Director of Fermentation Process Development and Scale-Up

Director of Fermentation Process Development and Scale-Up Who We Are: Antheia is a science and technology company developing next generation plant-inspired medicines. Applying synthetic biology, genomics, bioinformatics, data science, and fermentation, we harness the most beneficial molecules from plants to create active pharmaceutical ingredients in more controlled and economical ways. We are a close-knit team inspired by the possibilities of delivering transformative technologies and breakthrough science to change the course of medicine. We value our people as our most important resource and are always looking for talented individuals who can make valuable contributions to our efforts. Job Description: Antheia seeks an experienced Scientist / Engineer to help lead the fermentation scale-up and tech transfer activities at Antheia. A successful candidate will be a strong communicator, effective problem solver, and able to work efficiently in a fast-paced, dynamic environment characteristic of a start-up. The candidate will be capable of working collaboratively with the R&D teams to ensure the processes developed can be cost-effectively scaled to commercial manufacturing level, and effectively communicating realistic timelines and cost considerations. Primary Process Development responsibilities extend to pilot scale planning and execution, tech transfer and scale-up activities, process qualification, deviation management, process monitoring, and post-approval change management to ensure production delivers an uninterrupted and timely supply of commercial products across Antheia's portfolio, meeting all process and product quality requirements. The selected candidate could also be significantly involved in helping develop scale-up and scale-down models for data interpretation and supporting material generation in support of DSP process development work. Responsibilities: Leads the tech transfer and scale-up of Antheia fermentation processes to commercial scale. Oversee and manage successful operations for pilot and commercial scale runs at external partners in support of product development / launch. Defines and manage timelines for fermentation tech transfer to outsourced manufacturing partners. Develop TEA models to support cost models for business decisions impacted by engineering changes such as manufacturing scale and process improvements. Assists in process-equipment gap assessments, as well as capital project management necessary for manufacturing tech transfer to external partners. Assist in design of Antheia pilot manufacturing facility as well as potential commercial manufacturing projects. Partners with Quality to manage and execute investigation of quality event investigations related to fermentation and the implementation of corrective and preventative actions. Establish and lead failure mode and effect analysis (FMEA) processes/templates. Develop and utilize scale-down models to predict and troubleshoot large-scale fermentation issues. Oversee and ensure the robustness and capability of manufacturing processes and quality of final products. Work with manufacturing, quality, and technical staff at Antheia and partner CMOs to prepare and review necessary technical documentation. Serve as Antheia's internal expert on fermentation scale-up and transfer. Implement continuous improvement initiatives. Travel required: up to 15-25%. Qualifications/Experience: 8-10 years of experience in a manufacturing fermentation operations environment. Experience with large scale fermentation (>50m 3) and tech transfer to Contract Manufacturers. Experience working with other manufacturing functions preferred. Exceptional organizational skills with the ability to attain deadlines and prioritize work on multiple projects. Experience managing internal and external stakeholders. Additional Information: Full-time base salary range of $185,000 - $210,000, plus an annual bonus potential and equity opportunities. Antheia’s compensation and benefits include: Comprehensive compensation package. Paid time off, in addition to company-observed holidays. Excellent medical, dental, and vision insurance. 401(k) retirement savings plan. Free access to the Menlo Park Labs Gym. Menlo Park Labs free shuttle service to CalTrain, BART Station, and SF. Antheia is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), or any other basis protected by law. Legal authorization to work in the United States is required. Apply for this job #J-18808-Ljbffr