Director, Operations - Drug Product (Biologics)

Merck • Wilmington, DE

21h • $173,200 - $272,600 • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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.

Responsibilities

• 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.
• 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).
• Work collaboratively with cross-functional teams to streamline technology transfers and commercial approvals, meanwhile nurturing and empowering your operations team.
• Foster a culture of continuous learning and improvement, leading or supporting various site functional and cross-functional structures for departmental alignment.
• Champion operational and technical excellence for efficient production and implement Lean principles for process optimization.
• Manage relevant quality topics, and ensure permanent inspection readiness, upholding our Manufacturing Division Quality Management System (QMS) requirements.
• Oversee financial forecasts and workload for departmental cost improvements, aligning with capital and expense targets while contributing to sustainability and cost reduction initiatives.
• Leverage digital tools for operational efficiency and informed decision-making, keeping pace with emerging digital technologies relevant to manufacturing processes.
• Achieve 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Director