Prokarium is recruiting for an experienced VP, CMC Manufacturing to join our diverse and high- performance team. Under the direction of the Chief Executive Officer (CEO) you will lead our CMC manufacturing efforts with an initial focus their lead microbial immunotherapy program for the intravesical treatment of non-muscle invasive bladder cancer (NMIBC). We are looking for an established leader with extensive experience in biopharmaceutical development to lead the development and execution of our CMC strategy to commercialize Prokarium’s live biotherapeutic products.
Based in central London, you will be a vital part of shaping and executing development plans through early clinical development.
- Industry experience in the pharmaceutical sector developing biotherapeutics and vaccines from microbial based systems. Experience with live microbial products would be highly desirable.
- Working experience of at least 10 years in the pharmaceutical development/manufacturing sector. SME and CDMO industry experience are highly desirable.
- Create and maintain CMC plans, timelines, agendas, budgets, resourcing requirements, rollingsummaries, and other tools to facilitate planning and coordination of deliverables for the project/program
- Manage in-house CMC team and lead interactions with CDMOs/CROs
- Be the strategic CMC member of cross functional project teams (made up from clinicaldevelopment, translational research, preclinical development and regulatory affairs) to deliver regular CMC updates;
- Deliver project/program updates to project team and/or to senior leadership as necessary, andparticipate in strategic project related operational working groups to provide regular CMC updates
- Responsible for managing budgets at operational level, project and department level, including outsourcing budgets
- Responsible for identifying areas of risk within each project and collaborate with the projectteam to propose and implement risk mitigation strategies
- Under the direction of the management team and General Counsel, manage contracts withCROs and CDMOs for outsourced activities, including contract changes, issue resolution, contract clarifications, and milestone tracking; additionally, review and sign-off CDMO documentation (BMRs, SOPs etc)
- Provide technical leadership to implement new technologies and state-of-the-art equipment, with particular focus on delivering “next generation” upstream manufacturing processes for Prokarium’s pipeline programs
- Support CMC Regulatory Adviser with generation of CMC sections of regulatory documentation
- Build additional in-house capabilities as required (e.g. QP support, analytical functions if/when required)
- Be accountable for the creation of the right environment to deliver high performance
- Provide input into Prokarium’s 3- and 5-year strategic plan and yearly product development plans and budget
Qualifications, Experience and Competencies
- MSc or PhD in appropriate life science/engineering subject
- Working experience of at least 10 years in the pharmaceutical development/manufacturing sector. The ideal candidate will have experience in project management, operational planning, and/or contracts management. Experience with IND regulatory submissions and/or Phase 1 clinical trials is particularly desirable.
- Demonstrated people management, planning and organizational skills
- Good understanding of pharmaceutical drug development is required; having additional knowledge of preclinical development is a plus.
- Knowledge of GMP, regulatory aspects, and pharmaceutical regulations.
- Excellent written and oral communication skills
- Must be able to work independently and within team environments
- Ability to prioritize tasks, adapt to shifting priorities, and deliver on projects in a timely manner
- Ability to capture technical discussion in the form of meeting minutes, decision points and action items
- Ability to interact with all levels of management confidently and respectfully.
- Self-managing, assertive, accountable and responsible whenever needed.
- Keen attention to detail; exceptional organizational skills.
- Good time management and prioritisation skills.
- Strong team player and ready to support his/her co-workers and peers
- Fluent in spoken and written English
- Proficient in relevant software: MS Project or other project management software, Excel, PowerPoint, Word, Access, etc. in addition to general knowledge with shared work environments
Desirable experience or know-how
- Experience of interaction with regulators, especially the FDA, MHRA and EMA
- Specific experience working with live biotherapeutic products (LBPs) and related enabling technologies
- Specific experience of working with lyophilised formulations
- Specific experience developing LBPs or biologics for the treatment of solid tumours (e.g. oncolytic virus development)