Director CMC & Supply to a listed and innovative pharmaceutical development company in Lund!

Background

As Director CMC & Supply you will be responsible for leading the company´s CMC activities in support of our programs in clinical development.

The role involves serving as a member of the Management Group at the company in Lund to ensure internal and external cross-functional collaboration to meet business objectives, timelines and priorities.

To succeed in this role, you will have broad managerial and technical experience in regulatory CMC and pharmaceutical development as well as excellent communication skills. You have experience of management of all activities involved in regulated pharmaceutical production processes and supply chain in support of clinical development, including CDMO oversight and coordination. You enjoy working with multiple stakeholders and multi-disciplinary teams to progress development programs, solve technical problems, and ensure appropriate levels of quality and documentation to meet regulatory requirements.

Qualifications

The position requires an M.Sc. or Ph.D. degree in a relevant Life Science field, most likely weighted towards Pharmaceutical Science or Chemistry, with relevant experience from production of pharmaceuticals, including quality, regulatory, project management, and process development.

A proven track record of project management and leadership at senior level is of importance.

We are looking for a driven, structured, self-motivated and responsible leader, who easily collaborates and communicates internally and externally. You have excellent problem-solving skills, have experience of risk-based decision making and contributing with your experience to ensure continuous improvements.

Personal characteristics are of great importance, and we believe that you are efficient, have a strong commitment and ability to make things happen. You are leading by example to support collaboration, participation, and knowledge development; you can inspire and promote a culture of progression, innovation and self-improvement at all levels within the organization.

Education and technical skills

• Academic degree in a relevant discipline, e.g. pharmaceutics, medicinal- or analytical chemistry, biochemical- or chemical engineering

• Extensive industrial experience from drug development and CMC vendor and process management, experience with radiopharmaceutical manufacturing or supply chain will be considered a major advantage

• Experienced in pharmaceutical production, process and analytical development, tech-transfer to external manufacturers and partners

• Documented knowledge of GMP and ICH guidelines, experience with quality systems, auditing, managing and authoring regulatory documents and submissions

• Experience in selection, evaluation, contracting, and managing CDMOs, consultants, and other subcontractors

• Experience with radiopharmaceuticals is a plus

Professional and personal competences

• Ability to strategically and pragmatically manage and work with external collaborators, consultants, and service providers to ensure operational quality

• Organizational, sets clearly defined objectives, monitors performance against budget and milestones, manages time effectively

• Takes own initiatives, works independently, makes clear and well documented decisions, initiates and generates activity

• Creates good relationships, understanding and pragmatic in relation to other people and stakeholders at different levels

• Adapts to changing conditions, fosters new ideas and initiatives

Contact me for more information regarding this exciting position on a highly innovative company in Lund!