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Head of CMC & Supply to a listed and innovative pharmaceutical company in Lund
Background
As Head of CMC & Supply you will be responsible for leading internal and external CMC activities and directing our proprietary programs towards advancement 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. 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 at least an M.Sc. degree, preferentially a Ph.D., in a relevant Life Science field, most likely weighted towards Pharmaceutical Science or Chemistry, with several years of experience from production of pharmaceuticals, including quality, regulatory, project management, and process development.
A proven track record in project management at senior level is of importance, as well as leadership experience with focus on coaching and development.
We are looking for a driven, structured, self-motivated and responsible leader, who easily collaborates and communicates with others, both 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
• PhD or MSc in a relevant discipline, e.g. pharmaceutics, medicinal- and/or analytical chemistry
• 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 managing selection, evaluation, and contracting of 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
Key responsibilities
• Provide strategic and technical leadership to manage GMP production, including quality- and regulatory documentation, process development, and manufacturing activities
• Establish, manage, and lead the CMC development plan in sync with clinical and non-clinical activities and needs and in good collaboration with key managers
• Identify, evaluate, and contract with CDMOs, consultants, and other vendors as required based on technical and business needs
• Oversight of strategy, planning, and execution of CMC projects at CDMOs, monitor daily activity and implement solutions to solve problems and ensure cGMP compliance
• Ensure excellent collaboration with internal and external stakeholders
• Manage, review, and approve essential regulatory and quality documents, draft CMC sections in IND/IMPD/CTA/NDA
• Propose and manage key process improvements, initiate technical investigations as required to maintain quality and process stability
• Establish plans and implement actions for product characterization and documentation over time, initiate analytical development as required
• Draft, review, and provide input to documents for correspondence with competent authorities and potential partners
• Contribute in grant applications and other financing activities as required