easyBlood robotics platform
• Lymphoblastoid cell line (LCL) isolation with or without feeder layer
• Serum or Plasma isolation
• Cell line expansion

Basel, Baselstadt, CH

• I oversaw the strategic direction of the Quality Control department, leading a team of 20 direct and indirect reports through major growth and company restructuring to facilitate a significant production ramp-up of a.
• Transformed the QC organization to meet increased production demand for a second approved cancer product, expanding the team from 10 to 20 and restructuring testing workflows and scheduling
• Led accelerated testing, release, and production processes in a critical situation with a 36-hour product expiration, fostering team dedication through morale boosting and providing additional support during operations
• Led FDA remediation, achieving 100% compliance with 21CFR Part 211 by raw materials testing, audit trail review deployment, and sterility assurance
• Improved material qualification compliance by the successful implementation of three-lot testing and evaluation before reducing from full testing for each lot, ensuring Part 211 regulations
• Enhanced sterility assurance program by improving compliance in media fill and growth promotion testing procedures, material and equipment

Basel, Baselstadt, CH

• I led quality control operations management and spearheaded a culture transformation for the Microbiology organization, overseeing a team of 65 personnel as well as 7 direct reports. My responsibilities included.
• Overhauled testing schedule of products, reducing time turnaround time and strategically transitioning 2 of 7 tests to more fit departments, improving efficiency and team morale
• Drove site production ramp up, onboarding and restructuring workflows and scheduling to meet demand while reducing hours worked per day, increasing employee satisfaction, productivity, and efficiency
• Uncovered critical culture failures and identifying areas of opportunity, including:--- Recognizing and facilitating transition of employees to more suitable positions, boosting their job satisfaction --- Hired.
• Improved contamination control strategy by re-evaluation of facility EM sampling sites and frequency, implemented more frequent trending of EM, and enhanced training of production and QA shop floor staff on.
• Introduced efficient processes, contributing to cost savings despite budget-driven layoffs

Basel, Baselstadt, CH

• I managed short- and long-term strategic plans for the QC Support department, overseeing a 20-person team with 6 direct reports. My role involved ensuring prioritized resources for QC-related projects and initiatives..
• Expanded team for production capacity increase from 4 to 20 to support QC projects, electronic system data management, change control, and QC investigations
• Accelerated investigation timelines by centralizing the process, relieving analytical teams from the burden of conducting investigations themselves
• Led and fortified change management implementation, incorporating risk assessments and ensuring compliance
• Scaled electronic system to 800+ users from 100, ensuring validation, CFR Part 11 compliance, and contingency planning.

Morris Plains, New Jersey, US

Oversaw daily testing operations and release for the Quality Control department for raw materials, intermediates, APIs, and drug product including contract testing oversight and cell bank testing. Set daily testing assignments for scientists, specifically cell-based assays, IEF and SDS testing, Pharmacokinetics and Immunogenicity testing of clinical.

Morris Plains, New Jersey, US

Chicago, Illinois, US

Master Of Science - Ms, Cell/Cellular And Molecular Biology

Bachelor Of Science - Bs, Biology, General