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Senior Director, Technical Services

Alexion Pharmaceuticals, Inc.

Dublin, County Dublin, Ireland دوام كامل

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خبرة
أي
مرتب
الوظائف الشاغرة
1
تم النشر
• 6 نجوم
وضع العمل
في المكتب
تعليم
Bachelors degree
سيرة ذاتية
مطلوب للتقديم

مكان عملك

المسمى الوظيفي

About the Role

The Senior Director, Technical Services will lead and develop high-performing teams within bulk drug substance, finished product packaging, and device assembly operations at the Dublin site. This role focuses on providing technical oversight to assure robust, reliable, and efficient manufacturing processes while spearheading the integration of innovative products and technologies. The position is also responsible for overseeing the site’s Contamination Control Strategy at a senior leadership level to embed best practices and continuous enhancements. Additionally, the role champions adoption of AI, data analytics, and advanced manufacturing technologies to deepen process understanding, improve quality, boost yields, and reduce costs, thereby ensuring the consistent supply of cutting-edge biologics and combination products to patients affected by rare diseases.

Key Responsibilities

  • Provide both strategic vision and hands-on leadership to Technical Services teams supporting mammalian cell culture, downstream processing for BDS manufacturing, finished product packaging, and device assembly operations, ensuring consistent process outcomes and regulatory compliance.
  • Lead the introduction of new products and technology transfers to the site, managing process and cleaning validations, introduction of materials, and preparation of regulatory documentation for approvals.
  • Manage receiving-site design transfers for new vial packaging and combination product assembly, ensuring effective project governance, milestone tracking, and cross-functional teamwork.
  • Collaborate closely with Process Development, Engineering, and Automation to design and execute robust process control strategies, incorporating risk assessments, control plans, and documentation supporting equipment and automation qualifications.
  • Own and continuously enhance the site Contamination Control Strategy at a senior leadership level by performing risk assessments, monitoring processes, and implementing targeted improvements.
  • Engage a wide network of experts and stakeholders to identify, adapt, and implement best contamination prevention practices aligned with industry, regulatory, and network standards across all manufacturing sectors.
  • Lead deployment and integration of AI, data analytics, and digital tools within Technical Services to enhance monitoring of process performance, facilitate early detection of deviations, and drive yield optimization based on data insights.
  • Take charge of investigations into significant deviations and process issues, ensuring timely root cause analysis, implementation of corrective and preventive actions (CAPA), and long-term risk reduction.
  • Identify and execute process optimization projects aimed at improving process robustness, increasing yields, and decreasing cost of goods by leveraging deep process expertise and advanced analytics.
  • Provide technical leadership during regulatory audits and inspections acting as a subject matter expert in technology transfer, process validation, control strategies, and ongoing process verification activities.
  • Oversee preparation, review, and approval of Chemistry, Manufacturing, and Controls (CMC) material for regulatory filings, ensuring clarity, scientific accuracy, and alignment with global requirements.
  • Recruit, retain, and cultivate exceptional technical and scientific talent, fostering a strong leadership pipeline and sustaining high levels of expertise within the Technical Services function.
  • Promote a work culture centered on safety, quality, integrity, and continuous improvement consistent with the mission to serve patients with rare diseases.

Essential Qualifications and Experience

  • Bachelor’s degree in Science or Engineering or a related discipline.
  • Extensive technical and operational experience in biopharmaceutical manufacturing processes.
  • Advanced digital literacy with proven track record in implementing AI and data analytics solutions.
  • Demonstrated success in leading technology transfer and process support in commercial manufacturing environments.
  • Strong leadership capabilities with experience organizing and managing technical teams toward corporate objectives.
  • Excellent interpersonal skills enabling effective collaboration within matrix organizations.
  • Proven skills in clearly presenting and defending scientific and technical approaches both verbally and in writing, including during regulatory inspections.

Preferred Qualifications

  • Master’s degree or postgraduate qualification in science, engineering, or business.
  • Experience leading technical teams across multiple technology platforms or modalities.

Additional Information

Join a pioneering biopharmaceutical environment that combines the expansive resources of a leading global company with the innovative spirit of a biotech enterprise. Work in an inclusive culture that values integrity, curiosity, and meaningful impact, with ample opportunities for career advancement while contributing to transformative treatments for rare diseases.

Applications from all qualified applicants are encouraged, with a commitment to creating an equitable and inclusive recruitment process. Reasonable accommodations can be provided upon request to support applicant needs.

Important Dates

  • Role posted: 10-Jul-2026
  • Application closing: 19-Jul-2026

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