Susan Lopez Ninichuck Email & Phone Number

Dublin, CA, US

Foster City, CA, US

Boston, Massachusetts, US

• Developed and executed a 'Lab of the Future' strategy at Foundation Medicine, focusing on modernizing lab testing technology.
• Implemented lab testing automation and digital conversion, reducing sample TAT to <7 days.
• Achieved yoy COGs reduction target through strategic initiatives.

South San Francisco, California, US

• Led quality operations for US clinical supply of Roche biotechnology pipeline, ensuring regulatory compliance.
• Implemented fit-for-purpose PQS approaches to meet regulatory requirements and enhance product lifecycle.
• Transformed quality organization of South San Francisco Campus into end-to-end clinical-only development and production site in 2022.

Indianapolis, Indiana, US

• Established a virtual, cross-functional support team to ensure Roche's cloud-based software products comply with IVDR regulations.
• Implemented end-to-end technical support for Roche's innovative cloud-based digital operations, facilitating successful product launches.
• Developed an internal Development Opportunity website to promote cross-training and resource sharing within the organization.

Switzerland 🇨🇭, CH

• Developed and executed a Quality Strategy aligned with market practices and regulatory trends.
• Led a regulatory compliance recovery effort resulting in successful FDA/EMA inspections.
• Implemented Lean Labs initiative to streamline processes and improve productivity.

Switzerland 🇨🇭, CH

• Led a new Quality Assurance team overseeing pharmaceutical APIs and reagent manufacture, ensuring 'planned and predictable' product supply.
• Managed a quality compliance recovery crisis, addressing over 1.5K regulatory risks at the site.
• Authored a Quality Master Plan (QMP) to enhance compliance and reputation with global Health authorities.

Deerfield, Illinois, US

• Led a team of scientists and engineers in developing and qualifying plasma-derived parenteral biologic therapies.
• Co-led the development, scale-up, and launch of an orphan botulism antibody drug operations.
• Designed and constructed an 8.5K square foot non-GMP facility with manufacturing scale-down equipment and an analytical laboratory.
• Collaborated with external agencies for plasma collection and establishment of fill/finish operations.

Deerfield, Illinois, US

• Led a team at Baxter BioScience in developing small-volume, parenteral, plasma-derived biologic products.
• Supported lifecycle management and CMC deliverables for INDs, BLAs, and Health Authority information requests.

St Paul, MN, US

• Managed product lifecycle of small molecule inhalation drug delivery products for asthma and COPD treatment.
• Oversaw introduction of new products and directed manufacturing technical development team for scaling up an asthma inhaler.
• Developed Master Validation Plan and Cleaning Validation program for the facility, executing validation protocols.

St Paul, MN, US

• Implemented Six Sigma methodology at a pharmaceutical manufacturing site, training and coaching over 200 Green Belt candidates.
• Established a project management process, managed the plant's Six Sigma project portfolio, and led Black Belt level projects with savings exceeding $1M each.
• Accountable for meeting cost, cash, and growth targets of over $2M annually.

St Paul, MN, US

Columbia, MO, US

B.S., Chemistry

Genetics And Genomics Certificate

Ph.D., Inorganic Chemistry