Provides leadership, strategies, and direction for the end-to-end value-added operation. Drives quality, supply, and financial performance of the Operations. Drive performance of operations team.
Essential Functions and Responsibilities
Works with quality organization to set the standard for a quality mindset within the operations organization. Ensures accountability to the quality culture fostered at the site
Ensure all processes and procedures related to operations are in full accordance with GMP, CFR, site quality systems, company policies and promote a culture of quality, compliance, and excellence
Support regulatory strategy and activities, including participating in client, regulatory, and internal inspections/audits,
Works collaboratively with Regulatory CMC (Chemistry, Manufacturing, and Controls), Quality Assurance, Process Development, Global MSAT, Project Management, Business Development, Supply Chain, Engineering, and Facilities to ensure the site and corporate goals are met.
Ensures operations area is kept in a cGMP state of repair through coordination of preventive maintenance and cleaning activities with the Facilities department.
Drive the Business:
Responsible for developing and adhering to Operations resource models, input into the development of new/ existing client proposals, Manufacturing Service Agreement (MSA) and Scope of Work (SOW). Execute agreements ensuring both client expectations are met and agreed upon for the profitability and success of the project.
Accountable for the tracking, trending, and improvement of the Operations KPIs, driven by cost-effective and efficient output of client’s products.
Provide strategic direction and objectives setting to meet financial and operational Operations requirements that are aligned with Site and Regional targets.
Work directly with internal and external stakeholders on projects of existing and new clients to ensure appropriate capacity, improve quality, adequate sourcing of critical components.
Work directly with MSAT, Development, and Manufacturing Support groups to ensure smooth tech transfer of new products.
Drive operational excellence mindset, capability, and execution plan.
Required to build commercial readiness activities.
Set expectations for operation excellence and right first time execution
Drive education and execution of company mission and vision within the Operations.
Lead by example and emulate the company’s core leadership values
Drive Operations and High Performance Team culture within the Operations Leadership team.
This role drives individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry.
Ensure staff has the proper training, skill set, and personal development opportunities to assure their ability to carry out assigned tasks in compliance with HCC procedures and policy as well as local, federal and global regulations and industry standards.
Lead a learning environment whereby team members are enabled to increase their skills and contributions to the Operations KPI’s.
Collaborate within the organization to manage the interface between cross-functional teams to align the functional strategy with the program and corporate goals
Provide direction and leadership for change management initiatives.
Bachelor’s degree or higher in relevant life science or engineering discipline
Minimum of 8 years combined industry/academic experience in cell processing, cell culture, cell analytics, and related GMP technologies, preferably for the manufacture of cell therapy products
Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.
Comprehensive knowledge in Software Validation and Data Integrity Principles.
Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations.
Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.
Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.
Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)
Knowledge of Software Risk Management Principles and tools.
Knowledge and proven ability working with Risk Management methodologies and tools.
Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus.
Experience with application system validation and infrastructure qualification.
Demonstrated excellence in technical writing in the preparation of protocols and reports, presentations and/or other communications
Understanding of the technical principles, theories, and concepts of low complexity technology transfer and the manufacturing of cell therapy or similar products
Ability to provide technical solutions to a variety of technical problems of low complexity scope and the ability to suggest improvements and adaptations to methodologies, processes, products
Strong emotional intelligence: self-awareness, self-control, empathy, and influence
Ability to effectively interface with peer groups in the site and work collaboratively to achieve site goals
Collaborates with other team members and demonstrates outstanding interpersonal skills
Ability to work semi-autonomously in an entrepreneurial and fast-paced environment
Strong business acumen to handle internal and external stakeholders
Ability to think strategically and act tactically (detail-oriented)
Analytical and problem-solving skills with innovation and continuous improvement seeking mindset
Strong communicator, listener, and influencer
Must have the ability to work in a team-oriented environment and with clients
Must be able to work during the weekend, holidays and as required by the company
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
Must be able to handle the standard/moderate noise of the manufacturing facility
Must be capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms, and talk or hear
The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance)
Lead Manufacturing Associates