Stephen Sanders Email & Phone Number

Broomfield, Colorado, United States

Thornton, Colorado

Senior Project Manager in the pharmaceutical and biotechnology industry serving clients in the United States and abroad. Areas of expertise include:• Technical (engineering lead), vendor, client and third-party management• Develop and maintain strong collaborative relationships with project resources and stakeholders• Perform Engineering assessment (Engineering Design Reviews) and remediation • Develop and manage project scope of work and budgets• Drive Issue assessment, resolution and implementation in collaboration with stakeholders• Maintain project metrics, prepare and present monthly reports for senior client management• Prepare project budgeting, staffing and coordination plans• Lead and manage project close-out activities• Develop and implement risk assessment and mitigation plans• Perform facility assessments and audits, including technical design review (project and site)

Frederick, Co

Manage third party manufacturing relationships, internal manufacturing operations, engineering, quality, production planning, and logistics for $2.5M food supplement manufacturer selling to international wholesalers, distributors, and via e-commerce.• Led company efforts to enter $4B market and expand portfolio by spearheading development of company’s first NSF-certified product, including quality, R&D, third party manufacturing, product testing and packaging design.• Manage third party manufacturing relationships, internal manufacturing operations, engineering, quality assurance and quality control.• Increased product yield and batch consistency by optimizing manufacturing process.• Realized significant cost savings by revising production processes to increase key ingredient content by 33%, effectively boosting product potency.• Successfully hosted several rigorous FDA audits, with no recorded action items and no lost production time or finished goods, by maintaining continuously compliant facilities. • Strengthened team performance, cohesion, and project buy-in by creating a collaborative team charter to clarify project objectives, establish milestones, and foster lasting motivation. • Reenergized team morale, collective progress, and individual performance by integrating regular, enjoyable team building activities on particularly demanding projects.

Frederick, Co

• Managed all internal GMP manufacturing operations, developed strategic manufacturing plan for new and existing products, sourced and commissioned new equipment, and maintained USDA and FDA compliance.• Reduced costs and improved manufacturing cycle times by executing performance metrics and reporting system.• Developed corporate quality policies and programs, enforced raw material and finished product specifications, performed internal and third-party facility audits, and remediated manufacturing problems.• Promoted to Senior Operations Manager after only 6 months of employment.

Boulder, Co | Raleigh, Nc

Senior consultant for $15M global engineering design and consulting firm providing process system design, FDA compliance, and equipment commissioning & validation services to global clients.• Analyzed and remediated manufacturing processes, providing intensive client advisement.• Led highly successful $200K project, completed 20% under budget and 20% ahead of project deadline by implementing testing strategy that streamlined new equipment integration process.• Managed engineering and project budgets up to $250K for biotech and pharmaceutical industry leaders including Genentech, Bayer, Wyeth and Merck.• Developed engineering and QA programs including analyzing technical data and implementing solutions based on client needs and regulatory requirements.

Raleigh, Nc

• Drove 133% increase in regional consulting staff, growing number of FT employees from 3 to 7 during tenure by personally recruiting, training, and evaluating new team members.• Developed business plan for SE regional office, establishing and managing client relationships across the region• Managed all budgets (up to $300K), deliverables, and schedules for client projects.• Represented company at regional industry trade shows and exhibitions.

Raleigh, Nc

• Led or supported consulting teams in analyzing manufacturing process or equipment issues, equipment commissioning, technical design review, and manufacturing process evaluation for global clients.• Recognized for role on cross-functional team that converted animal health facility to human oncology drug production facility on schedule and budget.• Worked internationally in Spain for 9 months.

Raleigh, Nc

• Managed team responsible for collecting, evaluating and maintaining project documentation generated by sub-contractors for new $300M manufacturing facility, including tracking project milestones and budget.• Standardized project documentation requirements, developed expedited work flow processes to meet project deadlines.

Validation Associates, Inc. | Washington Group International | Serentec, Inc.

Bachelor Of Science (B.S.), Chemical Engineering

Master Of Business Administration (Mba)