Job Title
Technical Operations Specialist - Process Development Technician
Location
College Park, Dublin - IRL006
Job Description Summary
Reporting to Senior Manager, Technical Operations and based at College Park Manufacturing Facility (CPMF). TechOps Specialist will perform and oversee multi-step process development, standardisation, and evaluation with an aim of establishing laboratory scale manufacturing modules to solve complex issues related to materials and process related changes. The role involves supporting production activities at the existing manufacturing facility and focusing on development laboratory work for small-scale process replication. The TechOps specialist will collaborate closely with other functions, including Operations, Quality (QA/QC), regulatory, and internal and external stakeholders.
Responsibilities
Work collaboratively in a cross-functional environment, partnering with teams from Operations, Quality, Engineering and Regulatory to ensure timely project execution and support commercial products.
Develop and maintain laboratory scale manufacturing models to attain a deeper understanding of the process and implement process control strategy in the commercial manufacturing environment.
Utilise all chemistry and laboratory tools and techniques (e.g. FTIR, NMR, UPLC/MS, Lyophilisation, Autoclave, extraction and purification etc.) to develop, assess and improve the manufacturing process and pathways.
Carry out feasibility study of the Process, Process Optimisation, Lab Validations, Technology Transfer to plant and identify and evaluate the process parameters.
Analyse experimental data to drive experimental plans.
Assist in the design, planning and execution of multi-step experimental studies guided by risk assessment to deliver safe, efficient, robust and scalable manufacturing processes.
Investigate optimisation and scale-up of reaction and manufacturing unit operations.
Collaborate within project teams by working closely with analytical chemists, process engineers, pilot plant experts and project managers within the organisation.
Communicate scientific results in a clear, concise, and accurate manner via electronic laboratory notebook documentation, development reports, project discussions and presentations.
Draft and review technical reports, external publications and patent applications.
May include management of outsourced laboratory activities: generating scope of work, supervising activities at CMOs, validating reports for outsourced activities.
Serve as Person in Plant for manufacturing campaigns as required.
Lead Tech Transfer projects between CMOs and internal stakeholders.
Author or provide technical review of project documents, validation protocols, batch records, etc.
Act as SME for new material introductions and raw material/component replacement projects.
Department Specific Functions
Provide oversight of interns or contractors in the development lab as needed.
Support the generation of safety risk assessments and the implementation of site EHS policies.
Always ensure adherence to Safety guidelines and ensure immediate escalation and closure of safety risks.
Provide out-of-hours support during projects as required (infrequent, night hours may be required).
Participate in ad-hoc projects, goals and objectives as they arise.
Maintain detailed laboratory notebooks and ensure timely review and witnessing.
Maintain an awareness of literature appropriate to projects.
Maintain an awareness of global regulatory guidelines and apply those to product development strategy.
Minimum Requirements
Education: BA or BS in Chemistry, Biology, Engineering or related science.
Experience: 1-2 years’ experience in a biomanufacturing process related environment; analytical background preferred.
Skills: Good knowledge of chemistry and laboratory tools and techniques (e.g. FTIR, NMR, UPLC/MS, Lyophilisation, Autoclave, extraction and purification). Ability to work independently and adapt to fluid situations. Fluency in English. Proven ability to work in a team. Excellent communication skills, demonstrated leadership experience and technical expertise in scientific laboratory settings. Computer fluency in MS Office Suites. Ability to maintain confidential and sensitive information. Must be flexible and adaptable to accommodate changing challenges of the role.
Competencies
Must possess excellent oral and written communication skills, advanced knowledge of laboratory procedures, advanced problem‑solving skills and technical competency, and the ability to work effectively in a team environment.
Organisational Relationship / Scope
Position directly reports to the Senior Manager, Technical Operations.
Stakeholders
Quality
Internal/External Manufacturing Operations
Regulatory
Working Conditions
This position involves normal office conditions with regular exposure to development laboratory operations. Occasional travel may be required for engagement with external laboratories and collaborators. The role is based at College Park manufacturing facility in Dublin. Extended or out-of-hours work may be required on occasion to support lab work or projects to meet the business needs.
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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