Director, Operations - Drug Product (Biologics)

BioSpace; Wilmington (DE); On-site; USD 180,000 - 280,000; Full time

Job summary

BioSpace in Wilmington seeks a Director, Operations for Drug Product to lead manufacturing of high-potent biologics in a new hi-potent facility. You will drive site readiness, implement Lean processes, and ensure cGMP compliance across commercial and clinical programs.

You will mentor cross-functional teams, manage capital and expenses, and partner with QA, regulatory, and supply chain to deliver reliable supply.

Qualifications

• Degree in Engineering or Science with 12+ years experience, or an advanced degree with relevant leadership roles.
• Proven biotech/vaccines/pharma manufacturing site experience, especially drug product sterile manufacturing.
• Experience leading cross-functional teams in start-up or scale-up environments.

Responsibilities

• Lead drug product manufacturing for commercial and new products at a hi-potent facility.
• Shape site and organizational strategies as a Site Leadership Team member.
• Implement Lean processes to optimize production and ensure QMS compliance.
• Oversee financial forecasts, capital and expense targets, and KPI performance.

Skills

Leadership

GMP knowledge

Lean manufacturing

Cross-functional teamwork

Education

Bachelor’s degree in Engineering/Science

Master’s degree in a related field

PhD in a relevant field

Tools

cGMP systems

QMS experience

Job description

Director Operations for Drug ProductDo 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

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 years6 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 productPreferred 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.