Senior Java Engineer - Remote

buscojobs España; Valencia; A distancia; EUR 50.000 - 90.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Lead for their Innovation, Portfolio & IP department. This pivotal role involves coordinating technical development for B2B projects, collaborating with various internal and external stakeholders, and ensuring successful drug product and manufacturing processes. The ideal candidate will possess a strong background in pharmaceutical R&D and technology transfers, with excellent communication and project management skills. Join a dynamic team where your expertise will contribute to groundbreaking advancements in the pharmaceutical sector and drive the success of innovative drug products.

Formación

• Proven experience in Pharmaceutical R&D and Technology Transfers.
• Excellent communication and decision-making skills are essential.

Responsabilidades

• Lead and coordinate technical development of external R&D projects.
• Collaborate with internal departments and manage project timelines.
• Support Tech Transfer activities and assist in regulatory dossiers.

Conocimientos

Pharmaceutical R&D

Technology Transfers

Project Management

Regulatory Affairs

Analytical Method Development

Communication Skills

Interpersonal Skills

Educación

Degree in Pharmacy

PhD in Biotechnology

Descripción del empleo

Lead

The Department : Innovation, Portfolio & IP

The Role :

Reporting to the Head of R&D and CMO, and assisted by Project Management, the candidate will lead and coordinate the technical development of Intas B2B external projects, including external R&D developments and tech transfer activities, to achieve successful drug products and manufacturing processes. The role also involves providing technical assistance on regulatory consultations and external clinical development during drug product development.

The Successful Candidate Will :

• Coordinate and lead the development of assigned projects with external CDMOs, CROs, API suppliers, and consultancy companies.
• Collaborate with internal departments such as Portfolio, Project Management, BD, IP, Regulatory Affairs, QC, QA, and Operations.
• Develop Target Product Profiles, Development Plans, and Scale-up Strategies.
• Work with Project Managers to manage project scope, timelines, milestones, risks, and costs.
• Report project status to the Head of R&D and CMO, and other stakeholders.

Manage CDMO activities across formulation, analytical method development, and validation stages, defining CMA, CPP, and CQA for FDF.

Assist in selecting and expanding capabilities of external partners for development and manufacturing.

Evaluate new technologies for AVM projects and suggest potential products.

Support Tech Transfer activities to external CMOs or internal manufacturing sites.

Contribute to feasibility analysis, validation, and business expansion of new projects.

Support patent studies and patent preparation related to R&D developments.

Assist in completing regulatory dossiers and provide technical justification during evaluations.

Supervise external CROs during clinical development activities.

Support Business Development with technical queries related to development, manufacturing, and quality.

Develop new cooperation models and identify growth opportunities with customers and B2B partners.

Assist Operations in cost and process time optimization during tech transfer and manufacturing.

Collaborate with QA and QC on analytical method development, transfer, and implementation.

Qualifications include proven experience in Pharmaceutical R&D and Technology Transfers, with a results-oriented, proactive, and detail-focused approach. Excellent communication, interpersonal, organizational, and decision-making skills are essential. The candidate should be a team player comfortable working independently, holding a degree in Pharmacy or Biotechnology, preferably with a PhD.