Associate Director, Process Operations Lead

* Strategic member of the capital project delivery project team providing Operational knowledge & leading efforts in Operational Readiness to deliver and stand up a new GMP clinical facility.
* Lead a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-market for future Clinical campaigns.
* Oversee the coordination efforts for Drug Substance Manufacturing Execution (Shop Floor Operations) intended to meet the requirements of New Product Introduction (NPI) schedule.
* Manage the Operations team, which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies.
* Drive operational excellence for Right First Time (RFT) batch execution.
* Oversee production planning and associated activities, integrated with the NGB Multiproduct platform.
* Ensure operational readiness in cross-functional partnership with other key stakeholders, as required by each Tech Transfer program to the facility. This involves engaging cross-functionally to deliver site-based activities related to the program. Designing a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA).
* Accountable for the management of GMP systems in support of operations.  Develop future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.
* Collaborate across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.
* Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
* Prior experience of operations team management and monitoring performance.
* Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing.
* Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for operations.
* Experience with facility fit assessments, New Product Introduction, transfer of processes to and from clinical site, and clinical manufacturing experience.
* Delta V and MES (Manufacturing Execution System) knowledge and experience
* Ability to perform technical analysis using software such as JMP, efficiency in Microsoft office, project management (plus), communication.
* Experience in Lean Manufacturing & Root Cause Analysis
* Previous experience in process engineering, upstream and/or downstream technical support or manufacturing operations for biologics and/or vaccine products.
* Experience with operationalization of GMP operations and/or large facility builds or renovations as well as ability to work in a fast-paced environment.
* Proven self-motivation, ability to drive improvements, and inspire others.
* Demonstrated ability to work effectively as part of diverse teams.
* Strong problem-solving skills and the ability to overcome technical and organizational challenges.
* Excellent attention to detail, highly independent with initiative.
* Excellent troubleshooting and problem-solving skills.
* Ability to challenge the status quo with a continuous improvement mindset.
* Strong leadership ability and collaborative skills.
* Strong analytical and presentation skills.
* Ability to lift 25 lbs, if required.
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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