Description
Material Scientist required to join a global biotech company for an initial 11-month contract in Dublin.The Materials specialist will join the global Materials Science group in the life cycle management of raw materials and consumables utilised for biopharmaceuticals commercial manufacturing operations. The successful candidate will collaborate closely with Manufacturing, Manufacturing Support, Quality Assurance, Quality Control, Supply Chain, and Global Procurement groups on cross-functional teams to review supplier change notifications, complete SAP impact assessments and track project status. This position will be key contributor to a dynamic and highly technical team. As part of MS&T, this position offers the opportunity to provide strong and highly visible leadership of cross-functional teams to address critical business objectives.
Key responsibilities will include:
- Supports materials technology transfer, validation and the preparation of compliance documentation.
- Provides technical expertise and authorship for investigation and resolution of single-use consumables implementation, deviations, change controls and technical documentation in support of commercial manufacturing.
- Perform analytical testing of raw and consumable materials using a range of techniques; HPLC, LC-MS, FTIR, Raman
- Mastery of material and disposable specifications, SOPs, cGMPs and the know how to work and manage within a regulatory environment.
- Leads cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for specification changes, technical assessments, alternate vendor qualifications and change management.
- Provides process subject matter expertise, representing the site, cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc) for facility fit activities, specification changes, technical assessments, alternate vendor qualifications, change management.
- Degree Qualification or equivalent in Material Sciences/Chemical Engineering.
- Awareness of cGMP compliance and regulatory agency requirements.
- Experience performing analytical testing (HPLC, LC-MS, FTIR, Raman).
- Strong oral communication and technical writing skills.
- Demonstrated problem solving ability.
- Statistical Engineering Expertise (SPC, DOE etc.)
- Experience in an operations environment in a Material Science Function within a Biologics company or similar industry would be a significant advantage.
- Proven project management skills, including leading cross functional teams and balancing project assignments.