Sr Director, MSAT

Key Responsibilities

• Optimize the use of resources (human, fill finish equipment and support areas) across the organization in support of improving process robustness and forward-looking capabilities.
• Covers coordination and support of cross-functional teams with recommendations, advice, and action plans for complex investigations, change controls, gap analyses and risk assessments related to all manufacturing modalities.
• Oversees authoring and revision of compliance, change controls and other technical documentation to support critical MSAT changes.
• Affirms incoming client projects to ensure compatibility, compliance, and initial and ongoing profitability with AAI processes.
• Contributes advanced level support to internal and client audits when needed.
• Builds and sustains common innovation roadmap between MSAT and Drug Product Manufacturing/Finishing to ensure continuum in innovation to accelerate client projects and sustainable process performance.
• Leads the client technical intake process team composed of engineers and specialists.
• Drives complex change management & anchors the changes in MSAT and with connected functions, Drug Product, Finishing, Quality Assurance and Quality Control.

Requirements

• 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.

Equal Employment Opportunity (EEO) Statement
P业Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.