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Analytical & Stability Hub Lead
hace 3 meses
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The Global Analytical & Stability Hub Lead is responsible for fostering a culture of collaboration, empowerment, and shared accountability within the Analytical Development and Stability Hubs across the entire BCH enterprise.
This role plays a critical part in ensuring the quality and compliance of analytical testing processes, methods, and stability studies for all products developed and manufactured by BCH.
Major Tasks & Responsibilities Develop and implement analytical methods and procedures for product testing, ensuring compliance with regulatory requirements and industry standards.
Oversee the validation and qualification of laboratory instruments and equipment, ensuring proper functionality and accuracy.Monitor and ensure compliance with relevant safety guidelines and regulations within the analytical development and lab stability areas.
Stay updated with regulatory changes, the latest advancements in analytical and stability techniques, technologies and identify opportunities for their implementation within the organization.
Collaborate closely with cross-functional teams, including Research & Development, Quality Assurance, and Manufacturing, to drive alignment, coordination, and shared responsibility for product development, quality, and continuous improvement initiatives.
Manage relationships with external vendors and contract research organizations, ensuring effective collaboration and timely delivery of services.Establish and maintain relationships with external partners, contract research organizations (CROs), and regulatory agencies, representing the Analytical Development and Stability Hub and actively engaging in industry forums and collaborations.
Drive innovation and the adoption of advanced technologies, analytical techniques, and best practices within the lab, leveraging external partnerships and collaborations to enhance capabilities and stay at the forefront of industry advancements.
Guide, coach and support a team of analytical scientists and technicians, and other lab personnel, to achieve departmental goals and objectives, fostering a culture of ownership, excellence, collaboration and continuous improvement.
Work Relationships * R&D Technical Excellence and R&D Operations LT- R&D Center of Excellence Hubs Heads
- CMC-D
- E2E PS (including CMOs)
- Octopus teams
Master's degree or higher, in a relevant scientific field (e. g. , Chemistry, Biochemistry, Biotechnology), or international equivalent, with +8 years of proven experience in analytical development, stability testing, and laboratory management within the pharmaceutical or biotechnology industry.
Ph. D. degree, in a relevant scientific field (e. g. , Chemistry, Biochemistry, Biotechnology), or international equivalent, with +4 years of proven experience in laboratory management within the pharmaceutical or biotechnology industry.
Demonstrated experience of at least 5 years leading wide and multidisciplinary Analytical teams within the pharmaceutical industry.
Skills and competencies and qualifications * Proficiency knowledge in analytical techniques such as HPLC, GC, dissolution testing, and spectroscopy.
- Expert knowledge in analytical instruments usage, statistical analysis software and data management systems.
- Expert knowledge of Global Regulatory requirements and quality standards related to quality control, analytical development and stability testing for different kind of pharmaceutical forms.
- Expert knowledge of laboratory safety practices and procedures.
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively across global teams, to foster collaboration, open communication, and shared ownership among team members and stakeholders.
- Excellent English and Spanish communication skills, both written and verbal. Other languages are a plus.
- Strong strategic thinking. Excellent problem-solving and decision-making abilities, with a focus on quality, compliance, and shared accountability.
- Strong attention to detail and project management skills, including the ability to prioritize, plan, and execute multiple projects simultaneously in a collaborative environment.
Reference Code:
Division:
Consumer Health Location:
Spain : Comunidad de Madrid : Alcalá de Henares (Madrid)
Functional Area:
Chemical R&D
Position Grade:
VS 1. 3
Employment Type:
Regular Work Time:
Regular
Contact Us Address Telephone E-
Mail Job Segment:
R&D, Pharmaceutical, Testing, Compliance, Chemical Research, Research, Science, Technology, Legal, Engineering
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SAP as service provider
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