Project Manager - Biotechnology Manufacturing

About the Role

PE Global is seeking an experienced Project Manager for a leading multinational biotechnology client located in Dublin. This is a remote position initially offered on a 12-month contract basis. The role supports the Specialist Contract Development & Manufacturing team by overseeing New Product Introductions (NPI), providing technical assistance to manufacturing, and resolving complex production challenges to boost both efficiency and quality. Collaboration across departments ensures seamless manufacturing operations and compliance with regulatory standards. The role involves data insight and analysis, tactical task execution, and overall success of Amgen Contract & Development Manufacturing (ACDM) operations.

Key Responsibilities

• Lead and manage New Product Introductions and technology transfers to external manufacturing organizations, coordinating cross-functional teams while ensuring adherence to business processes.
• Plan projects, manage budgets, communicate progress, and produce reports while fostering continuous improvement initiatives to elevate quality and efficiency aligned with company goals.
• Monitor and follow up on department-wide projects from start to finish, managing timelines, risk identification, and escalation as necessary.
• Ensure accurate completion of budget, contractual, and confidentiality documentation related to manufacturing operations.
• Manage deviation investigations (major and minor) ensuring they comply with quality procedures and optimize corrective actions to prevent recurrence.
• Administer SICAR, CAPA, CAPA EV, and complex change control records.
• Track and report contract site performance metrics, identify enhancement opportunities, prepare meeting documentation, and participate actively in work centre team meetings.

Candidate Qualifications

• Bachelor’s degree in Business Administration, Engineering, or a related Science field.
• Over 5 years' experience in protein, API, DS, DP, or packaging manufacturing environments.
• More than 5 years working knowledge of cGMP, FDA regulations, validation principles.
• Minimum 2 years managing cross-functional or multi-location teams in project management roles.
• At least 1 year collaborating with external partners for clinical or commercial product launches.

Preferred Skills and Attributes

• Proven ability to manage matrix environments and influence stakeholders.
• Strong organizational and project management expertise across functions.
• Technical understanding of pharmaceutical manufacturing, commercialization, and compliance.
• Skilled negotiator with accountability and deadline-orientation amidst competing priorities.
• Expertise in operational excellence and continuous improvement practices.
• Familiarity with financial management and budgeting processes.
• Solid analytical, problem-solving, and decision-making capabilities.
• Knowledge of contract requirements and technical communication skills.
• Ability to lead and motivate teams effectively, showing initiative and independence.
• Proficient in Microsoft Office tools including Project, Excel, PowerPoint, Visio, and Smartsheet.

Additional Information

Work location: Remote, with client based in Greater Dublin
Contract duration: Initial 12 months
Visa requirements: Candidates must possess valid authorization to live and work in Ireland; no visa sponsorship is available.