Job Description
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 role will provide technical leadership on manufacturing processes relating to the manufacture of small molecule API and corresponding intermediate materials within Process Manufacturing group and to Contract Manufacturing Organisations.
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.
- Ensures a high level of current technical knowledge is maintained within the Manufacturing Technology group.
- Provide leadership support and technical consultation to Manufacturing Technology 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:
Masters in Organic Chemistry. Ideally a PhD in Chemistry.
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 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie