Our client is a global biopharmaceutical company.
The Senior Drug Substance Development Manager position is responsible for providing strong scientific support to the phase appropriate development of drug substance manufacturing processes. This role requires application of scientific and/or engineering principles to develop into commercially feasible, reliable and robust processes. Activities will be performed primarily with external contract development and manufacturing organisations (CDMOs).
Other responsibilities will include cross-functional team membership, authoring technical reports, supporting CMC aspects of regulatory dossiers, and participation in department or functional initiatives.
The role will involve significant cross functional collaboration with other functions including Development Quality, CMC Regulatory, Manufacturing, working towards agile new product introduction and ensuring all processes are understood, robust, efficient and in control.
Reporting into the Senior Director, DS development within the Small Molecule Team (SMT), this role will provide scientific and technical leadership and support for drug substance development projects at various stages of the development life-cycle.
- Lead the process development and cGMP manufacture of small molecule drug substances at CDMOs and ensure adequate supply of drug substance for clinical studies and other needs.
- Lead the development of robust and reliable manufacturing processes utilizing Quality by Design (QbD) principles.
- Oversee the synthesis of chemical entities to support clinical and non-clinical studies.
- Ensure that all DS processes are in line with all applicable regulations, policies, guidelines and procedures.
- Work closely with other cross-functional CMC project team members to deliver on agreed project goals.
- Contribute to the authoring of drug substance sections of regulatory dossiers and technical reports.
- Support other Technical Operations functions to ensure a smooth transfer of technologies and products to manufacturing sites.
- Coordinate and manage the storage and supply of study materials to both internal and external stakeholders.
- Represent the drug substance team on cross functional project teams as needed.
- Actively contribute to functional area continuous improvement initiatives.
- Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences.
- Support project planning, budgeting, scheduling of assigned projects.
- Continuously develop self-knowledge of new pharmaceutical manufacturing processes and technologies as required in line with business objectives.
- Over seven years of experience in drug development and experience in multiple manufacturing technologies.
- Proven record of achievement in drug substance development and manufacturing.
- Demonstrated technical expertise in chemical process development and new product introduction.
- Ability to effectively participate on multi-disciplinary teams.
- Strong understanding of project management processes, risk management processes, pharmaceutical quality management systems and pharmaceutical regulations.
- Capability of grasping complex technical issues and make sound decisions based on data and information from various sources.
- In conjunction with QA Development ensure that CDMOs are qualified and approved.
- Demonstrated troubleshooting and problem-solving skills.
- Experience of CMC regulatory requirements for pharmaceutical products.
- Proven project management skills for technical programs.
- Experience in managing and maintaining budgets desirable.
- Excellent written and verbal communication skills.
- BSc in Chemistry or Chemical Engineering.
- Advanced degree (MSc, PhD) in Chemistry desirable.
- Project management skills for technical programs is desirable.
- Experience in defending processes, procedures and investigations during FDA/EMA inspections is desirable.
- Experience working with CDMOs/CMO desirable.
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