Job Title
Technical Operations Specialist
Requisition
JR000015586 Technical Operations Specialist (Open)
Location
College Park, Dublin - IRL006
Additional Locations
Job Description Summary
Reporting to Senior Manager, Technical Operations and based at College Park Manufacturing Facility (CPMF). Technical Operations Specialist will be responsible to 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. Working within the Technical Operations team, Technical operations specialist will also support the production activities ongoing in the existing manufacturing facility and will have considerable development laboratory focus for replication of the process at small scale. The Process Scientist will collaborate closely with other functions, including Operations, Quality (QA/QC), regulatory and other internal and external stakeholders.
Job Description
· Essential Functions
· 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.
· Utilize all chemistry and laboratory tools and techniques (i.e. 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 Optimization,?Lab Validations, Technology Transfer to plant and identify and evaluate the process parameters
· Analyze 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 optimization 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 organization.
· 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.
· Serves as Person in Plant for manufacturing campaigns as required.
· Leads Tech Transfer projects between CMOs and internal stakeholders.
· Authors or provides 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.
Maintains detailed laboratory notebooks and ensures timely review and witnessing.
Maintains an awareness of literature appropriate to projects.
Maintains an awareness of global regulatory guidelines and applies those to product development strategy.
Minimum Requirements
Education / Experience / Skills:
Education:
PhD in Chemistry, Biology, Engineering or related science.
MS in Chemistry, Biology, Engineering or related science.
BA or BS in Chemistry, Biology, Engineering or related science.
Experience:
Science / Engineering degree required; analytical background preferred.
3 - 5 years' experience in a biomanufacturing process related environment.
Have good knowledge of chemistry and laboratory tools and techniques (i.e. FTIR, NMR, UPLC/MS, Lyophilisation, Autoclave, extraction and purification etc.)
Ability to work independently and to adapt to fluid situations.
Fluency in English required
Proven ability to work in a team.
Excellent communication skills, demonstrated leadership experience and technical expertise in Scientific
Laboratory settings
Computer fluency competence in MS Office Suites.
Ability to maintain confidential and sensitive information is required.
Must be flexible and adaptable to accommodate changing challenges of role.
Competencies
Required Skills/Competencies: Needs to possess excellent oral and written communication skills. Advanced knowledge of laboratory procedures is necessary. Individual must demonstrate advanced problem-solving skills and technical competency. Must demonstrate the ability to work effectively in a team environment.
Preferred Skills/Qualifications: Cross-functional knowledge of process chemistry and biomanufacturing is desired. Incorporation of laboratory automation technologies to enhance departmental efficiency is expected. Chemical Design for Six Sigma knowledge is a plus.
Organizational Relationship/Scope
Position directly reports to the Senior Manager, Technical Operations.
Working closely with the key stakeholders, including:
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.
At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.
Invest in your own career with Keenova and let's do something dynamic together.
Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.
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