Barden are delighted to be supporting our global pharmaceutical client for a Director Process Development Sciences.
The Director of Process Development Services (PDS) bears the responsibility for overseeing process and analytical development endeavors within the Active Pharmaceutical Ingredients (API) business. Their primary duty is to ensure that the manufacturing processes align with the specific development phase or product lifecycle. This role demands a fusion of technical expertise in scientific matters and a sharp business acumen, aimed at ensuring that all products developed, manufactured, or distributed adhere to the necessary legal requirements.
As a vital member on the Site Leadership Team (SLT) at the Cork Site, the Director will provide unwavering support to the General Manager and the SLT across all operational facets and strategic planning. Additionally, the Director will be actively involved in cultivating, guiding, and supervising professionals operating within this business domain.
Roles & Responsibilities:
- The PDS team will be key in interfacing with the customer during the development and technology transfer phase of a project.
- This includes the technology and analytical transfers of the products to the site.
- Process development of the products to ensure that the process is appropriate for manufacture for the phase of development or product lifecycle.
- Analytical development of the methods for testing of raw materials, intermediates and APIs as appropriate for the phase of development or product lifecycle.
- Process validation of new products and lifecycle changes.
- Responsible for the generation of the control strategy and validation and the supporting analytical methods.
- Transfer of products to Operations post commercial validation.
- PDS is responsible for ensuring that the process is fit for commercial manufacture.Transfer of methods to QC for testing of raw materials, intermediates and API at all phases of the product lifecycle.PDS is responsible for ensuring that the methods are appropriate for the phase of development or product lifecycle.Transfer of methods to IPC for in-process control testing of processes at all phases of manufacture and lifecycle.
- PDS is responsible for ensuring that the methods are appropriate for the phase of development or product lifecycle.
- Ensure that the basis of safety is in place for all products and that the appropriate safety testing has been completed for all.
- Technical and analytical troubleshooting and improvements.
- Keep the team up to date with current technologies and manufacturing trends.
- Confirm a robust succession plan in the team for key roles.
- Make sure that there is a strong quality, EHS, PPI and compliance culture across the team.
- Managing the team Opex budget and supporting the planning of the capital requirements for the future.
ABOUT THE PERSON:
Education & Work Experience:
- Minimum requirement of B.Sc Chemistry or B.Eng Chemical Engineering. It is preferred candidates would hold a M.Sc/M. Eng or Ph.D
- Extensive experience in Pharmaceuticals, API manufacturing, BioPharma or similar
- Working knowledge of CDMO would be an advantage.
- Experience in technology transfer
- Experience in process development
- Practical knowledge leading multi-disciplinary teams at a Senior level.
- Budget management
- Demonstrated leader with a solid foundation in Integrity, Involvement, Intensity and Innovation
Hi, we’re Barden. We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.