Job Description
Location: Woburn, MA
Vaxess is an NIH and venture-funded company developing a pipeline of next-generation therapeutics on the Microneedle Array Patch (MAP) platform. With only five minutes of wear-time on the skin, the self-applied MAP enables sustained delivery in the skin. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
Manufacturing at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated Formulation engineer with a proven track record in leading Process Development, Tech Transfer as well as manufacturing support. The Formulation Engineer will report to the Director of Process Development and will collaborate closely with cross-functional teams such as Manufacturing, Assay Development, Quality Control, Automation, and Facilities.
Responsibilities
- Leads and supervises cGMP formulation operations related to Microarray Patch manufacturing, ensuring adherence to batch records, SOPs, and regulatory requirements. Provides hands-on guidance and oversight to junior staff and technicians during manufacturing campaigns.
- Oversees day-to-day manufacturing floor activities during formulation operations, ensuring safety, compliance, and productivity. Coordinates scheduling, resource allocation, and troubleshooting in collaboration with Manufacturing and Facilities teams.
- Trains, mentors, and evaluates manufacturing personnel involved in formulation processes. Develops and implements training materials and competency assessments to ensure operational excellence and compliance.
- Reviews and verifies documentation for completeness and compliance with regulatory standards. Ensures the timely completion of production batch records, logbooks, test records, and other documentation following Good Documentation Practices.
- Collaborates on process development and optimization studies for Microarray Patch formulations. Works as part of the process development team to optimize excipients and formulations to support project objectives. Maintains detailed experimental records. Documents data in reports and write detailed protocols.
- Collaborates closely with cross-functional team members of Manufacturing, Quality, Research, and Automation functions to support process development, manufacturing, and tech transfer between R&D and product development activities. Acts as a liaison between Research and Manufacturing teams to scale up formulation processes from R&D to production.
- Identifies and implements new technologies and assays to support continuous improvement and scale up of processes.
- Leads root cause analyses (RCA) and process development investigations.
- Authors, edits, and reviews batch records, SOPs, work instructions, and other documentation to support manufacturing readiness and regulatory submissions.
- Regularly communicates progress, issues, and results to key stakeholders.
Qualifications
- BS or MS in Biological Sciences, Chemistry, Biomedical Engineering, Chemical Engineering or a related discipline, with at least 3 years of relevant experience. Title will be adjusted commensurate with qualifications.
- Strong prior hands-on formulation process development experience. Demonstrated ability to design, execute studies, and analyze experimental results.
- Prior supervisory experience in a GxP environment is preferred.
- Strong understanding of Good documentation practices. Experience in authoring and reviewing batch records, SOPs, and work instructions.
- Strong verbal and written communication skills. Excellent time and project management skills.
- Demonstrated ability to learn new skills, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams.
- Strong attention to detail. Ability to identify root causes of problems and recommend corrective actions for continuous process improvement.