Biotecnologia ofertas em Espanha

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.

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).