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.

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.

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.

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.

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.

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.

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.

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.

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..

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.

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.

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.

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

Graduate Study Toward Phd, Chemical Engineering