Biotech and Agricultural Engineering Management & Business Others Medical and Healthcare Other Science and Tech
Analytical Development Technical Integrator
Janssen Vaccines & Prevention B.V., previously Crucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
Het bedrijf / The company
In the Analytical Development (AD) Department, we are responsible for the development, qualification and validation of analytical methods for QC release and stability testing, product and process characterization, qualification of reference materials and supporting process and formulation development. As Technical Integrator you are a project manager within the department, lead all analytical tasks for a development project but importantly are representing the department for your project(s) in the CMC team. You will join a team of 7 Integrators reporting into the Head of the Analytical Integrators.
Janssen Vaccines & Prevention BV (8852)
De functie / The role
Responsibilities and duties
The AD Technical Integrator has a key role and is very visible both within as outside the department. He or she is involved in a broad set of activities that need to be performed for the development of a candidate vaccine and has interactions with various expertises. In particular:
Represents Analytical Development on the CMC team, acting as a single point of contact for the CMC Team Leader and Line Manager.
Leads a functional sub-team containing other functional representatives and/or 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.
Develops the project functional strategy (Analytical Development) in consultation with the line ensuring to the fullest possible extent the use of expertise gained in other projects (re useable knowledge); develops the plan in alignment with the CMC team strategy and target product profile.
Responsible for functional budget alignment 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 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.
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
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 and ensures consistency in content
Responsible for coordination of the specification setting process on behalf of the CMC lead.
Het profiel / Your profile
The candidate should have a proven experience of 8 years in a biopharmaceutical drug development environment, preferably in an Analytical Development/Quality Control department and broad understanding of functions involved in drug development/commercialization process, GMP and regulatory process experience is required. In particular the following:
Analytical method development and validation
Interactions with regulatory agencies (IND/IMPD, MAA/BLA, briefing documents, etc)
ICH stability studies
Other analytical development activities such as reference materials and product characterization
Vaccine or viral vector experience
The candidate should have the following skills:
Assertive with a can do mentality
Excellent written and verbal communication skills
Confirmed project management skills and the ability to lead multidisciplinary teams of professionals and foster team efficiency in a matrix environment
Organizational sensitivity and conflict resolution skills
The candidate has preferably a masters/PhD in Chemistry, Pharmacy, or equivalent life sciences degree and speaks proficient English. The ability to speak Dutch is a plus.
We are looking forward to see your application.
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Janssen Vaccines & Prevention
Johnson & Johnson
Geplaatst op FMF: 10 november 2020
Branche: Farma & Biotech, Medical Functie: R&D Opleidingsniveau: HBO / BSc, WO/academisch / MSc Werkervaring: 5-10 jaar, > 10 jaar