Director, Operations - Drug Product (Biologics)

About the role

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.

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.

Qualification And Experience

Required Experience and Skills

• 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.

#ADC #ADC2026

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}

Preferred Skills

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• Current Contingent Workers apply HERE

US and Puerto Rico Residents Only

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Pay and benefits

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.

The application deadline for this position is stated on this posting.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

• Employee Status: Regular
• Relocation: Domestic
• VISA Sponsorship: Yes

Travel Requirements

• 10%
• Flexible Work Arrangements: Not Applicable
• Shift: Not Indicated
• Valid Driving License: No
• Hazardous Material(s): n/a
• Job Posting End Date: 10/31/2026

Additional information

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.