(exciting young Dublin based pharma start up)
This is a rare opportunity to join a young, exciting highly ambitious pharmaceutical company.
Our client is a specialty pharmaceutical company focused on providing therapies to patients with rare diseases. Their seasoned management team has a broad range of experience in commercialization, acquisition, licensing, formulation and product development. The company is currently developing products through late-stage development and regulatory filings. This role will play a key part of coordination and assisting the management of development programs to achieve milestones on-time and on-budget.
The skillsets associated with this role include expertise in development program project management, CMC expertise including analytical, formulation, manufacturing and technical writing to support development reports and required regulatory authorizations. Additional experience in bioanalytical method development and validation is a plus. Lastly, this role will ultimately take responsibility for analytical direction and assisting contract development and manufacturing organization in the development of a robust analytical program to support development and commercialization of the company’s product development portfolio.
- Assist in the coordination and management of product development portfolio and process to ensure budgets and timelines are met. Prepare periodic updates to management.
- Assist in the identification of external vendors or internal partner organizations to enable the most efficient and effective process to complete development.
- Responsible for the analytical/bioanalytical development and validation programs supporting product development portfolio across chemistry, non-clinical and clinical programs.
- Support commercial pipeline by assisting QA during technical investigations and define appropriate corrective and preventative actions when required.
- Assist in technical solutions for formulation development, manufacturing and other CMC related items.
- Preparation of Product development SOPs, guidance documents and technical reports.
- Create supporting reports/documents as required to aid Regulatory authorization submissions related to projects
- Interact with cross functional stakeholders on a regular basis to provide updates on progress of all programs, including challenges and changes to the program necessary to reach approval.
- Perform vendor assessment and selection to support product development portfolio. This responsibility will also require vendor audit support if requested.
- Domestic and international travel to manage vendor relationships and internal relationships to maximize the success and speed of the programs.
- Bachelor’s degree in a technical field. Graduate degree strongly preferred.
- 6 years+ product development experience in pharmaceutical, biotech or specialty pharma companies
- Knowledge of a wide variety of vendor capabilities and prior contacts and working relationships already established
- Strong and proven technical and interpersonal skills
- Successful track record of building constructive relationships with functional stakeholders and team members including management, peer-group, and cross – functional team members/reports
- Excellent oral and written communication skills
- Significant experience in the technical aspects of analytical and drug development
- Knowledge of the FDA/ICH regulatory requirements to obtain approval for pharmaceutical and medical device products
- Project management skills to include day to day running of program activities, keeping program on time/budget and escalating risks/opportunities when arise to Manager.
- Demonstrated ability to accurately gauge the urgency of an issue and proactively manage the actions required to make successful decisions within aggressive timelines
- Demonstrated good judgment and capable of solving complex problems
- Willingness and appetite for travel
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