Key ResponsibilitiesCommercial Manufacturing Ownership
- Serve as the single point of accountability for assigned CMOs supporting commercial product manufacturing and packaging operations.
- Ensure on-time, in-full (OTIF) delivery of commercial supply, meeting demand forecasts and inventory targets.
- Own production planning alignment with Supply Chain, including capacity planning, campaign scheduling, and inventory optimization.
- Proactively identify supply risks and lead mitigation strategies to ensure uninterrupted commercial supply
External CMO Management & Governance
- Lead day-to-day operational oversight of CMOs, including production performance, issue resolution, and escalation management.
- Establish and maintain robust governance processes (KPIs, business reviews, scorecards, and continuous improvement plans).
- Drive vendor performance management, including quality, cost, delivery, and reliability metrics.
- Partner with Procurement on contracting, scope definition, and cost optimization initiatives.
Technical & CMC Leadership
- Provide technical oversight of commercial manufacturing processes, ensuring consistent product quality and performance.
- Support and oversee technology transfers, process validation, scale-up, and lifecycle management at external sites.
- Lead or contribute to complex investigations, root cause analyses, and implementation of CAPAs.
- Champion process robustness and continuous improvement initiatives across CMOs.
Quality & Compliance
- Ensure all manufacturing activities comply with cGMP, regulatory filings, and quality agreements.
- Collaborate closely with Quality Assurance on deviations, change controls, CAPAs, and audit readiness.
- Support health authority inspections and ensure effective response to regulatory observations (if applicable).
- Maintain compliance of technical documentation and manufacturing records.
Cross-Functional Integration
- Partner with Supply Chain, Quality, Regulatory, Technical Development, and Commercial teams to align manufacturing operations with business priorities.
- Ensure seamless communication of manufacturing performance, risks, and supply outlook to leadership.
- Support launch readiness and ongoing lifecycle management for commercial products.
Regulatory Support
- Contribute to CMC sections of regulatory submissions (NDA/ANDA variations, annual reports, supplements).
- Ensure manufacturing processes and changes are aligned with global regulatory requirements.
Position RequirementsMinimum Qualifications- Bachelor's degree in Chemical Engineering, Pharmacy, Chemistry, or related discipline.
- 7+ years of experience in pharmaceutical manufacturing, technical operations, or CMC.
- Demonstrated experience managing external CMOs for commercial drug product and/or packaging operations.
- Strong knowledge of cGMP regulations, commercial manufacturing operations, and tech transfer and process validation.
- Proven ability to manage cross-functional teams and external partners.
Preferred Qualifications- Advanced degree (MS, PhD, MBA).
- Experience with commercial small-molecule products (solid oral dosage and/or sterile).
- Experience supporting regulatory filings and health authority inspections.
- Strong track record in commercial supply chain management and vendor governance.
- Experience in lifecycle management and post-approval changes.
- Proven success managing complex supply chains in a matrixed environment.
Key Competencies- Strong ownership mindset for commercial supply reliability
- Excellent vendor and stakeholder management skills
- Ability to operate in a fast-paced, matrixed environment
- Strategic thinking with strong execution discipline
- Effective problem-solving and decision-making under pressure
Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship.
The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees.
