Director, Operations

Director Operations for Drug Product Do you aspire to secure a critical role in the production of biologics-based medicines? Are you excited to lead dynamic teams in a state-of-the-art facility that brings transformative biotech treatments to patients globally? We invite you to become a part of our journey as the Director Operations for Drug Product. This role offers you the chance to contribute to the site's development and wield technical leadership to ensure successful GMP manufacturing. The Director, Operations – Drug Product 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. As a key member of the Site Leadership Team, you'll have the opportunity to shape site and organizational strategies, overseeing drug product manufacturing for commercial and new product introductions. Be part of facility start-up to manufacture high-potent products, eg antibody drug conjugates (ADCs) You will work collaboratively with cross-functional teams to streamline technology transfers and commercial approvals, meanwhile nurturing and empowering your operations team. You'll get to foster a culture of continuous learning and improvement, leading or supporting various site functional and cross-functional structures for departmental alignment. Tackling resource constraints and needs, you will champion operational and technical excellence for efficient production and implement Lean principles for process optimization. Upholding our Manufacturing Division Quality Management System (QMS) requirements, you will manage relevant quality topics, and ensure permanent inspection readiness. You will oversee financial forecasts and workload for departmental cost improvements, aligning with capital and expense targets while contributing to sustainability and cost reduction initiatives. You will have the chance to leverage digital tools for operational efficiency and informed decision-making, keeping pace with emerging digital technologies relevant to manufacturing processes. You will be accountable for achieving onsite Key Performance Indicators (KPIs), monitoring and striving to improve performance metrics related to hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, operational availability, and more. Principle Roles & Responsibilities / Accountabilities The Director, Operations – Drug Product 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. As a key member of the Site Leadership Team, you'll have the opportunity to shape site and organizational strategies, overseeing drug product manufacturing for commercial and new product introductions. Be part of facility start-up to manufacture high-potent products, eg antibody drug conjugates (ADCs) You will work collaboratively with cross-functional teams to streamline technology transfers and commercial approvals, meanwhile nurturing and empowering your operations team. You'll get to foster a culture of continuous learning and improvement, leading or supporting various site functional and cross-functional structures for departmental alignment. Tackling resource constraints and needs, you will champion operational and technical excellence for efficient production and implement Lean principles for process optimization. Upholding our Manufacturing Division Quality Management System (QMS) requirements, you will manage relevant quality topics, and ensure permanent inspection readiness. You will oversee financial forecasts and workload for departmental cost improvements, aligning with capital and expense targets while contributing to sustainability and cost reduction initiatives. You will have the chance to leverage digital tools for operational efficiency and informed decision-making, keeping pace with emerging digital technologies relevant to manufacturing processes. You will be accountable for achieving onsite Key Performance Indicators (KPIs), monitoring and striving to improve performance metrics related to hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, operational availability, and more. Requirement 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. Demonstrated experience in a biotech/vaccines/pharma manufacturing site, project, or other relevant roles, specifically drug product sterile manufacturing. Demonstrated experience in manufacturing clinical and commercial products. Understanding of cGMP requirements for commercial high-potent ADC manufacturing of drug product Preferred Experience And Skills Sterile manufacturing leadership & operations, with preferred multi-product experience. A leader who inspires, coaches, and fosters a high-performance organizational culture. A continuous learner who cultivates a culture of ongoing development within your team. An innovative thinker with excellent decision-making and problem-solving skills. Experienced in leading highly effective cross-functional teams with a passion for shaping the future of our organization. Capable of influencing and building relationships across organizational layers, as well as externally with partners. Required Skills Adaptability, Adaptability, Business Agility, Continuous Development, Cross-Functional Project Management, Customer Delivery, Data Analysis, Decision Making, Lean Manufacturing, Manufacturing, Manufacturing Quality Control, Manufacturing Technologies, Operations Management, Organizational Leadership, People Leadership, Performance Metrics, Process Improvements, Process Optimization, Product Compliance, Production Scheduling, Quality Compliance, Quality Control Management, Quality Control Systems, Quality Management, Regulatory Compliance {+ 7 more} US And Puerto Rico Residents Only Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. If you need an accommodation during the application or hiring process. Requirements As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $173,200.00 - $272,600.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance 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 Employee Status Regular Relocation Domestic VISA Sponsorship No Travel Requirements 10% Flexible Work Arrangements Not Applicable Shift Not Indicated Valid Driving License No Hazardous Material(s) n/a #J-18808-Ljbffr Merck