At Polyphor we value integrity, passion, accountability, creativity, teamwork and open communication.
We strive to build and maintain a working environment where employees can be proud of their achievements and their contributions to the advancement of science, to the development of new therapies for patients, and to the success of Polyphor. We promote further training and education on an individual basis.
To provide safe and healthy workplaces, we are committed to complying with all relevant Health, Safety and Environmental (HSE) laws and legislations.
Senior CMC Specialist
The Senior CMC Specialist is a distinct expert in the CMC area (e.g. process optimization, up-scaling, manufacturing and/or supply chain management), with broad overview of all different aspects along the value chain.
- Establish, manage and lead the CMC development and supply for drug substances and drug products from preclinical through commercial
- Ensure full compliance with all CMC-specific regulatory and quality requirements (externally and internally) supported by internal and external experts and opinion leaders
- Effectively manage external partners and outsourced activities: establish, lead and drive supplier selection (for manufacturing, formulation, analysis, distribution, QP, etc. services), qualification, negotiations, implementation and project controlling (member of joint steering committees, project leader function, sourcing responsibility)
- Lead CMC-relevant interactions with regulatory bodies (FDA, EMA, MHRA, etc.). Actively participate in preparation and attend regulatory meetings and prepare filings (domestic and international)
- Work with Quality Assurance, develop SOPs and guidelines related to the production, planning, materials, disposition and management, etc.
- Direct/oversee contract manufacturing, testing, packaging and labeling and distribution operations for the company’s drug substances and drug products
- Develop production plans and budgets to support preclinical, clinical and commercial development
- Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required
- Manage all electronic archiving of relevant CMC data
- Line management of a small internal group in alignment with external partners to form an effective CMC subteam
- Core member of project team
- Reports to the Chief Development Officer Polyphor Pharma
- You have a BSc. / MSc. or Ph.D. in a relevant discipline (preferably chemistry with focus on process development and/or formulation; peptide manufacturing experience is a plus).
- You have a minimum of 10 years’ experience in CMC project management, development, scale-up and clinical/commercial development and manufacturing in the pharmaceutical industry.
- You have the ability to mobilize internally and externally CMC experts to ensure compliant, high-quality and cost-effective CMC plans and their implementation.
- You show high effectiveness in managing external partners and outsourced activities. Additionally, you have an entrepreneurial personality with a “can do” mindset, and your willingness to take on accountability and responsibility to get a job done is high.
- Your understanding of the entire drug development process and of regulatory and quality requirements associated with CMC is excellent.
- You should be very familiar with GMP, PCH, EMA and FDA regulations and guidelines for CMC.
- You are an excellent and proven leader, have strong managerial and communication skills and are capable of working effectively in a cross-functional environment.
- Your level of proficiency in analyzing scientific data and results and your ability to research and critically review scientific documents including reports, publications and regulatory submissions and draw relevant conclusions is very high.
- You have excellent negotiation skills and you are fluent and professional in English (written and oral communication); additional languages are an asset.
Direct applications are preferred