Associate Director, Drug Product, Process Development

2 weeks ago

Watertown, United States Tome Biosciences Full time

At Tome, we are developing the next generation of programmable genomic integration technology. Our technologies allow us to insert any genetic sequence of any size at any location into any genome. We are building an exceptional team and a work environment that is diverse, innovative, rewarding, and fun. We have an opportunity to re-write the patient story, and together, we are writing a new chapter in genomic medicines.

Reporting to our Senior Director, Drug Product, Process Development, we are seeking an Associate Director to join our team. This position is predominantly a lab-based role and will be responsible for developing scalable processes for LNP delivery of gene-editing RNA cargos. This position will play a critical role in successfully developing manufacturing processes that deliver a quality LNP drug product.

Key Responsibilities:

* Define and lead the execution of a development plan for LNP drug product.
* Employ engineering principles and design of experiments (DOE) to define process parameters, and control strategies for robust, scalable, and efficient manufacturing of LNP drug product.
* To mentor and develop Research Associates and Scientists working on the development team.
* Identify areas for process innovation and efficiencies and execute against those action plans.
* Support internal production for IND-enabling studies and lead process tech transfer to internal and/or external manufacturing teams.
* Contribute to process development reports, IND enabling regulatory documents etc.

Qualifications:

* Ph.D. in Chemical/Biomedical Engineering, Biochemistry, or a related discipline with 8+ years relevant industrial experience or M.S. with 10+ or B.S. with 12+ years.
* Technical hands-on experience in process development of LNPs (mixing technologies, normal, tangential flow and, sterile filtrations).
* Experience with statistical methods and software for the design and analysis of experiments (e.g.; JMP).
* Working knowledge of LNP process analytics.
* Experience in mentoring Research Associates and Scientists working in development team.
* Experience in tech transfer and manufacturing of LNPs at internal/external sites.
* Excellent interpersonal and communication skills (both verbal and written).
* Demonstrated ability to be self-motivated, proactive, and capable of generating results in a fast-paced cross-functional environment.

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