Associate Director, CMO Operations (Europe)
As a member of the Technical Operations organization, this position reports to the Senior Director, GMP Manufacturing and Technology Development. Throughout the life cycle of the product, the successful candidate will ensure a continuous, integrated knowledge base and understanding of the physical and biochemical properties of the therapeutic product, as well as the manufacturing process and associated analytical control methods. As CRISPR’s “Person in plant” for critical manufacturing steps, a thorough understanding of all process steps and associated in-process controls is required for both autologous and allogeneic products. The role requires observation of processing to ensure compliance with manufacturing instructions, resolving ambiguities and identifying potential Deviations and Exceptions arising during processing, escalating significant issues appropriately in a timely manner. The role requires considerable flexibility to accommodate manufacturing and long shifts and weekend working will be required. Travel to the manufacturing sites is required during manufacturing as well as for reviews, etc. A daily report on manufacturing progress is generally required, highlighting any issues arising in a timely fashion. For some products, multiple CMOs may be used. It is imperative that consistent processes are employed to maintain product quality and regulatory compliance across sites, so effective communication skills are required to avoid divergence of processing between sites. Ensuring that all parties’ interests are respected requires a strong understanding of CRISPR requirements as well as those of our partners to ensure the highest levels of cooperation are maintained.
The quality of our manufacturing data is key to gaining approval for our therapies and maintaining compliance, and this position is key in ensuring consistency. Compilation of data from batch records for inclusion in CMC documents is an essential element of the role. Review and approval of Master Batch Records and Change Control documents is also a requirement, as is review of regulatory submissions.
This position works in close liaison with external manufacturing organizations’ management and staff together with CRISPR Therapeutics Technical Operations, Quality, Regulatory and Development staff.
- To represent CRISPR Therapeutics as our “Person in Plant”
- To ensure that CRISPR Therapeutics’ interests are maintained at our CMOs and that GMPs are maintained
- To identify difficulties in manufacturing that will need short-term remediation or are barriers to long term commercialization goals
- To compile and maintain commercial manufacturing history files for CMOs
- Consult regarding ongoing critical investigational events and technical studies
- Instigate impact assessments of change controls
- Provide on-site guidance to CMOs for upcoming CRISPR Therapeutics requirements
- Acts as chaperone for site visits for partner organizations
- Identify improvement opportunities, both operational and technological
- Advise on process risk profiling as well as identification of required corrective actions
- Acquire and maintain current awareness of current state-of-the-art manufacturing approaches in cell and gene therapy
- Perform other duties, as assigned
- Bachelor or Master’s Degree in Science/Engineering with 10+ years’ relevant manufacturing/development experience within the Pharmaceutical/Biotechnology industry
- Extensive experience of GMP operations and aseptic processing
- Deep and relevant knowledge of manufacturing processes and related unit operations
- Knowledge of regulatory filings and the drug development process
- Flexibility and ability to travel to fit manufacturing schedules
- Ability to work in a matrix environment
- Experience of setting up and maintaining Statistical Process Control models for systems with highly variable inputs
- Ability to establish network of key contacts within industry to ensure current and future compliance with expectations from regulators and other interested parties
- Experience managing outsourced process development, testing, and manufacturing projects
- Ability to share and apply knowledge in support of technical challenges
- Strong technical networker
- Excellent interpersonal/communication skills and team player
- Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demand
- Communication and Teamwork – The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
- Customer Focus – The desire to understand and anticipate internal/external customer needs and take action to meet or exceed these needs.
- Effective Planning - Embedding discipline and thoroughness in our approaches.
- Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
- Results Oriented – Drives issues to closure and gets the job done.
Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.