Analytical Development Manager
| Reference: | SBHQ00000306 |
Location: |
Dublin
|
| Qualification: | Doctorate | Experience: | 3-4 Years |
| Job Type: | Permanent | Salary: |
Not Disclosed |
Our client's vision is to significantly improve patient health and quality of life by providing effective therapeutic solutions for unmet medical needs.
Their Mission is to be a Global speciality Health Care Group
Their Objective is to have a world presence and to become a leader in their targeted therapeutic areas.
Our Client is now recruiting for the following position;
Analytical Development Manager
Reporting to the Director of API Development, the Analytical Development Manager will be responsible for the delivery of a coordinated analytical development program for all small molecule and peptide active ingredients within the group's development portfolio.
Main Responsibilities:
- Co-ordinate the API analytical development organisation to ensure that robust, reliable test methods, specifications and regulatory documents are delivered for all APIs during the various phases of clinical development and to ensure effective transfer to routine manufacture in-house or at sub-contractors;
- Ensure prompt and coordinated testing and release of raw materials, intermediates, reference standards and API, for all API process development activities and manufacturing campaigns;
- Lead and develop the API analytical development organisation to ensure appropriate staff, facilities and working practices are in place and maintained to meet regulatory, GMP and EHS requirements.
- Manage API stability programs and provision of reference materials.
Candidate Profile:
- The preferred candidate will haveA PhD in Chemistry, Chemical Engineering, Analytical Sciences or other relevant qualification, with relevant pharmaceutical drug development experience, including experience within API analytical development in a senior role.
- Experience in developing analytical methods for peptides, biologics or similar complex APIs would be an advantage.
- Significant experience in managing technical functions and working within cross-functional teams within pharmaceutical research and development.
- Proven ability to transfer methods into commercial API facilities.
- Proven ability to lead a team and earn respect/influence senior colleagues in a cross-functional, global environment.
If you would like further information you can contact: Stephen Boylan | Tel: +353 (0) 1 507 9255