Melissa Weakly Email & Phone Number

Austin, Texas, Us

Assisting Natera with evaluation and mitigation of current reagent QC methods and specifications in preparation for clinical assay validation.

Consulting and contract work for biotech and reagent manufacturing for medical diagnostics. Available for short- and long-term contracts, specializing in GMP and CLIA-compliant processes. Services include:- Evaluation of manufacturing quality systems for ISO 13485, 21 CFR 820 and IVDR compliance;- Assistance with the transition of reagent manufacturing from LDT to IVD support;- Authoring or revision of policies, standards and procedures to implement a streamlined and compliant process performance and product quality monitoring quality system;- Use of risk management tools to create new process control strategies, or to evaluate existing strategies for improvement and cost savings;- Other services upon request.

Seattle, Wa, Us

At Adaptive, I built and led the Manufacturing function, implemented new processes and systems to support ISO 13485, 21 CFR 820 and IVDR compliance, and transformed Manufacturing operations from an LDT-based organization to a GMP manufacturing group providing high quality reagents for the clonoSEQ IVD. My department was responsible for:- Manufacturing all reagents used to support Adaptive's diagnostic assays- Kit packaging and labeling development and manufacturing management, covering Adaptive and CMO operations- Design Transfer / New Product Introduction for new products and kits, and change management for existing products- Ownership and management of the Device Master Record (DMR) for Adaptive's clinical assays- Ownership and management of product quality specifications for reagents, raw materials, controls and kits.

Paris, France, Fr

The Genzyme Quaity organization enlisted my help with optimization of their commercial Process Control Strategy (PCS). In this capacity, I:- Created a playbook that laid out the steps for assessing control strategy optimization- Performed ROI calculations demonstrating financial justification for the project- Evaluated data and testing changes via risk assessment (pFMEA)- Articulated regulatory and implementation strategies for PCS optimization projects.- Facilitated a project as a case study for the approach: - Completed the risk assessment of a bioburden testing strategy that justified a 34% reduction in testing. - Developed a customized FMEA tool to evaluate the changes. - Created a template for other product teams to follow.

Established Littlewoods Consulting LLC to provide the following consulting services to clinical and commercial biopharmaceutical operations:- Evaluation of existing quality systems against effective regulations, with delivery of an action plan to address gaps;- Evaluation of existing control strategies in the context of clinical phase, production, commercialization and regulatory situation, with the goal to either 1) ensure the clinical product is on track to support successful validation and commercialization, or 2) identify opportunities to optimize the testing on commercial products; - Author or revise policies, standards and procedures to implement a streamlined and compliant process performance and product quality monitoring quality system;- Lead a project to optimize product testing, from data assessment through regulatory filing;- Other services upon request.

Created a Quality Plan to develop and implement a Quality Management System to support Phase 1 clinical through commercial manufacturing operations at Just's Seattle and China locations. Authored a Quality Manual to cover Just's global operations.

Thousand Oaks, Ca, Us

Co-led a special project to evaluate and optimize the control strategy testing on legacy commercial products. Optimized control strategies for legacy products had the potential to reduce testing up to 80% and to save the company tens of millions of dollars upon full implementation. We were responsible for:- Working with product teams and statisticians to identify opportunities to reduce testing, using historical data sets, cross-product knowledge, characterization data and appropriate statistics;- Collaborating with Reg Affairs to prepare and file optimized testing submissions; - Working with Analytical Sciences/QC to identify and implement modernized and more efficient testing methodologies; - Developing and managing project plans to drive all the analysis and filing activities and report progress to senior management;- Developing and implementing a strategy for changing specifications, In-Process Controls (IPCs) and stability protocols as regulatory approvals were obtained. Led the development and implementation of a new process for the quarterly reporting of manufacturing process capabilities (measured via Ppk) to Operations management. Amgen aspires to six sigma performance, and the report was used to identify improvement opportunities and track progress toward the six sigma goal.

Thousand Oaks, Ca, Us

Led the Process and Product Performance Global Network. Network consisted of representatives from all Amgen manufacturing sites, corporate and impacted functional areas and was responsible for setting standards, governing and improving corporate programs. Directed the department for Process and Product Monitoring and Controls, responsible for owning and managing the following corporate quality systems:- Annual Product Quality Review- Management Review- Specification and In-Process Controls (IPCs) Led a project to define and implement a new Continued Process Verification (CPV) program to meet 2011 FDA Process Validation guidance.

Thousand Oaks, Ca, Us

Directed the Product Quality Operations department, responsible for the business office, infrastructure and tactical support for the Product Quality Leader (PQL) role. My department also owned the following corporate programs: - Specifications and In-Process Controls (IPCs)- Process and Product Monitoring programs- Quality Risk Management- New Product LaunchI also represented Quality on a cross-functional team formed to define newly evolving Quality By Design (QbD) and Continued Process Verification (CPV) requirements.

Thousand Oaks, Ca, Us

Directed the corporate Validation department, owned the Validation quality system and acted as Global Network Leader for Validation activities at Amgen. In addition, my department owned and managed the following corporate programs: - Specifications and In-Process Controls (IPCs)- Annual Product Review- Product Comparability

Thousand Oaks, Ca, Us

Directed the Product Quality Operations department, responsible for the business office, infrastructure and tactical support for the Product Quality Leader (PQL) role. My department also owned the following corporate programs: - Specifications and In-Process Controls (IPCs)- Annual Product Review - Product ComparabilityIn addition, I led projects to define and implement the following programs:- Product quality requirements for comparators used in clinical trials- Non-routine sampling and testing of registered products- Residual solvent assessment and control to meet USP <467> requirements- Regulatory reserve sampling to meet Annex 19 requirements

Thousand Oaks, Ca, Us

Defined, recruited staff and led a new clinical Product Quality department responsible for coordinating all the critical product quality activities associated with early phase product development.Developed and implemented a resource model, project plan and data acquisition tool for Product Quality support of products, from pre-clinical through validation. Resource model was used to plan and allocate Quality resources to new pipeline products. The project plan and data acquisition tool became the main project management tools for clinical Product Quality Leaders.

Thousand Oaks, Ca, Us

Defined, recruited staff and led a new Quality Engineering department responsible for providing statistical and QE services to the Amgen Thousand Oaks operations site.

Thousand Oaks, Ca, Us

Lead Business Analyst for monitoring programs on team that designed and implemented Amgen's new LIMS system.

Thousand Oaks, Ca, Us

Led Amgen's first tech transfer of a bulk biotech process to a contract manufacturer.

Thousand Oaks, Ca, Us

Defined, recruited staff and led a new department of process engineers responsible for all technology transfers and direct product support for clinical and commercial manufacturing at Amgen Thousand Oaks. Department transferred over 30 bulk manufacturing processes between the pilot plant and GMP manufacturing facility, or between GMP facilities. Product campaigns spanned Phase 1 through validation and product launch of Aranesp. My group was also responsible for process validation, specifications, in-process controls, process change control and regulatory filings.Developed and implemented Amgen's first formal technology transfer process. Presented Amgen's program at external conferences.Led a team of engineers that created corporate design standards for fermentation and purification production equipment. (2000)

Indianapolis, Indiana, Us

Directed operations at Lilly Research Lab's Advanced Bioreactor Facility. Collaborated with scientists and engineers at Lilly Research Labs and global manufacturing facilities to identify opportunities for technology development and to develop innovative solutions with a focus on process control technologies and instrumentation for fermentation and deep tank cell culture.

Indianapolis, Indiana, Us

Provided technical services support to fermentation operations at Tippecanoe Laboratories.Led Lilly's first recombinant fermentation scale-up and tech transfer to a contract manufacturing facility. Received Lilly Research Labs Associates Recognition Award and Quality Advocate Award for leadership of the effort to evaluate and implement a new recombinant strain for a legacy product. The new strain resulted in reduced cycle time and improved yield.

Bachelor’S Degree In Chemical Engineering, Biotechnology Interdisciplinary Major, Minors In Math And Biochemistry

Graduate Study Toward Phd, Chemical Engineering