The key responsibilities of the associate director of downstream process development will be a lab focused role that will include full ownership of downstream platform development, downstream lab build out and infrastructure, and lab execution to support viral vector downstream process development. The candidate will execute experiments, analyze and present data at cross functional and process development team meetings, and train members of the team in downstream operations. The associate director will be responsible for technical leadership during internal and external technical transfers.
· Serve as a Subject Matter Expert (SME) for the development of robust, high performing downstream processes with emphasis on transferability to cGMP manufacturing and supports regulatory filings.
· Develop robust, scalable, transferable processes for downstream production of rAAV clinical gene therapy vectors.
· Demonstrate innovative design, development, and execution of process development projects through literature review and scientific teamwork.
· Responsible for chromatographic and physical separations (TFF) development and bulk drug substance development operations.
· Manage all subject matter experts (SMEs) for internal projects in all areas of downstream process development.
· Execute the design, development, scale-up, and technology transfer, of gene therapy manufacturing processes.
· Direct process and method optimization and development of manufacturing platform across multiple products
· Assist in batch record review, deviation assessment, batch disposition.
· Write study development reports, process characterization reports, and transfer documents
· Assist in the generation of project and cost proposals, timelines, and work plans by applying scientific knowledge and project management experience.
· Author manuscripts and presents results at scientific meetings.
· A PhD in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant discipline and a minimum of 8 years of progressively responsible experience in gene therapy/vaccines/complex biologics process development roles.
· Experience with rAAV Gene Therapy products is preferred; experience with plasmid process development is a plus
· Proven leadership experience and people management skills
· Knowledge and experience with process characterization and transfer is essential. Expertise in DOE and statistical analysis of data is a plus.
· Strong organizational, analytical, and problem-solving skills.
· Work planning, data analysis and record keeping skills (with strong attention to detail) will be required.
· Ability to work in a fast-paced, start-up environment
· Strong collaboration and team building, communication, and organizational skills required
· Experience working with and managing third party contractors and vendors
· Excellent written and verbal communication skills
Spirovant is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.