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.
Coordinates and supports 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.
Assesses 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.
Build and sustain common innovation roadmap between MSAT and Drug Product Manufacturing/Finishing to ensure continuum in innovation to accelerate client projects and sustainable process performance.
Lead the client technical intake process team composed of engineers and specialists.
Drive complex change management & anchor the changes in MSAT and with connected functions, Drug Product, Finishing, Quality Assurance and Quality Control
Responsible for exhibiting professional behavior with both internal and external business associates that reflect positively on the company and is consistent with the company's policies and practices.
Serves as key contact for clients during tech transfer and post manufacturing activities.
Serve as a senior consultant on complex issues.
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.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
Benefits
Vision insuranceEquity / stock options
Additional Information
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Sr. Director, MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our client intake process, tech transfer and subsequent manufacturing to various PCI teams, playing a vital role in securing the present-day operations, while delivering future clinical and commercial supply of high-quality and innovative drugs for incoming and existing clients. By driving process improvement, tech transfer and future transformation, the Sr. Director, MSAT fulfills an important function by providing day-to-day Manufacturing Support, effective Life Cycle management of equipment, process robustness enhancement, and yield improvement to optimize manufacturing performance across all modalities. This position drives the standardization, improvement and change management through the MSAT team to implement best-in-class practices in various field of activities across the PCI D&M segment. This position will also directly influence modernization effort at all Bedford facilities in alliance with site management ensuring robust GMP capability across manufacturing areas in support of the PCI long range plan.
Pciservices · Bedford, NH