CSBio is a peptide manufacturing company in Menlo Park undergoing a major digital transformation. We are building a centralized data infrastructure that will digitize over 200 paper-based SOPs, batch records, test forms, certificates of analysis, and lab notebooks into structured, searchable, and auditable digital formats.
The AI & Digitization Specialist is a hands-on role with a steep learning curve and real ownership from day one. You will be one of the key executors of this transformation: converting paper processes into digital workflows, building AI automation tools using Claude, configuring the data platform, and training CSBio staff on new digital systems.
This is a ground-floor opportunity to build something that will fundamentally change how a GMP pharmaceutical manufacturing operation runs. You will touch every department — QC, QA, Production, Upstream, Downstream, Regulatory — and your work will directly impact compliance, efficiency, and data integrity across the company.
Key Responsibilities:
SOP & Document Digitization (40–50% of time)
• Convert 200+ documents into structured digital formats within the data platform
• Create reusable templates for batch records with auto-populated fields, electronic signature workflows, and real-time data capture
• Digitize QC test forms, stability study forms, Certificates of Analysis, and lab notebooks with built-in validation rules
• Ensure all digitized documents meet GMP compliance and audit-readiness standards
Data Platform Configuration (20–25% of time)
• Set up and configure the data platform infrastructure under architectural direction
• Build data models, user permissions, integrations, and workflow automations
• Design data entry interfaces that minimize errors and enforce data integrity
• Develop dashboards and reporting views for department leads
AI & Automation Development (15–20% of time)
• Build Claude automation skills for CSBio operations — you’ll be trained on how to do this
• Develop and iterate on AI-powered workflows that reduce manual effort across departments
• Assist with infrastructure setup for on-premise AI agent deployment
• Test, document, and maintain all automation skills and workflows
Staff Training & Change Management (10–15% of time)
• Train CSBio staff across all departments on new digital systems and workflows
• Create training documentation, quick-reference guides, and SOPs for digital tools
• Manage the transition from paper to digital — handle resistance, gather feedback, iterate on usability
• Provide ongoing support as departments adopt new systems
Qualifications:
Required
• Currently pursuing or recently completed a Master’s degree in a relevant field (life sciences, bioengineering, data science, health informatics, bioinformatics, computer science, or similar)
• Comfortable working with data in structured formats — you use Excel confidently and have some exposure to databases, SQL, or data tools through coursework or projects
• Quick learner with AI tools — you don’t need to be an expert, but you should be someone who experiments with ChatGPT, Claude, or similar tools and gets excited about what they can do
• Excellent attention to detail — this role touches GMP-regulated documents where accuracy matters
• Strong communication skills — you will train non-technical staff and need to make digital tools approachable and non-intimidating
• Self-directed and organized — you’ll manage a large-scale project across multiple departments with guidance but real autonomy
• Genuine interest in biotech, pharma, or healthcare — you don’t need deep industry experience, but you should care about the science behind what we do
Preferred:
• Coursework or research experience in pharmaceutical sciences, regulatory affairs, or GMP-regulated environments
• Exposure to FDA documentation (SOPs, batch records, IND submissions) through school or internships
• Any programming or scripting ability (Python, JavaScript, R, or similar) — even from a class project
• Experience with data visualization, dashboard tools, or document management systems
• Prior internship or project work involving process improvement, digitization, or systems implementation
What You’ll Learn:
This role is designed to give you broad, hands-on experience that a typical early-career position doesn’t offer. Within your first year, you will gain practical knowledge of:
• GMP pharmaceutical manufacturing operations — how peptides go from synthesis to clinical trial
• FDA regulatory documentation and compliance requirements for drug manufacturing
• Data platform architecture and implementation in a regulated environment
• AI/LLM tool development — building real automation workflows, not just using chatbots
• Change management — how to get an entire company to adopt new systems
• Cross-functional leadership — you’ll work with scientists, QC analysts, production staff, and executives
If you’re considering a career in biotech operations, digital health, data science in pharma, or eventually starting your own company in this space, this role gives you a front-row seat to how a real manufacturing operation works from the inside.
What Success Looks Like:
First 30 Days
• Complete onboarding: understand platform architecture, CSBio operations, and the full SOP inventory
• Audit existing documents and create a prioritized digitization roadmap
• Set up development environment and gain access to all systems
• Shadow key staff in QC, Production, and QA to understand how paper documents are used daily
First 90 Days
• Digitize first 30–50 SOPs and batch record templates into the platform
• Launch first set of digital workflows in at least one department
• Build and deploy 2–3 Claude automation skills
• Begin staff training sessions with early adopter departments
First 6 Months
• 100+ documents digitized with validated templates in active use
• Data platform configured and operational for daily use across multiple departments
• All core AI automations built and running
• Staff across CSBio trained and independently using digital systems
Why This Role Matters:
CSBio is at an inflection point. We manufacture peptides for clinical trials and commercial use. As we scale, our paper-based systems are becoming a bottleneck for compliance, efficiency, and data-driven decision making.
This role is the engine of our digital transformation. The platform you build and the systems you digitize will be used by every person in the company, every day. This is not a back-office IT role — it is a high-impact position at the center of the company’s growth.
How to Apply:
Send your resume and a brief note telling us about a time you improved, digitized, or automated a process — it can be from a class project, a research lab, an internship, or even something you did on your own. What was the problem, what did you build or change, and what happened?
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