- Reference: 46414
- Job Type: Permanent
- Location: Dublin North, Dublin West, Other
- Category: Science, Pharmaceutical & Food
Technical Manager – Science & Technology
We are currently sourcing a Technical Manager – Science & Technology API Products TPM Manager for our clients a leading bio-pharma multinational. Position will be based from Dublin.
The position holder will be the primary point of contact for technical oversight and support of third party manufacturers producing API, intermediates, and starting materials for our clients.
The API TPM Manager supports development of chemical processes throughout the life cycle of a product from technical transfer of pipeline products steps to commercial support of marketed products.
They work cross-functionally with partners such as R&D, Manufacturing, Quality, Regulatory, Supply Chain, and Purchasing to support the development, transfer and execution of robust chemical processes. In addition, they support products with chemical and process knowledge, risk assessments, technical document generation and review, continuous improvement ideas and implementation, performance assessments such as KPIs and tracking and trending, change control, in plant floor support and general oversight of TPM performance.
Key Responsibilities Include :
- Manage the technical support (product and process expertise) of API manufacturing processes executed at their third party manufacturers. This includes a range of activities, from day-to-day manufacturing problem solving to continuous improvements to performance monitoring.
- Manage the technical portion of product transfers into third party manufacturers including from PRD to TPM, TPM to TPM, and Operations to TPM.
- Manage product investigations. Management and execution can include contributing to and reviewing of project reports and investigations. Make scientific recommendations as to the acceptability and quality of affected product lots and any remediation required.
- Identify and implement process changes to improve product quality and/or reduce processing costs in the manufacturing of TPM produced products. Prepare and review scientific reports and validation/engineering protocols describing and supporting process changes and improvements.
- Contribute and write potential submission documents for governmental regulatory agencies.
- Provide product and process expertise in the execution of plant projects (for example, technical transfer, installation of new manufacturing equipment, process changes) including process validation and cleaning validation.
- Communicate cross functionally to keep product teams and management updated on project status and drive resolution of technical issues
- BS or equivalent education in chemistry or engineering and 10+ years of industry experience, MS or PhD or equivalent education with 6+ years of industry experience.
- Industry experience to include technical experience in API process chemistry including laboratory and GMP/FDA/EMA regulated plant support experience.
- Possesses knowledge and a skill set to operate within a cross-functional environment that requires a high degree of urgency, strong analytical and problem solving skills, and positive interpersonal skills.
- Ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals with demonstrated success as a collaborative team player.
- Proficient in the analysis and preparation of complex scientific data, reports, and global regulatory submissions.
- Must have excellent project management, presentation, oral and written Communication Skills.
- Must have a good knowledge and understanding of global regulatory and compliance requirements relating to CMC related areas.
For a confidential discussion and more information on the role, please contact Mary Mullin on 09064 78104 and email your cv to firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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