Technical Scientist - API
* Reporting to the PDMS APILM Manager on site this role will support development projects and manufacturing operations at the facility located in Cork, Ireland. Responsible for leading Technical Transfer, Process Validation, Manufacturing investigations, Life Cycle Management and Health Authority Inspections.
Description of the Role:
* Leads early and late phase Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
* Leads early and late phase product development activities through generation of protocols/reports, execution of laboratory scale studies and participation in Lean Early Development initiatives as required.
* Leads "process fit to plant" during early and late stages of development to provide guidance to both development and manufacturing teams.
* Leads "man in plant" by providing support during manufacturing campaigns for new products or during process validation campaigns.
* Provides expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations.
* Partner with Project Teams to provide input, review and approval support for BLA submissions
Focus and Scope:
* Participate in and/ or Lead cross-functional project teams.
* Interpret project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
* Assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
* Execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
* Foster a culture of Lean and Continuous improvement within the department and with internal and external partners
Critical Experiences Required:
* A minimum of a Bachelor's degree in Biology, Pharmacy or related scientific field is required, advanced degree is preferred.
* Minimum 5 years experience in pharmaceutical or biotechnology industry.
* Biological process development or commercial manufacturing experience, either cell culture and/or purification.
* Excellent communication, skills, both oral and written.
* Capable of planning and executing experiments or projects steps with some supervision.
* Ability to work well in a team environment, strong collaboration skills and flexibility.
* Excellent interpersonal skills with the ability to adapt to rapid changes in project priorities and requirements.
* Collaboration and Teaming
* Integrity and Credo Based-actions
* Results and Performance Driven
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.