Andy Howard Email & Phone Number

Denver, CO, US

San Diego, California, US

• Led the implementation of a large-scale processing equipment project, ensuring timely delivery and adherence to budget constraints.
• Directed commissioning, qualification, and validation (CQV) activities for QC, warehouse, and manufacturing systems, ensuring operational excellence and regulatory adherence.
• Orchestrated technology transfer activities, including GMP readiness and QMS compliance, aligning with ICH Q7 guidelines.

Basel, Baselstadt, CH

• Conducted comprehensive product and process characterization at both commercial and benchtop scales, enhancing understanding of product performance and scalability.
• Analyzed data and presented findings to global network teams, driving informed decision-making and process improvements.
• Led multiple experiments supporting clinical and commercial product campaigns, contributing to the development and optimization of production processes.
• Contributed to the implementation and scale-up of single-use suspension bioreactors, improving efficiency and reducing contamination risks in bioproduction.

• Conducted thorough deviations investigations, identifying root causes and implementing corrective and preventive actions (CAPAs) to enhance process integrity.
• Led cross-functional problem-solving groups, utilizing root cause analysis tools to address and resolve complex operational issues.
• Authored SOPs, technical reports, and protocols with high proficiency, ensuring clarity and compliance with regulatory standards.
• Provided technical support during compliance audits, facilitating smooth audit processes and maintaining adherence to industry regulations.

• Supervised the production of liquid oligo products and associated reagents, ensuring adherence to quality standards and production schedules.
• Assisted in implementing new equipment and process improvements, optimizing manufacturing efficiency and productivity.
• Drafted and revised batch records and SOPs under tight deadlines, maintaining accuracy and compliance with regulatory requirements.

Denver, Colorado, US

• Led the production team in manufacturing, packaging, and shipping of all products.
• Executed stability and design experiments, resulting in improved product quality.
• Maintained compliance documents and databases for finished goods and raw materials.

Thousand Oaks, CA, US

• Performed cell culture and protein purification operations at the pilot and commercial scale.
• Led process characterization campaigns in collaboration with process engineers.
• Wrote and revised critical procedures and protocols.
• Scheduled daily tasks for floor staff, maintaining project timelines and workload balance.

Thousand Oaks, CA, US

• Managed scheduling and workload balancing as shift lead.
• Conducted chromatography operations for multiple commercial drug products with zero production losses.
• Skilled in chromatography column packing and integrity analysis testing.