Mogrify is a cell therapy development company. We have developed a systematic big data-science approach (Rackham et al., Nature Genetics, 2016) powered by next-generation sequencing and gene-regulatory data to identify the optimal combination of transcription factors (in vitro) or small molecules (in vivo) for direct cell programming. This allows the conversion of any mature cell type into any other mature cell type without traversing a pluripotent stem cell- or progenitor cell-state. We are applying this approach to address the issues of efficacy, safety and scalability currently associated with cell therapy development.
We are looking for an experienced and motivated Director of Development who is seeking to join a fast-paced environment and enjoy the challenges of being in a new start-up. The Director of Development will play a pivotal role in the translation of early stage research into industrial manufacture of clinical products.
At Mogrify, your responsibilities include:
• Oversee the translation of research-based methods to scalable and robust clinical manufacturing protocols
• Responsible for successful development, characterization and tech transfer to state-of-the-art manufacturing processes for cell culture production/characterization under good manufacturing practice (GMP)
• Technical leader who applies scientific and technical expertise and business acumen to establish strategies, drive safe and efficient lab work, and deliver robust, high-quality, and high-yield manufacturing processes
• Develop creative and pragmatic solutions to technical and operational challenges
• Prepare study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials
• Provide strong technical and strategic leadership and make significant contributions to cross-functional project teams to ensure efficient and timely execution of the team’s deliverables
• Remain up-do-date with developments in cell technologies to identify best practice
• Contribute to regulatory submissions (IND and CTA) and query responses; present data/ strategy to peers and management in appropriate internal and external venues (technical meetings, project team meetings, conferences); authors technical reports, patent applications, and publications in peer-reviewed journals, as appropriate
• Establish and drive relevant and impactful innovation programs that are aligned with business drivers and regulatory paradigms to enhance upstream manufacturing technologies and work processes
• Demonstrate independence, strategic thinking and the ability to rapidly learn and apply new concepts
• Demonstrate positive leadership qualities, mentor junior scientists, and foster a collaborative team environment; model desired values and behaviors, including quality, integrity, respect, and personal accountability
• A degree and equivalent combination of training and experience in molecular and cell biology, biochemistry or life sciences
• 5-10 years’ experience working in a similar function; understanding of cell therapies and the regulatory landscape is preferred
• Previous exposure to GMP manufacturing of cell therapy or biological products, or participation in technical transfer of clinical processes to a CMO, or tech transfer of product release & characterization or clinical assays to a CRO, or other third party is a plus
• Experience in developing cell therapy or biological products manufacturing processes, or experience in developing and executing cellular characterization assays, including flow cytometry-based
• In-depth experience in principles and practices of cell biology methodologies, cellular immunology or stem cell biology (e.g., induced pluripotent stem cells (iPSCs)), including cell culture, cell transfection and transduction, development and execution of functional in vitro and preclinical methods relevant for various types of immune cells or stem cells
• Understanding of viral transduction principles and processes is strongly preferred
• Experience in pluripotent stem cell expansion, differentiation and associated product quality analysis
• Experience in cellular characterization assays, including flow-cytometry-based, qPCR, ELISA and other cellular assays
• Accurate with a strong focus and attention to detail
• Proven ability to engage constructively with colleagues internally at all levels across different departments as well as externally
• Strong analytical and problem-solving skills; proficient in statistical experimental design and analysis of complex multi-variate processes
• Experience managing and developing direct reports (or contract staff) is preferred
• Demonstrated ability to drive for results and lead innovation and change
• Applicants should be highly organized, self-motivated, and capable of working both independently and collaboratively; adept at working in a fast-paced team environment with shifting priorities
Benefits of working with Mogrify:
We offer a competitive salary and stock incentives along with a highly competitive benefits package including a pension contribution scheme as well as health, dental and life insurance.
This is a great opportunity to join a fast-growing biotech company. If you would like to apply for this position, please send your CV with a covering letter to firstname.lastname@example.org clearly stating the role you are applying for.