Our Vaccine client located in Woburn, MA is growing and looking for a Director, Process Development & Formulations. This will be a hands-on role that will lead a team of engineers and scientists and collaborate closely with cross-functional teams to drive innovation to develop a platform technology.
The ideal candidate for this position is hands-on, and has a strong background in chemical engineering, process development and/or process engineering within a pharmaceutical or combination product environment, with an eye toward continuous improvement. This role offers a unique opportunity to take the company through initial clinical trials, a monumental step in bringing innovative technology to the global vaccine market, while also leading long-term platform strategy.
? Develop and test models for assessing the impact of critical formulation parameters on microneedle printing and drying.
? Create a framework to develop microneedle formulations, establish formulation production processes and scale up from early-stage R&D through pilot production.
? Develop test methods, specifications, protocol & report writing, in support of continuous improvement of the platform.
? Communicate highly complex ideas and projects to internal executive team, board, and external stakeholders.
? Manage, train, supervise, and mentor team members.
? BS in Chemical Engineering, Bioengineering/bioprocess, or related field with 10+ years OR MS/MA with 8+ years OR PhD with 4+ years of aforementioned experience
? Excellent communication and organizational skills
? Understanding of material & test specs generation, protocol & report writing, process & test development, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
? Experience in the development of regulated medical devices, pharma, or combination products is strongly preferred.
? Solid understanding of fluid mechanics. Experience in drying of complex formulations is highly desired.
? Experience setting up, executing, and analyzing results from designed experiments.
? Background in biologics (protein, mRNA, vaccine) early-stage process development would be helpful.
? Collaborative problem solving, risk assessment, and risk management skills.
? Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams.
***Must be eligible to work for any U.S. employer for an indefinite amount of time and commutable to the Woburn site.