Director, Engineering - Technical Operations

Job description

Job Description 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. undefined undefined Execute and improve the validation program for processes to ensure compliance with cGMP requirements and our Company's corporate quality policies and standards. Responsible for the identification and implementation of scientific and technological improvement opportunities including both incremental industry advancements as well as transformational innovations. Deliver major cost and quality improvements for the IPT aligned to the Operating Business Unit Strategic Roadmap, including the development of business cases, strategies, plans, timelines, and budgets for execution. Ensures timely leadership and/or support of technical CAPA, including thorough investigations, root cause analysis and identification, and corrective and preventive actions to address root cause including developing/execution of change management and Kaizen efforts. Provide direct technical support to the IPT for multiple processes and technologies. This support involves evaluation of raw materials including new suppliers, development of process fits, participation in campaign preparation and follow-ups. It also involves safety and HAZOP reviews, process monitoring, atypical investigations and resolutions including trending and prevention, defining cleaning processes for new production processes and review of the cleaning procedures/documentation. ​ Education/Qualifications and Experience A degree or equivalent in Engineering, Science, Technical, or other relevant fields: Bachelor’s degree + 12 years industry experience Or Masters + 10 years Or PhD + 8 years 6 or more years demonstrated leadership ability and experience managing, coaching, and mentoring high-performing cross function teams. Strong background in manufacturing/and providing technical oversight for biologic products including potent drug substances (DS) and drug product (DP) products, including Antibody Drug Conjugates (ADCs) following GMP standards. Experienced in new facility operational readiness, facility, equipment and process design, and operation ramp up including organization, people and operation management system Experienced in New Product Introduction, Technical Product Transfer, manufacturing process and investigation / change management Experience in regulatory inspection preparedness planning for regulatory agency visits and inspections while understanding and implementing processes, controls, and methods that align with global health authority regulatory expectations. Preparation, review, and response preparation of global regulatory submissions i.e. BLAs and NDAs and other technical communications. Business:Excellent verbal and written communication, presentation and interpersonal skills Progressive people management skills Negotiation skills Demonstrable analytical and systematic problem-solving skills Strong influencing skills Business acumen Proven financial management skills Risk management skills Strategy development Ability to effectively manage complex projects across multiple discipline Leadership:Focus on Customers and Patients Collaborate Act with Candor and Courage Make Rapid, Disciplined Decisions Drive Results Build Talent Demonstrate Ethics and Integrity Preferred Experience and Skills:Operations experience in the manufacturing of potent drug substance and/or sterile drug products, at pilot and/or commercial scale. Experience with commercialization of ADC programs through PPQ and launch Working knowledge in analytical methods and product at