This leading Pharmaceutical multinational innovator is a specialty biopharmaceutical company headquartered in the U.S with a Product Development/R&D Centre of Excellence based here in Dublin Ireland. This leader develops vaccines and antibody therapeutics for infectious diseases and opioid dependency in addition to providing medical devices for biodefense purposes. With just north of 2000 staff globally, this organisations revenue is seeing consistent growth year on year. This organisations mission is to protect and enhance life through the organisations specialty products and contract development and manufacturing services and are dedicated to providing solutions that address public health threats. Integral to this organisations success is the strenght of the organisations development pipeline which is supported heavily by its Irish operations. Currently a new requirement has arisen at this site for a Senior Manager Product Developent/Formulation whichn will play a vital role in the organisations product development.
- Lead CMC activities on assigned development programs.
- Specify the technical requirements for the development program, including performance criteria, control strategies, materials, analytical methods, test protocols, specifications, packages (clinical and commercial) and manufacturing methods.
- Manage remotely, ongoing technical programs at CMOs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors.
- Facilitate and drive resolution of technical issues in a timely manner, driving action items and follow up.
- Ensure accurate tracking and reporting of project deliverables and milestones, maintaining consistent project documentation and preparing periodic updates for Sr. Mgmt.
- Prepare and author, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND and NDA filings for the products that they manage.
- Assist other department team members in reviewing documents on other projects (protocols, reports, regulatory filings, specifications and the like).
- Support Technical Operations to ensure a smooth transfer of technologies and products into commercial manufacturing.
- Create intellectual property covering pharmaceuticals products.
- Drive Innovation and proof of concept activities.
- The preferred candidate will have a strong relevant academic profile (Pharmaceutical sciences, Chemistry, Pharmacy, Process Engineering, Pharmacy) along with at least three years proven track record in leading pharmaceutical product development programs.
- Alternatively, they will be qualified to PhD level (ideally in pharmaceutics, pharmacy, chemistry or chemical engineering) and will possess a strong insight into drug formulation and combination product development.
- Direct experience of pharmaceutical development, QbD and target product profiling. Experience with sterile parenteral and sustained release products would be preferable, along with drug product device combinations technologies (pre-filled syringes, autoinjectors, etc).
- Direct experience with authoring, reviewing and compilation of documentation for CMC regulatory filings for pharmaceutical products.
- Broad exposure to multiple pharma technologies and knowledge of standard dosage forms.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.