Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.
- Optimize the deployment of technical resources, manufacturing assets, and support functions across the network to maximize capacity utilization, process robustness, operational efficiency, and future growth capabilities.
- Provide strategic leadership and technical oversight for complex investigations, change controls, risk assessments, and gap analyses across all manufacturing modalities, ensuring consistent execution and regulatory compliance throughout the organization.
- Establish and govern standards for technical documentation, change management, technology transfers, and compliance-related activities supporting critical MSAT and NPI initiatives.
- Lead technical and business assessments of new client opportunities to ensure strategic fit, technical feasibility, regulatory compliance, capacity alignment, and long-term profitability across the network.
- Serve as the technical escalation point for major client engagements, regulatory inspections, and customer audits, providing expert guidance on complex manufacturing and process challenges.
- Develop and sustain an integrated innovation and technology roadmap linking MSAT, NPI, Engineering, and Manufacturing to accelerate commercialization, improve process capability, and advance future manufacturing technologies.
- Lead the cross-functional client technical intake and governance process, aligning commercial, technical, quality, and operational stakeholders to support successful project selection and execution.
- Drive enterprise-wide change management initiatives, ensuring alignment and adoption across MSAT, NPI, Manufacturing, Engineering, Quality Assurance, Quality Control, and Supply Chain functions.
- Act as the executive technical sponsor for strategic technology transfers, process performance improvements, lifecycle management initiatives, and network harmonization efforts.
- Serve as a senior technical consultant and subject matter expert on complex operational, process, and client-related challenges across the organization.
- Foster a culture of collaboration, technical excellence, innovation, and client focus while maintaining the highest standards of professionalism and compliance.
- Represent the organization during client interactions, governance forums, technical reviews, and executive leadership discussions involving product transfers, manufacturing readiness, compliance strategy, and process improvement initiatives.
- Develop and maintain strong collaborative relationships with internal stakeholders and external partners to ensure successful execution of technical and business objectives.
- Ensure compliance with all applicable PCI policies, cGMP regulations, quality standards, and Environmental Health and Safety (EHS) requirements.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable of performing the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.
- A frequent volume of work and deadlines may impose strain on a routine basis
- Minimal physical effort is required
- Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.
Work Environment: The work environment characteristics described here are representative of what an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Effective verbal and written communication with both internal and external contacts is critical to success. Interacts with members of the leadership team and may present to the Board of Directors as required.
- Must be able to interact effectively with internal and external clients.
- Oversees a wide array of subordinate managers, supervisors, and operations employees.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree in Life Sciences or equivalent experience required.
- Minimum of fifteen (15) years of relevant experience in cGMP manufacturing or equivalent.
- Proven experience leading innovation, managerial experience with extensive industry knowledge and an eye towards future technologies.
- Soft skills: Strategic thinking, adaptive thinking, and strong critical mindset. Strong business acumen and presentation skills. Excellent interpersonal, leadership, and communication skills. Impact & influence top leaders & external clients and regulators.
- Emphasis on aseptic processing and compliance required.
- Advanced-level verbal communication skills.
- Directs and provides expert knowledge of MSAT strategies, standards, and processes to support technology transfer, new product introduction (NPI), process
- Identifies, recruits, and retains top-notch talent.
- Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
- Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
- Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
- Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.
- Provides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.
BenefitsFor candidates in San Diego, CA, the hiring range for this position is $223,840 - $255,000 annually, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k)
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