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A very important research and development institution has decided to create a new independent commercial company to sell its own products, currently marketed by third parties worldwide and to launch new product lines already developed. More than 90% of sales are generated in foreign markets.
Our client is looking for a BD Director with experience in the research products market, especially in preclinical development, to lead the Sales & Marketing department. This position is located in Barcelona.
Key Responsibilities:
- Management of worldwide accounts (Europe, USA and Japan).
- Optimize the current go-to-market strategy.
- Perform consultative selling and lead technical homologation in each new customer.
- Prepare and implement annual sales budget and commercial terms and strategy in each country.
- Retain existing customers, expand customer base and launch new products.
- Manage the sales force and customer service.
- Develop web-based sales.
Required Qualifications & Experience:
- University degree in Life Sciences.
- Proven sales experience in the research market.
- International sales experience is highly valued.
- Fluency in English and Spanish required.
We offer:
- Build and launch a new commercial business with the support of a major research and development organization.
- Products already sold worldwide.
- Many development opportunities.
Our client's platform technology enables the efficient delivery of large genes using adeno-associated vectors (AAV). The company overcomes one of the main limitations of AAV, which is their small packaging capacity, allowing the development of treatments for several diseases for which there are currently no treatments. The company has completed the largest Series A financing ever in the Spanish biotech sector.
Our client is looking for a Quality Assurance Manager, with experience in pharma / biotech who, reporting to the VP of QA & RRAA will be responsible for establishing and developing quality systems and shaping the quality culture of the organization in their headquarters in Barcelona.
Main Responsibilities:
- Establish a culture of compliance and collaboration through the implementation and improvement of quality processes.
- Oversee and manage all GxP Quality tasks with input and support from external QA consultants/specialists as required.
- Lead the development of pharmaceutical quality systems - aligning policies, processes and procedures for internal and outsourced activities.
- Preparation of Quality Documents (e.g. SOPs, Policies, Forms and Templates) in conjunction with Subject Matter Experts as required.
- Assure that all outsourced manufacturing activities and product testing are appropriate and conducted in accordance with company policies and GxP standards.
- Ensure quality agreements with key suppliers and partners are complete, approved and updated at appropriate intervals.
- Provide guidance on investigations and corrective and preventive action (CAPA) plans for compliance issues and/or observations.
- Support development of company training programs for GxP-related procedures, practices and system requirements.
- Remain current with quality management trends and ensure that the company’s quality systems evolve accordingly.
- Lead the Quality Management Review Process.
Required Qualifications & Experience:
- Degree in biopharma or related field
- Minimum 5+ years in Quality Assurance in the pharma/ biotech industry.
- Experience establishing and/or enhancing development of GxP quality infrastructure and systems compliant with EU and US regulations.
- Experience in overseeing GMP manufacturing activities at CDMOs (experience of Biologics, preferably ATMPs and advantage).
- Experience of GCP and/or GMP inspections.
- Extensive knowledge of EU and US GMP, GCP and GLP.
- Knowledge and experience in negotiating quality agreements and managing vendor relationships and performance.
- Knowledge of quality risk assessment and management methodologies, including successful application and risk remediation an advantage.
- Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific, medical and operations staff.
- Fluency in English, and Spanish is also preferred.
A very important research and development institution has decided to create a new independent commercial company to sell its own products, currently marketed by third parties worldwide and to launch new product lines already developed. More than 90% of sales are generated in foreign markets.
Our client is looking for a BD Director with experience in the research products market, especially in preclinical development, to lead the Sales & Marketing department. This position is located in Barcelona.
Key Responsibilities:
- Management of worldwide accounts (Europe, USA and Japan).
- Optimize the current go-to-market strategy.
- Perform consultative selling and lead technical homologation in each new customer.
- Prepare and implement annual sales budget and commercial terms and strategy in each country.
- Retain existing customers, expand customer base and launch new products.
- Manage the sales force and customer service.
- Develop web-based sales.
Required Qualifications & Experience:
- University degree in Life Sciences.
- Proven sales experience in the research market.
- International sales experience is highly valued.
- Fluency in English and Spanish required.
We offer:
- Build and launch a new commercial business with the support of a major research and development organization.
- Products already sold worldwide.
- Many development opportunities.
Our client's platform technology enables the efficient delivery of large genes using adeno-associated vectors (AAV). The company overcomes one of the main limitations of AAV, which is their small packaging capacity, allowing the development of treatments for several diseases for which there are currently no treatments. The company has completed the largest Series A financing ever in the Spanish biotech sector.
Our client is looking for a Quality Assurance Manager, with experience in pharma / biotech who, reporting to the VP of QA & RRAA will be responsible for establishing and developing quality systems and shaping the quality culture of the organization in their headquarters in Barcelona.
Main Responsibilities:
- Establish a culture of compliance and collaboration through the implementation and improvement of quality processes.
- Oversee and manage all GxP Quality tasks with input and support from external QA consultants/specialists as required.
- Lead the development of pharmaceutical quality systems - aligning policies, processes and procedures for internal and outsourced activities.
- Preparation of Quality Documents (e.g. SOPs, Policies, Forms and Templates) in conjunction with Subject Matter Experts as required.
- Assure that all outsourced manufacturing activities and product testing are appropriate and conducted in accordance with company policies and GxP standards.
- Ensure quality agreements with key suppliers and partners are complete, approved and updated at appropriate intervals.
- Provide guidance on investigations and corrective and preventive action (CAPA) plans for compliance issues and/or observations.
- Support development of company training programs for GxP-related procedures, practices and system requirements.
- Remain current with quality management trends and ensure that the company’s quality systems evolve accordingly.
- Lead the Quality Management Review Process.
Required Qualifications & Experience:
- Degree in biopharma or related field
- Minimum 5+ years in Quality Assurance in the pharma/ biotech industry.
- Experience establishing and/or enhancing development of GxP quality infrastructure and systems compliant with EU and US regulations.
- Experience in overseeing GMP manufacturing activities at CDMOs (experience of Biologics, preferably ATMPs and advantage).
- Experience of GCP and/or GMP inspections.
- Extensive knowledge of EU and US GMP, GCP and GLP.
- Knowledge and experience in negotiating quality agreements and managing vendor relationships and performance.
- Knowledge of quality risk assessment and management methodologies, including successful application and risk remediation an advantage.
- Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific, medical and operations staff.
- Fluency in English, and Spanish is also preferred.
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