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 hypergrowth, I provide clear, actionable plans and unwavering support. As the architect of safe and compliant cGMP operations, I ensured that our facilities were always inspection-ready on a global scale.• 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, integrity, and collaboration• 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 roadmap, and impactful process improvements • 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 • Served as a Technical Subject-Matter-Expert (SME) to guarantee the swift, sound, and compliant investigations of non-conformance and phase II out of specification (OOS)• Reduced open production investigations from 450 down to 175 by:--- Identifying trends and consolidating investigations--- Restructuring team to be able to support events as they occurred--- Implementing procedural improvements for efficient handling --- Eliminating unnecessary delays in determining responsibility --- Streamlining investigation writing and aligned review process

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• Cryopreservation of materialDuring my short tenure with Sampled, I facilitated development and implemented monitoring of critical key performance indicators for sample processing, which led to the quick resolution of issues with identified with processing turnaround times. I also rolled out cross functional training of laboratory staff on critical procedures, allowing continuity of testing and flexibility in work assignments, which alleviated peak periods of sample processing. Moreover, I worked to establish relationships with clients and provide scientific and technical support ensuring growth of business.

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 newly approved cancer drug. I was accountable for daily release testing processes to ensure excellence in cGMP compliance and health authority regulations. Additionally, I led tactical initiatives for growth, which included expanding the team, identifying and capitalizing on growth opportunities, and optimizing efficiency, productivity, and cost-effectiveness in laboratory operations. I managed project scheduling, delegation of assignments, and continuous evaluation of team performance. Moreover, I directed all QC validations, transfers, investigations, and change control, while also overseeing the department budget.• 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 leveraging the success from my previous role to address a significant cultural problem within the team. I focused on fostering an environment where employees felt safe to speak up and where discrimination and favoritism concerns were eliminated. Additionally, I streamlined an inefficient scheduling model to improve overall efficiency and productivity.• 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 seasoned replacements, revitalizing workplace culture characterized by enhanced communication, idea-sharing, and morale • 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 Microbiology best practices, which led to the reduction of oversampling by thousands of sites, saving time and money• Introduced efficient processes, contributing to cost savings despite budget-driven layoffs • Entrusted as Subject-Matter-Expert, Scribe, and Host, supporting the backroom during audits and inspections• Pioneered the introduction of Lean Labs in the QC Microbiology department

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. Additionally, I led certified investigators in triaging and investigating QC deviations, OOS, OOT, and OOE events, ensuring robust CAPA implementation and providing necessary escalation when required. I also managed QC change control processes in compliance with guidelines, protocols, and cGMP requirements. Moreover, I owned the Laboratory Information Management System (LIMS), overseeing continuous improvement initiatives for over 800 users across multiple sites. I ensured enterprise system and equipment compliance for continuous lab operations and collaborated on workflow optimization, production qualifications, batch record revisions, risk assessments, environmental monitoring, and microbiological methodology improvements.• 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 patient samples, analytical chemistry testing, and radioactive isotope HPLC and ITLC. Reviewed analytical data and approved results of drug product, bulk drug substance, and intermediates tested. Manage the stability program and compose technical reports on trending, accelerated, in-use, and temperature excursion studies. Collaborated with members of the Regulatory Department to draft filings/amendments and annual reports.

Morris Plains, New Jersey, Us

Chicago, Illinois, Us

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

Bachelor Of Science - Bs, Biology, General