Technical Services Director
4 days ago
Job Title: Technical Services Director
Job Summary:
We are seeking a highly skilled Technical Services Director to join our team at Piramal Group. As a key member of our Technical Services Group, you will be responsible for the development, scale-up, and commercialization of parenteral pharmaceutical products.
Key Responsibilities:
- Design, project manage, implement, enhance, and validate new and existing systems, processes, and equipment to support the transfer of new products from R&D to clinical and commercial manufacturing.
- Manage a team of process engineers to tech transfer new products and develop the product for commercial manufacturing, including the development and challenging of critical quality parameters and attributes (CPPs and CQAs).
- Develop robust and repeatable commercial processes.
- Design and select fit-for-purpose equipment, processes, and technology to ensure reliable and repeatable processes that can be easily followed by the manufacturing operations team.
- Interface with clients and regulators.
- Identify and assign continuous improvement projects.
- Represent the technical subject matter expert (SME) in product development, scale-up, and optimization of new products.
Requirements:
- Bachelor's degree in mechanical, biological, chemical engineering, or equivalent years of field experience.
- 5-7 years of working within pharmaceutical manufacturing/development environment, including development of processes and products.
- Formal leadership/management experience.
- Experience working within aseptic or lyophilization manufacturing.
- Contract manufacturing experience strongly preferred.
Functional or Technical Skills:
- Well-versed in quality by design and scale-up of pharmaceutical products.
- Knowledge and understanding of the regulatory approval process for US, EU, and JP.
- Expertise in product scale-up.
- Knowledge and understanding of CGMPs; knowledge of CGMP validation requirements and techniques.
- Knowledge and experience in CGMP CA/PA, root-cause analysis, risk assessment, and investigation tools and techniques.
- Experience managing direct reports.
- Seasoned communicator, ability to interface effectively with all levels of the organization and clients.
- Proficiency using Microsoft Office applications (Word, Excel, PowerPoint).
- Ability to effectively lead cross-functional teams.
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