Director, Operations - Drug Product (Biologics)

Job Description

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.

Required Skills:

Preferred Skills:

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Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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. Asa 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:

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The salary range for this role is

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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