Associate Director, Product Team Lead - Technical Development and Services

T-pro; Cork; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

A leading global biotechnology company is seeking an Associate Director, Product Team Lead for technical development and services. Responsibilities include overseeing Drug Substance lifecycle management, providing technical expertise, and driving process standardization. Candidates should have over 10 years in the pharmaceutical industry and a Bachelor’s degree in a relevant field. This hybrid role is located in Cork, Ireland, offering opportunities for impactful work in a dynamic environment.

Qualifications

• 10+ years of professional experience in the pharmaceutical industry, including managerial experience.
• Strong working knowledge of statistics, quality systems, and regulatory requirements.
• Experience collaborating effectively with other functional groups to achieve business objectives.

Responsibilities

• Drive process and manufacturing technology activities across the product family network.
• Support submission and implementation strategies with relevant stakeholders.
• Perform technical feasibility assessments for product transfers.

Skills

Biopharma Sterile Manufacturing

Project Management

Statistics

Exceptional Communication

Risk Assessment

Education

Bachelor's degree in Sciences

Master of Science or related PhD

Job description

Associate Director, Product Team Lead - Technical Development and Services

Overview

Responsible for Drug Substance technical leadership and oversight of all commercial lifecycle management activities.

About BioMarin

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Location

Shanbally Ringaskiddy, Cork (Hybrid)

Closing Date

Closing Date: Friday 6 June 2025

Summary Description

Responsible for Drug Substance technical leadership and oversight of all commercial lifecycle management activities.

Responsibilities

• Drug Substance technical leadership and oversight of the product family to ensure visibility, integration and coordination of all technical lifecycle activities.
• Provide technical and practical expertise and support across modalities for the involved platform focused on new product development and manufacturing processes.
• Drive process and manufacturing technology activities across the platform product family network, working closely with the manufacturing sites (internal / external) to improve capability and add value.
• Drive standardisation activities across the platform product network.
• Support Process Stewards and Commercial Support by standardising and optimising related technical processes across the network.
• Support submission and implementation strategies with relevant stakeholders (e.g., regulatory approvals, planning).
• Management and scientific support of product transfers from and manufacturing sites (internal / external).
• Perform technical feasibility assessments for product transfers in close collaboration with relevant stakeholders. Identify potential risks and create contingency plans as needed.

Scope / Key Performance Metrics

• Lifecycle management activities delivered on time and budget.
• Successful Health Authority Approvals where applicable.

Education

Bachelor's degree in Sciences (preferably Biochemical Engineering or Biological Sciences). Master of Science or related PhD degree preferred.

Experience

• Experience in Biopharma Sterile Manufacturing strongly preferred.
• 10+ years of professional experience in the pharmaceutical industry, including managerial experience. Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology).
• Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of Biologics.
• Advanced project management experience/skills including method transfers, and risk assessment.
• Knowledge of OPEX principles and tools, and knowledge of R&D processes.
• Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network.
• Experience collaborating effectively with other functional groups to achieve business objectives.

EEO Statement

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.