Associate Director, Spray Drying New Product Commercialisation Lead (Tipperary, Ballydine)

Merck; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company seeks an Associate Director Spray Drying New Product Commercialisation Lead to manage technical capabilities for spray drying processes. You will ensure compliance with GMP and GLP, support development and commercial production, and lead a team. The role demands extensive pharmaceutical experience and skills in project management and engineering principles.

Qualifications

• 10+ years of relevant pharmaceutical industry experience focused on enabled formulations & spray drying.
• Proven expertise in designing and executing DoEs for spray drying process development and scale-up.
• Deep understanding of the engineering principles involved in spray drying.

Responsibilities

• Lead spray drying technical capability for formulation processes.
• Provide technical support for commercial scale spray dryer operations.
• Collaborate with Engineering, EHS, and Procurement for equipment installation.

Skills

Communication and interpersonal skills

Strategic thinking and problem-solving

Clear understanding of financial management

Project management

Time management

Working collaboratively

Ethics and Integrity

Education

BSc/BEng or higher in Chemistry, Manufacturing, Engineering, or a Science discipline

Job description

Job Description

We have an exciting career opportunity for an Associate Director Spray Drying New Product Commercialisation Lead to be based on our Tipperary, Ballydine site.

Role overview:

You will lead the spray drying technical capability for the formulation processes at our Ballydine site. This is a hands-on spray drying role in the pharmaceutical industry. It would be essential for you to utilise your extensive, demonstrable experience in commercial-scale spray drying process development, technology transfer, and support of a running commercial spray dryer. You will lead the team that provides ongoing technical support for commercial scale spray dryer operations and co-lead Design of Experiments (DoE) for new SDI process development. Your participation will be ‘key’ in the capital project for the installation and qualification of a new spray-drying facility.

What you will do:

• Process Development: You will direct the technical support for spray drying process development at commercial scale, including formulation process DoE design, execution strategy, and data-driven optimization.
• Technical Support: You will provide direct technical support to development, clinical, and commercial supply production for our spray dried processes, which involves evaluations of raw materials and the optimization of SDI processes. This extends to participation in campaign preparation and follow-ups, safety and environment reviews, batch sheet reviews, and more.
• Technical Expertise: You will stay up to date with the latest developments in spray drying processes, both within our organization and externally. You are expected to use this knowledge to coach your colleagues and help achieve our overall divisional goals.
• Engineering Support: You will participate in the capital projects for the installation, qualification, and start-up of spray-drying equipment; collaborate with Engineering, EHS, and Procurement to ensure on-time, compliant implementation.
• Resource Management: You will provide the technical resources needed to support the IPT in achieving profit plan targets by meeting operational targets, managing the impact of changes, and ensuring a timely and compliant closure of process deviations and other process-related incidents.
• Safety and Compliance: You are responsible for ensuring that all work is conducted safely and in compliance with current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
• Team Development: You'll also be expected to develop your team by delegating tasks, providing feedback, and offering opportunities for professional growth.
• Administrative Duties: As part of the administrative role, you will handle the compilation of various reports, budgetary considerations, and other administrative tasks necessary for the running of the department.
• Managerial responsibilities: You will contribute to employee recruitment, development, and assessment programs, and directly input into the implementation of the site human resources plan and organizational development.
• cGMP Compliance: You will be accountable for ensuring assigned processes/systems managed are carried out in conformance with site divisional and corporate quality standards, and that all deviations from standards are thoroughly investigated and corrected. This includes being the Sub-System Owner for various Quality Management System sub-systems.

What you will need to be considered for the role:

• BSc/BEng or higher in Chemistry, Manufacturing, Engineering, or a Science discipline.
• A minimum of 10 years of relevant pharmaceutical industry experience, with a significant portion of that time focused on enabled formulations & spray drying.
• Proven expertise in designing and executing DoEs for spray drying process development and scale-up.
• Deep understanding of the engineering principles involved in spray drying.
• Familiarity with process, equipment, and cleaning validation, as well as cGMP's and regulatory requirements, is required.
• Thorough understanding of production operations, MBR Batch System and Recipes, Deviation Management, Change Control, and Procurement Systems.

Skills/Competencies:

• Communication and interpersonal skills
• Strategic thinking and problem-solving
• Clear understanding of financial management
• Project management and time management
• Working collaboratively
• Ethics and Integrity

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.