Director, Engineering - Technical Operations

Technical Operations Director

The Technical Operations Director is accountable for the operation of the Technical Operations Department. The role will serve on the Site Leadership Team (SLT) and will be responsible for developing the strategic manufacturing/technical roadmap for the facility. As member of the SLT, the incumbent will play a key role in the development of policy and co-ordination of overall site operations. The role plays a critical part in strategic project realization of the Wilmington Biotech facility, a new hi-potent facility in our Company's Biologic manufacturing network, ensuring that site's mission and objectives are effectively achieved, consistent with our Company's requirements to ensure compliance, safety and reliable supply to our customers.

The Technical Operations Director is accountable for planning and on-time execution of commercialization activities of our pipeline products and routine clinical/commercial operations. This role will report into the Executive Director, Biologics Technical Organization, and will have the following functions reporting into the role: (1) Process Engineering (2) Site and Process Validation (3) Technical Operations support and (4) Technical Transfer activities.

Principle Roles & Responsibilities / Accountabilities

• Lead the site Technical Operations team. Identify, recruit and manage the Technical Operations Team at the site, implementing a strong quality culture and ensuring employee engagement and development in line with the site's talent framework.
• Strong department management including resource management, talent development, and day to day management of employees
• Ensure that the team receives appropriate resources to develop technical and leadership skills, drive a high performing and inclusive culture, and --stimulate personal growth and development in line with role.
• Actively manage performance and develop team members to achieve organizational goals and employee personal and professional growth. Build a strong pipeline of talent and robust succession plans for key positions.
• Develop annual operations financial plans, provide quarterly guidance on adherence, and manage all department operations within the targets established.

Technical Leadership

• Manage technical teams to support new product commercialization, technology transfer, manufacturing, filing, and licensing of potent drug substances (DS) and drug product (DP) products, including Antibody Drug Conjugates (ADCs). Includes the sustained manufacturing and validated state of all products, processes, equipment, and technologies post-transfer.
• Work with CPTL and key business partners to ensure the facility's organizational design and operating model principles are aligned with our Company's organizational needs and platform processes to support future pipeline products.
• Accountable for providing key input into all phases of facility startup-from facility, process, equipment, logistics and utility design to establishing systems and programs for routine manufacturing of cytotoxic and non-cytotoxic compounds, ensuring compliance through validation, operational readiness, and licensing/ launch of new products.
• Responsible for implementing departmental operating policies, procedures and budget so that the technical operations team operates effectively to ensure right first-time execution and delivery of high-quality products manufactured at the facility.
• Develop team organization structure, recruit, and on-board employees to build a competitive team that meets the project and production ramp up plan.
• Actively partner with Operations, Quality, Supply Chain, Global S&T teams, R&D, GES, and Regulatory Affairs on new product introduction (NPI) to ensure that product quality, availability, and compliance with manufacturing processes are maintained within budget and delivered on time, while also providing support for regulatory filings.
• Design and oversee process validation, qualification, and monitoring strategies, implementing master validation plans for processes, equipment, and facilities in collaboration with Subject Matter Experts and internal stakeholders.
• Work across the Biologics Technical Operations organization to benchmark performance, share/adopt best-practices, and leverage network expertise to ensure process robustness and agility in operations.
• Champion routine assessment of product performance/health, proactively identifying potential trends to enable intervention and mitigation well before supply interruptions.
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