Steve Speer Email & Phone Number

San Diego, CA, US

La Jolla, CA, US

cGMP Quality Systems for Neoantigen, CAR-T, and gene therapy immunotherapy, personalized precision medicine; RNA Replicon

Raleigh, North Carolina, US

Comprehensive GxP compliance and management consulting; program management, project management; Drug/device development processes and technology transfer strategies; GxP compliance; regulatory affairs; corporate compliance; post-market surveillance; computer system validation; commissioning and qualification, information technology validation, Process.

Carlsbad, CA, US

Own the quality system; Transition from paper based quality system to electronic document management system; Obtained ISO13485 certification

Raleigh, North Carolina, US

Strategic project and program management; Business Development

Waltham, MA, US

• Established QC function as a stand-alone entity. Implemented QC concepts, philosophy, tools, and methods into the organization where they had not previously existed.
• Using lean and six-sigma toolbox, saved company money and time by improving product first time QC acceptance rates resulting in increased product flow, reduced manufacturing cycle times and improved schedule adherence.
• Introduced manufacturing and quality approach using High Performance Work Teams (HPWTs). Organization continues to harvest productivity gains and other cost savings as the HPWTs continuously identify and correct.
• On a daily basis, performed outside QC sphere by serving as one of three managers responsible for guiding the entire manufacturing organization towards accomplishing its goals in alignment with corporate.
• Hired by Life Technologies in 2005 specifically to build the capacity to manufacture selected reagents, proteins and nucleic acids in a cGMP environment. Led a project by which cGMP manufacturing capabilities were.
• The fully validated cGMP facility earned FDA licensing and ISO13485 certification within five months of the project’s completion date.

Waltham, MA, US

• Responsible for managing manufacturing process of the active pharmaceutical ingredient (API is an RNA aptamer used against age-related macular degeneration) at Eyetech’s contract manufacturer’s site in Edmonton.
• Responsible for managing process and product validation batches used as the basis for FDA pre-approval inspection (PAI) requirements. The product (Macugen) was the first ever oligonucleotide approved by FDA for.
• Developed multi-layered and highly detailed process maps used in PAI submission.

• Designed and managed construction of 20,000 sq. ft. manufacturing facility including Class 1000 clean rooms for products related to drug discovery and high throughput screening technologies.
• Authored numerous SOPs, raw material specifications, validation protocols and batch production records.
• Implemented Quality System “de novo” designed to comply with QSR and ISO requirements.
• Established technology transfer objectives and criteria from assay/process development to manufacturing. Managed pilot plant and new process development activities.
• Established standard cost system and implemented enterprise business information software including MRP module.
• Responsible for management of the following functions: cell culture, DNA synthesis, organic synthesis, lyophilization, bulk formulation, fill and finish, packaging, materials management, validation, facilities.

Emeryville, California, US

• Senior Manager, DNA Synthesis\Mfg. Operations\Senior Project Manager.
• Designed and managed construction of a manufacturing facility capable of satisfying FDA ELA requirements.
• Managed 45+ scientists and technicians responsible for manufacturing diagnostic assays and biopharmaceutical (fermentation) products.
• Managed OEM contract manufacturers responsible for supplying auxiliary instrumentation.
• Successfully managed several projects including development of analytical methods to support validation protocols, implementation of MRP and customer service software, process and facility validation.
• Primary Project Manager for the successful transfer of DNA probe and other technical manufacturing processes from Emeryville, CA to Walpole, MA.

CA, 92121, US

• Supervisor/Manager, Component Manufacturing/DNA Synthesis
• First manufacturing person hired at Gen-Probe at “start-up” stage. Developed manufacturing processes, documents and compliance systems.
• Managed various manufacturing teams including DNA synthesis, bulk formulations, fill and finish, labeling and packaging.
• Established quality metrics and continuous improvement system for various manufacturing groups.