The Department : Innovation, Portfolio & IP
The Role : Reporting to the Head of R&D and CMO, and assisted by Project Management, to lead and coordinate the correct technical development of Intas B2B external projects, related to either external R&D developments or tech transfer activities, towards obtaining a successful drug product and manufacturing process. Also, during drug product development, to provide technical assistance concerning regulatory consultations and external clinical development.
The Successful Candidate Will :
* Coordinate and lead the development of Intas B2B assigned projects with external CDMOs, CROs, and other key players such as API suppliers and Scientific and Regulatory consultancy companies.
* Interact and align with in-house key departments such as Portfolio, Project Management, BD, IP, Regulatory Affairs, QC, QA, and Operations.
* Develop Target Product Profile, Development Plan, and Scale-up Strategy.
* Align with Project Manager to control project scope, timelines, milestones, risks, and costs.
* Report status of assigned projects to Head of R&D and CMO, and to other key internal and external stakeholders.
* Manage the CDMO during all the different stages of formulation and analytical method development (pre-formulation studies, formulation, stability studies, scale-up, clinical, validation batches). Lead the definition of CMA, CPP, and CQA for FDF.
* Assist R&D and CMO Team in CDMO search and selection of potential partners and expand development and manufacturing capabilities and capacities.
* Assist R&D team in the evaluation of new technologies to be used in the AVMs projects (innovative and differentiated technologies and drug delivery platforms) and suggest potential products for these technologies.
* Assist R&D and CMO Team in managing the technical aspects related to Tech Transfer activities to external CMOs or to own manufacturing sites.
* Assist Portfolio team in feasibility analysis, validation of potential new AVM or Generic projects, increase product portfolio and business expansion.
* Support IP team in patent studies and patent preparation in activities related to R&D developments.
* Assist Regulatory team concerning the completion of the regulatory Dossier for external R&D projects. Also, support Regulatory team with technical justification and documents requested by Health Authorities during Dossier evaluation.
* Assist Head of R&D and CMO in managing and supervising the external CRO during the clinical development activities.
* Support Business Development team in technical questions (development, manufacturing, quality) related to API and FDF received from clients.
* Assist Business Development and Portfolio teams to develop new cooperation models and identify new growth opportunities with customers and B2B.
* Support the Operations team in optimizing costs and process times during technology transfer and routine product manufacturing.
* Assist Operations and QA teams in technical troubleshooting, resolving technical issues, and implementing process improvement and correction actions.
* Cooperate with QA and QC teams in the development, transfer, and implementation of analytical methods in-house and in external companies.
Minimum Requirements :
* Proven experience within Pharmaceutical R&D and Technology Transfers.
* Able to demonstrate that he / she can deliver results.
* Proactive and tenacious with the ability to follow-up.
* Proven ability to deal with complexity.
* Excellent communication and interpersonal skills, able to liaise with stakeholders at all levels and navigate cultural differences with ease.
* Strong organization and administration skills with the ability to make good decisions, have a strong eye for detail, and prioritize a busy workload to meet deadlines.
* Good team player, but equally happy working autonomously.
* A degree-level qualification in Pharmacy or Biotechnology (preferably with a PhD degree).
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