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Associate Director, External Manufacturing and Supply Operations - Job Opportunity at Cytokinetics

Dublin, Ireland
Full-time
Senior
Posted: August 19, 2025
On-site
EUR 120,000 - EUR 160,000 annually, reflecting the senior-level responsibilities, specialized biopharmaceutical expertise, and Dublin market premiums for experienced supply chain professionals in the life sciences sector

Benefits

Opportunity to work on first-in-class and next-in-class muscle activators and inhibitors, providing exposure to cutting-edge cardiovascular therapeutics development
International travel opportunities up to 25% for global manufacturing oversight and relationship building
Cross-functional collaboration with Supply Chain, Quality Assurance, Regulatory Affairs, and Finance teams for comprehensive skill development
Direct involvement in commercial and clinical supply operations for late-stage biopharmaceutical products
Exposure to global regulatory frameworks including CFR, EU GMP, and ICH guidelines enhancing regulatory expertise
Leadership role in CMO selection and onboarding processes, providing strategic decision-making experience

Key Responsibilities

Drive strategic partnerships with contract manufacturing organizations globally, directly impacting drug supply reliability for cardiovascular patients
Execute mission-critical manufacturing and supply plans that ensure uninterrupted clinical trial progression and commercial product availability
Lead technical operations including BOM development, specifications management, and change control processes that maintain product quality and regulatory compliance
Orchestrate complex logistics and import/export activities across international markets, ensuring global supply chain efficiency
Serve as the authoritative manufacturing representative for critical documentation approval, directly influencing product release decisions
Champion product qualification initiatives including validation protocol oversight, ensuring manufacturing readiness for commercial launch
Spearhead CMO selection and technical transfer processes, establishing new manufacturing capabilities that support company growth
Manage inventory optimization and financial reconciliation processes that directly impact operational cash flow and supply reliability
Lead cross-functional risk management initiatives with continuous improvement focus, preventing supply disruptions
Drive regulatory submission support and CMC activities that enable successful product approvals

Requirements

Education

BS/BA Degree in Life Science, Biology, or Engineering discipline from an accredited college or university, or equivalent desired

Experience

10+ years combined experience in manufacturing, outsourced operations, technical operations and/or supply chain in regulated healthcare industry, preferably within biotech/pharmaceutical industry

Required Skills

cGMP career experience embedded in a pharmaceutical manufacturing plant is essential – with first-hand knowledge of plant operations, with the insight to assess performance, and diagnose issues directly at the source Technical background with knowledge of engineering and pharmaceutical manufacturing processes in small molecule is required, and experience in DS/API production is desirable Excellent problem-solving skills, with the ability to address complex challenges under time pressure Demonstrated expertise in risk management, with a history of successfully implementing risk mitigation strategies The ability to function in a fast-paced, high-growth, entrepreneurial environment Ability to travel domestically and internationally ~25% Strong working knowledge and understanding of both regional and international regulations by government agencies affecting the pharmaceutical industry (CFR's, EU GMP, ICH) Timely and effective communication across multiple audiences, both verbally and in writing Familiarity with ERP/MRP systems Proven risk management acumen with a continuous improvement mindset
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Sauge AI Market Intelligence

Industry Trends

The cardiovascular therapeutics market is experiencing unprecedented growth driven by aging populations and increasing prevalence of heart failure, with novel muscle activators representing a particularly promising therapeutic class that could revolutionize treatment paradigms. Companies developing first-in-class cardiac muscle activators are positioning themselves at the forefront of a potential multi-billion dollar market transformation, making supply chain excellence critical for commercial success. Biopharmaceutical companies are increasingly relying on external manufacturing partnerships to optimize capital efficiency and accelerate time-to-market, with contract manufacturing organization (CMO) management becoming a core competency that directly impacts competitive advantage. The trend toward specialized CMO relationships requires sophisticated technical oversight and relationship management skills that combine regulatory expertise with operational excellence. Regulatory harmonization across global markets is driving demand for professionals with multi-regional compliance expertise, particularly those familiar with FDA, EMA, and ICH guidelines for cardiovascular therapeutics. The complexity of managing global supply chains for late-stage biopharmaceutical products requires deep understanding of international regulatory frameworks and cross-border logistics optimization.

Role Significance

Likely collaborates with cross-functional teams of 15-25 professionals across Supply Chain, Quality Assurance, Regulatory Affairs, and Finance, while managing relationships with multiple external CMO partners and their technical teams
Senior individual contributor role with significant strategic impact, reporting to Director level while managing critical external partnerships that directly influence product availability and commercial success. The position combines technical expertise with business acumen, requiring independent decision-making authority over manufacturing operations that affect patient access to life-saving therapeutics.

Key Projects

Lead technical transfer projects for new manufacturing sites, ensuring seamless transition of production capabilities while maintaining product quality and regulatory compliance Drive CMO selection and qualification initiatives that establish new manufacturing partnerships, directly impacting the company's ability to scale commercial production Oversee critical supply chain optimization projects that ensure uninterrupted clinical trial material supply and commercial product availability across global markets

Success Factors

Deep technical manufacturing expertise combined with strong business acumen enables effective CMO partnership management and strategic decision-making that balances quality, cost, and timeline objectives. Success requires the ability to translate complex technical requirements into actionable manufacturing plans while maintaining rigorous cGMP compliance standards. Exceptional relationship management skills with both internal stakeholders and external CMO partners, demonstrating the ability to influence without direct authority while building trust through technical competence and reliable execution. The role demands diplomatic skills to navigate competing priorities while maintaining focus on patient impact. Proven ability to operate effectively in ambiguous, fast-paced environments while maintaining attention to detail and regulatory compliance, particularly important for a late-stage biopharmaceutical company approaching commercial launch where supply chain reliability is critical for patient access and business success.

Market Demand

High demand driven by the expanding biopharmaceutical sector in Ireland and the critical shortage of professionals with both cGMP manufacturing experience and external supply chain management expertise

Important Skills

Critical Skills

cGMP manufacturing plant experience is absolutely essential as it provides the foundational knowledge needed to effectively assess CMO performance, diagnose manufacturing issues, and ensure product quality standards are maintained across external partners. This hands-on manufacturing background enables credible technical discussions with CMO teams and informed decision-making about manufacturing capabilities and risk mitigation strategies. Risk management expertise with proven implementation experience is critical given the high-stakes nature of pharmaceutical manufacturing where supply disruptions can directly impact patient access to life-saving therapeutics. The ability to identify, assess, and mitigate manufacturing and supply chain risks is essential for maintaining business continuity and regulatory compliance. Strong communication skills across multiple audiences are vital for success in this cross-functional role that requires effective collaboration with internal teams while managing complex external CMO relationships, regulatory submissions, and technical transfer activities that demand clear, precise communication of complex technical concepts.

Beneficial Skills

Advanced project management certifications (PMP, Six Sigma) would enhance the ability to drive complex technical transfer and manufacturing optimization projects while maintaining strict timelines and quality standards International regulatory affairs expertise beyond the core requirements would provide additional value in navigating complex global regulatory landscapes and supporting market expansion initiatives Financial analysis and budgeting skills would complement the operational expertise and enable more strategic contribution to manufacturing cost optimization and CMO partnership negotiations

Unique Aspects

Opportunity to work with first-in-class muscle activators representing potentially breakthrough cardiovascular therapeutics that could transform treatment paradigms for heart failure patients
Direct involvement in both clinical and commercial supply operations for a late-stage biopharmaceutical company, providing exposure to the critical transition from development to commercial manufacturing
Strategic role in establishing and managing CMO relationships that will be foundational for the company's commercial success and ability to serve patients globally
Combination of technical manufacturing expertise with international supply chain management in the specialized cardiovascular therapeutics market

Career Growth

3-5 years to Director level with demonstrated success in external manufacturing management and strategic partnership development, 7-10 years to VP level with proven track record of supply chain optimization and commercial launch support

Potential Next Roles

Director of External Supply Operations with expanded scope including strategic CMO partnership development and global supply chain optimization VP of Manufacturing and Supply Chain with full P&L responsibility for external manufacturing operations and strategic supplier relationships Chief Operating Officer role focusing on operational excellence across manufacturing, supply chain, and commercial operations in mid-sized biopharmaceutical companies

Company Overview

Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company specializing in cardiovascular therapeutics with a focus on first-in-class muscle activators and next-in-class muscle inhibitors. The company has established itself as a leader in muscle biology and cardiac muscle performance, with a pipeline of small molecule drug candidates specifically engineered to impact myocardial function and contractility.

Well-positioned specialty biopharmaceutical company with differentiated technology platform and late-stage clinical assets in the high-value cardiovascular therapeutics market, likely preparing for commercial launch activities given the focus on both clinical and commercial supply operations
The Dublin location suggests this role supports European operations and manufacturing partnerships, likely serving as a regional hub for EU regulatory compliance and supply chain management with responsibility for import/export activities across European markets
Mission-driven organization emphasizing patient impact, collaborative cross-functional teamwork, and scientific rigor, with an entrepreneurial environment that values tenacity, compassion, and innovation in advancing cardiovascular therapeutics
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