Technical Integrator Drug Product Development
Title: Technical Integrator
Department: Drug Product Development (DPD)
Reporting lines: Reports to Head of DPD Technical Integrator Team
- Ensure technical representation of the line organization in CMC project teams.
- Co-ordination of project deliverables in close collaboration with the CMC Team Lead (CMC TL) and functional line management.
- Maximize the generation and use of knowledge to not only support project objectives but also grow departmental functional expertise (re-useable know how).
- Although TI is defined as a job, it is also possible for a “Functional TI” role to be fulfilled by an individual suitably qualified for the position in which it serves to support personal development opportunities.
- Typical candidates for the role are generally working as Senior Scientists or as very experienced Scientists with a proven, relevant technical background for the function in at least one of the following disciplines:
- cell culture,
- downstream purification (DS),
- aseptic fill/finish and/or formulation development (DP),
- process engineering,
- process analytics,
- CMC Regulatory.
- Candidates are also required to have leadership and communication skills.
- Represents the functional area (DPD) on the CMC team, acting as a single point of contact for the CMC Team Leader (CMC TL) and Line Manager (LM),
- Leads a functional sub-team containing other functional reps and Subject Matter Experts (SME) and is responsible for the planning and executing of functional project deliverables in close collaboration with the line to the desired cost and quality level,
- Responsible for project related functional area deliverables during all CMC stage gate phases,
- Responsible for functional budget alignment (CMC project to line resource owner),
- Fully develops the project functional strategy (DPD) in consultation with the line ensuring the leverage of expertise gained in other projects (re-useable know how),
- Develops the plan in alignment with CMC team / TPP,
- Ensures alignment and endorsement of CMC strategy within the functional line organization,
- Highlights gaps and or deficiencies in departmental functional strategies and or infrastructure (using expertise of SME and or functional reps) and engages line management to address these gaps when conflicting/hindering project objectives,
- Drives partnership and collaboration between the functions and ensures that the customer (internal & external) requirements are well understood by their teams and are used as main drivers for development,
- Responsible for successful functional process technology transfer to the plant / CMO including process-fit -to-plant activities,
- Responsible for maintaining oversight and control over activities at CMO,
- Responsible for the co-ordination of all sub-team activities required to support the governance model (e.g. STR), including the active tracking and monitoring of stage gate deliverables and the integration of the stage gate deliverables into the functional project team,
- Responsible for the generation of appropriate risk management scenarios in close consultation with the sub team, functional SME, and line organization to mitigate project incurred delays arising from factors like technology and/or operational execution risks,
- Responsible for the continuous optimization and streamlining of the project development timelines in close collaboration with the project sub team, SME, and line,
- Responsible for ensuring that adequate technical content review of regulatory submission (module 3) has taken place by the appropriate SME. Co-ordinates and collates any activities relating to the review process within the functional sub teams and ensures consistency in content,
- Responsible for coordination of spec setting process for functional area on behalf of CMC lead,
- Ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
Key Performance Indicators:
- Creation of operational planning, agreement of and adherence to timelines,
- Responsible for functional budget management within CMC project and alignment with LM,
- Sub-team leadership for on time project deliverables in functional sub teams,
- Adherence to functional strategies of the line,
- Timely escalation of conflicts affecting ability to meet project deliverables,
- Demonstrates the re use of knowledge between projects.
Specific professional/technical requirements:
- Education: Nominally a Degree, preferably masters/PhD in Chemistry, Pharmacy, or equivalent life sciences degree,
- Languages: English. Ability to speak Dutch or German is a plus,
- Specific Knowledge: Proven technical expertise in DPD, broad knowledge of the pharmaceutical industry and knowledge of functions involved in drug development / commercialization process, GMP and regulatory process experience is required,
- Experience: A minimum of 8 years pharmaceutical industry experience preferably in a biopharmaceutical drug development environment.
- Ability to lead multidisciplinary teams of professionals and foster team productivity in a matrix environment,
- Excellent written and verbal communication skills,
- Proven organizational sensitivity and conflict resolution and planning skills,
- Teamwork, team development and project management skills,
- Stakeholder (SME, Line, CMC TL, CMC team members, functional area colleagues, Manufacturing, external testing) management,
- Role model.
Janssen Vaccines & Prevention BV (8852)Job Function
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