What are the responsibilities and job description for the Chief Operating Officer position at McGuff Companies?
About McGuff Pharmaceuticals, Inc.
McGuff Pharmaceuticals, Inc. is a family-owned, FDA-inspected sterile pharmaceutical manufacturer with a legacy spanning over 25 years and backed by over 45 years of operational excellence from our parent company. We are an FDA-registered pharmaceutical manufacturer, 503B outsourcing facility, and emerging CDMO, operating a brand-new, state-of-the-art facility in Southern California.
Our core capabilities include sterile injectable drug manufacturing from non-sterile bulk raw materials, on-site microbiology and chemistry labs, stability and process validation programs, and robust environmental monitoring. We support private practices across the country and are actively expanding into hospital systems, institutional buyers, and international markets.
We’ve recently completed multiple successful FDA inspections, and we’re entering our most ambitious chapter yet—with platform growth in NDA/ANDA submissions, IV admixture bag compounding, prefilled syringe development, and long-term CDMO partnerships.
Position Summary
We are seeking an accomplished, strategic-minded Chief Operating Officer (COO) to lead McGuff Pharmaceuticals into its next phase of growth. As the senior-most executive responsible for all operational aspects of the business, the COO will oversee Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Validation, Supply Chain, Engineering, and Laboratory Services.
This role is equal parts visionary and operator—requiring a dynamic leader who can set the direction for future growth (across product platforms, markets, and regulatory pathways), build internal capabilities, and ensure day-to-day operational excellence. The COO will be a key partner to the CEO and executive team, acting as a bridge between strategic intent and organizational execution.
Key Responsibilities
Strategic Vision & Growth Execution
• Set and execute the long-term operational strategy for McGuff Pharmaceuticals, Inc. in alignment with company-wide goals.
• Lead expansion into new markets and services, including:
o NDA and ANDA sterile injectable drug programs
o 503B compounded sterile drug innovations
o IV bag admixture services under 503B
o Ready-to-administer prefilled syringe platforms
• Guide the company’s evolution into a leading CDMO partner, overseeing client integration, tech transfers, and scalable process design.
• Identify future capabilities (e.g., automation, isolator technology, lyophilization) and ensure readiness for emerging industry needs.
Organizational Leadership
• Oversee all pharmaceutical manufacturing operations across departments, including full responsibility for compliance, performance, and delivery metrics.
• Foster a culture of excellence, quality, ownership, and patient-centered outcomes.
• Build alignment across diverse teams—from manufacturing floor to executive offices—around a unified operational vision.
• Own and drive regulatory compliance (FDA, DEA, state boards, international agencies), inspection readiness, and post-audit response execution.
Team Development & Culture Building
• Attract, develop, and retain high-performing talent across all operational departments.
• Establish clear expectations, coaching structures, and performance metrics to elevate execution at every level.
• Champion continuous learning, professional development, and succession planning to support long-term organizational growth.
External Representation
• Represent McGuff Pharmaceuticals in regulatory discussions, client audits, CDMO partnership negotiations, and investor or board-level meetings.
• Serve as an operational ambassador to customers, hospital networks, and regulatory agencies—instilling trust and reinforcing McGuff’s quality-first reputation.
Ideal Experience & Qualifications
Required
• 12 years in sterile injectable pharmaceutical manufacturing or CDMO leadership, including 5 years in an executive-level operational role (COO, SVP, Site Head).
• Direct experience leading FDA-inspected facilities (503B, NDA, ANDA, or parenteral manufacturing).
• Proven success scaling operations, introducing new platforms, and leading facility readiness for new market demands.
• Deep working knowledge of cGMP, aseptic processing, quality systems, and inspection protocols.
• Demonstrated ability to lead multidisciplinary teams and create alignment around long-term objectives.
Preferred
• Experience launching or scaling CDMO services.
• Prior involvement with hospital group purchasing organizations (GPOs) or institutional sales channels.
• Strong understanding of emerging sterile technologies (isolators, robotics, high-throughput filling lines, etc.).
• Advanced degree in pharmacy, life sciences, engineering, or related field (MS/PhD/PharmD preferred).
Key Leadership Attributes
• Vision-Setter – Able to define and communicate where the company is going and why it matters.
• Results-Oriented – Focuses on measurable outcomes, process performance, and patient impact.
• Builder of People – Invests deeply in talent, culture, and team capacity.
• Learning-Driven – Continuously explores new capabilities and encourages innovation.
• Unifier – Brings cross-functional teams together under a shared mission.
Why McGuff Pharmaceuticals?
• Lead a modern pharmaceutical manufacturing organization entering its most transformative era.
• Influence not just what we make—but how, why, and who we make it for.
• Join a company where family values, scientific excellence, and operational integrity are not just principles—they’re daily practices.
• Work with a seasoned executive team that values collaboration, growth, and bold leadership.