Who You Are

You are a highly motivated individual with a vision for pioneering innovations in probiotics and living medicines to impact human and planetary health. You are an organized, self-motivated, hands-on, natural leader who excels in impeccably managed CMC/manufacturing workflows with the ability to thrive and execute in a remote-based work environment. 

With a proven track record in US and EU cGMP regulations and intimate knowledge of microbiological early stage CMC development, you are excited at the prospect of rolling up your sleeves to optimize Seed’s CMC operations. While possessing a robust technical background in biome/LBP products and applicable regulations, you are not afraid to think outside the confines of traditional approaches to provide creative solutions for early-phase clinical programs. You will report to our Chief Scientific Officer to manage CDMO partnerships, oversee all steps to early-stage clinical trial manufacturing, as well as scale-up and process development across both our consumer and therapeutic programs. You possess the experience to confidently tee up and drive high-level strategic discussions to a resolution and can provide guidance regarding the nuances of your métier to any member of the company. 

Holding stakeholders accountable is second nature to you, as you seamlessly navigate a matrix team of internal experts and external vendors to deliver against aggressive timelines. You manage documentation and protocol review, SOP implementation, manufacturing timelines, and infrastructure development with ease. At all times you have your finger on the pulse of what’s happening with our external vendors. You review, resolve, and regulate optimization plans, protocols, stability documentation, method development, bench-top experiments, SOPs and SOWs. 

As a key hands-on team player, you approach challenges with a can-do attitude, possess a keen eye for detail, but are also skilled in strategizing at a big-picture level for the company’s desired program. You ensure project coordination of research, development, production, testing, and optimization activities, while achieving a balance of strategic vision, urgency, and judgment. You execute tactically, anticipating any technical or functional issues before they arise. Not only do you promote, but you embody a culture of synergistic collaboration, operational excellence, and cross-functional problem-solving.

What You’ll Do

• Collaborate with key stakeholders to establish strategic manufacturing plans and deploy scale-up and manufacturing projects 
• Provide management oversight to enable successful program execution and ensure alignment across R+D, Quality, and Product Development, and Go-To-Market team members
• Oversee execution of manufacturing and testing activities and timelines at CDMO’s and CTL’s (e.g., new product introduction, tech transfer, process development/characterization, assay qualification/validation, production, testing, product disposition by QA, etc.) 
• Effectively manage vendor meetings, driving against prepared agendas and enforcing timelines for action items from external stakeholders
• Responsible for daily CMC program decision making and facilitating escalation of larger strategic matters to CSO and leadership
• Manage internal product document/data repository
• Implement robust project management, communication, and KPI tracking tools
• Generate demand forecasts and ensure on-time production to meet clinical and program needs
• Create and adhere to program and project budgets
• Partner with subject matter experts to support CMC requirements and timelines for regulatory filings
• Collaborate closely with internal stakeholders, including Research, Clinical Supply, Regulatory, and Quality, to align on overall product development and regulatory strategy
• Routinely review stability documentation, protocols, statements of work, batch records, as well as request of appropriate documentation from CDMO 

Qualifications

• BS in a scientific discipline with ≥10 years relevant industry experience
• 5-7+ years leading CMC programs
• Strong risk management analysis and project management skills (CAPM, PMP, or similar certification preferred but not required) 
• Strong cGMP acumen and knowledge of manufacturing/quality requirements for early-stage CMC product development 
• Previous experience in filing IND/Regulatory submissions preferred 
• Prior experience in biologics/pharmaceutical manufacturing, supply chain, and/or CDMO management
• Understanding of live-biotherapeutics/probiotic product development 
• Impeccable time-management and multi-project planning and coordination
• Analytical background required 
• Experience using Microsoft projects, Google Suite, Excel, PowerPoint, Gantt charts, etc. 

The annual pay range for this full-time position is $160k-$190k + equity + benefits across all US locations (this position is 100% remote-US). Our pay ranges are guided by discipline, level and experience required. Within the range, individual pay may vary based on additional factors, including: your specific location, desired skills/ technical competency, relevant experience and advanced education/ training. Benefits include: Medical, Dental, Vision, Life, AD&D, LTD, Mental Wellness, EAP, Wellness Stipend + 401(k) match.