Associate Director of API Process Manufacturing
Our client is a major multinational pharmaceutical manufacturer based in Dublin now have a permanent role for an Associate Director of API Process Manufacturing within their virtual organisation.
Scope of Associate Director of API Process Manufacturing:
This hire will lead the Process Manufacturing A&I team, providing technical leadership on manufacturing processes relating to the manufacture of small molecule API and corresponding intermediate materials within Process Manufacturing group and to CMOs.
This is a new role with the aim of strengthening of their senior management team due to continued growth and expansion.
Responsibilities of Associate Director of API Process Manufacturing:
Act as a recognized subject matter expert in GMP API Process Manufacturing
Act as a mentor or consultant within the group and for GMS and R&D, when required.
Act as the Technical Lead and/or project lead for tech transfer projects.
Provide leadership support and technical consultation to the Director.
Accountable for leading significant projects in technology transfer and process robustness improvement.
Create policies, directives and procedures to ensure maintenance of technical best practice and regulatory compliance.
Support operational management of CMO within Virtual Plant Teams
Provide ongoing technical support to CMO to ensure compliance and security of supply ? metrics review, investigation close-out, change control review, APQR review, process improvement. Implement / OPEX initiatives as necessary.
In-depth knowledge of global regulatory requirements related to design and control of pharmaceutical manufacturing processes.
Lead Process Manufacturing A&I team.
Requirements for Associate Director of API Process Manufacturing:
A PhD in Chemistry is required for this role in addition to a minimum of 10 years? experience in a leadership role in an API process manufacturing or product development environment.
Subject Matter Expert level knowledge of API process manufacturing.
Experience people manager, managing a team of Technical Managers / Process Specialists.
Proven record of achievement in technical and project leadership.
Ability to interact at all levels of the organisation with proven influencing and negotiation ability.
Excellent interpersonal skills, possess the ability to work well both on own initiative and also within a team.
Superb communication and presentation skills.
Please phone Larry on +353 1-2302400 / firstname.lastname@example.org