Product Development, Manager Dublin
Our client is a young fast growing highly profitable multinational pharmaceutical company with an exciting newly created Manager level appointment in Product Development.
The Product Development Manager works on directing the technical activities for product development programs. The activities may be performed by partners, contractors or company personnel. The range of technologies used for our products that he/she manage will vary from standard pharmaceutical dosage forms to more sophisticated drug delivery, including sustained or controlled-release dosage forms, such as possible novel concepts like combination products (i.e. drug-device).
The Product Development Manager is responsible for overseeing programs from the completion of product feasibility through commercial registration. These programs will typically be late stage programs that require flawless execution because they are critical to commercial success. This position has high accountability in both financial and technical decision-making (program direction and development paths). He/ She will also support the transfer of these programs to commercial manufacturing sites. This position reports to the VP, Technical Operations.
The Product Development Manager will:
- Specify the technical requirements for the products, including performance criteria, materials, analytical methods, test protocols, packages (clinical and commercial) and manufacturing methods.
- Manage ongoing technical programs including developing detailed technical work plans; selecting suitable vendors for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt.
- Prepare, 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 Manufacturing to ensure a smooth transfer of technologies and products to commercial manufacturing sites.
- Create intellectual property covering Company products.
- BS or MS in engineering or science with greater than 10 years of experience or PhD in engineering or science and 7 or more years’ experience in pharmaceutical product development.
- Direct experience with CMC regulatory filings for pharmaceutical products.
- Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms.
- Proven project management skills for technical programs.
- Excellent communication skills and strong interpersonal skills.
- Flexibility to travel on company business when required
- Experience in a number of the following is desired: solid dosage forms, controlled release formulations, combination products, parenteral products, API manufacturing, and analytical chemistry.