Technical integrator

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Vaccines & Prevention we are searching for a Technical integrator.

As Technical Integrator Analytical Development, you ensure technical representation of the line organisation in CMC project teams. You co-ordinate project deliverables in close collaboration with the CMC Team Lead (CMC TL) and functional line management.

Key Responsibilities
  • Represent Analytical Development on the CMC team, acting as a single point of contact for the CMC Team Leader (CMC TL) and Line Manager (LM).
  • Lead a functional sub-team containing other functional reps and Subject Matter Experts (SME) and are 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);
  • Develop the project functional strategy (Analytical Development) in consultation with the line ensuring to the fullest possible extent the leverage of expertise gained in other projects (re useable knowledge), Develop the plan in alignment with CMC team/TPP;
  • Ensure alignment and endorsement of CMC strategy within the functional line organisation. Highlight 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;
  • Drive 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 organisation to mitigate project incurred delays arising from factors like technology and/or operational execution risks;
  • Responsible for the continuous optimisation 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-ordinate and collate any activities relating to the review process within the functional sub teams and ensures consistency in content;
  • Responsible for co-ordination of spec setting process for functional area on behalf of CMC lead.

Profile

The ideal candidate has an M.Sc. or Ph.D. in Chemistry, Pharmacy, or life sciences with at least 8 years pharmaceutical industry experience preferably in a biopharmaceutical drug development environment. You have proven technical expertise in:
  • 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, product characterisation;
  • Knowledge of other CMC activities (Drug substance/Drug product);
  • Vaccine or viral vector experience Skills.

GMP and regulatory process experience is required. You are able to lead multidisciplinary teams of professionals and foster team productivity in a matrix environment. You have excellent communication skills in English, Dutch is a plus. Finally, you have organisational sensitivity and conflict resolution and planning skills.
Are you the Project Manager we are looking for?

Benefits

Full time preferred, 32 hours minimal. Must be available on-site at least 3 days per week, with flexibility to switch days. Dutch is not a requirement, but strong English communication skills are vital. Extension is anticipated.

Company profile

Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.

Location

Leiden

Company

CLS Services

Publication date

08.11.2019

Publication end date

07.01.2020

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