Job Title: NPI Operational Lead
12-month contract role (Possibility of Extension)
Location: Dublin
Department: Manufacturing Operations
About the company: Innopharma Technical Services, part of Innopharma Group, is seeking a New Product Introduction (NPI) Operational Lead to provide support to our multinational Biopharmaceutical client site based in Dublin.
About the position:
The Operations Lead will participate in a strategic role and serve as the primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or Capital Expenditure projects and established process improvement projects. This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.
This is an individual contributor role and is primarily based on-site.
Key Responsibilities:
· Function as the site interface between the Product Delivery Teams and Manufacturing operations.
· Engage with staff members within the Manufacturing department to ensure understanding of the processes and work collaboratively cross-functionally with Facilities & Engineering, Quality, PD and Supply Chain.
· Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection.
· Develop, review and update Production, Engineering, Operating Procedures & training materials.
· Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
· Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
· Support scheduling and execution of Characterisation, Engineering and PPQ runs, ensuring all necessary prerequisites are included on the schedule and assess process performance by observation of floor operations and review of performance data.
· Provide troubleshooting support throughout the project and on the floor during execution of activities.
· Hold people to account for delivery and behaviours within the Manufacturing Support team and associated with the project(s).
· Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
· Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects.
· Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences.
· Develop, review and update protocols for manufacturing activities.
· Document and approve protocol deviations for manufacturing activities.
· Consult with Process Development, Direct Manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner.
· Own and lead change controls as required by the Manufacturing Support team.
· Review Bills of Materials.
· Develop, review and update Product Quality Risk Assessments.
Relevant Experience:
· Bachelor’s degree in a science discipline.
· 5+ years of biopharmaceutical manufacturing experience in Fill/Finish or related manufacturing, or GMP experience in the pharmaceutical or medical device industry.
· Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Knowledge/ Skillset:
· Strong project management and organisational skills, including ability to follow assignments through to completion.
· Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity.
· Negotiation and influencing skills.
· Takes initiative to identify and drive improvements.
· Excellent verbal and written communication skills: Strong technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good presentation skills.
· Escalate issues professionally and on time.
· Decision-making skills and confidence to challenge others on decisions that impact the manufacturing area.
· Teamwork and coaching others.
· Ensures compliance within the regulatory environment.
· Demonstrated ability to work independently and deliver right first-time results under minimal direction.
Note:
· Due to the nature of the business, additional duties may be assigned from time to time.
· All applicants must be eligible to work in Ireland on valid working visa for the duration of the contract.
Benefits:
Ability to commute/relocate:
- Dublin, County Dublin: reliably commute or plan to relocate before starting work (preferred)
Education:
Experience:
- Manufacturing operations: 4 years (required)
- NPI Operations: 3 years (preferred)
- Tech Transfer: 3 years (preferred)
- CapEx projects: 3 years (preferred)
- Fill/Finish Drug Product processing: 3 years (preferred)
Work authorisation:
Work Location: In person
