AI Software Engineering Clinical Systems
Posted Updated
Description
CSBio and Yowei Therapeutics work closely to build peptide-manufacturing, clinical, laboratory, data, and operating capabilities. CSBio brings more than three decades of peptide and cGMP manufacturing experience, while Yowei Therapeutics is developing clinical programs in peptide therapeutics.
CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, CSBio passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA.
CSBio and Yowei Therapeutics are seeking a hands-on AI Software Engineer to build internal applications, AI-assisted workflows, data systems, and secure automations supporting clinical, laboratory, manufacturing, and company operations.
Job Duties:
- Design, build, test, deploy, and maintain internal web applications, dashboards, data tools, and workflow systems supporting CSBio and Yowei Therapeutics.
- Develop and improve internal systems used for employee, project, operational, clinical, laboratory, or manufacturing workflows.
- Build AI-assisted features using approved models and services, including document processing, structured extraction, search, retrieval-augmented generation, summarization, classification, and agent-assisted workflows.
- Create evaluation datasets, test cases, guardrails, logging, and human-review workflows to measure AI quality, reliability, security, and failure modes before release.
- Build responsive user interfaces and reliable backend services using technologies such as TypeScript or JavaScript, React or Next.js, Python, SQL, PostgreSQL or Supabase, and REST or event-driven APIs.
- Design database schemas, permissions, role-based access, authentication, audit logging, backups, and secure data flows appropriate to each application.
- Integrate approved internal and external systems, including laboratory, specimen, device, pharmacy, participant, project-management, and collaboration platforms.
- Translate operational problems and user feedback into clear requirements, technical designs, staged releases, and maintainable software rather than one-off prototypes.
- Write automated tests, perform code reviews, manage source control, document defects, and establish practical development, release, rollback, and incident-response procedures.
- Monitor deployed applications, investigate performance or reliability issues, correct defects, and communicate risks and outages clearly to users and leadership.
- Create technical documentation, architecture diagrams, data dictionaries, user guides, setup instructions, and training materials.
- Provide technical guidance, code review, and structured assignments to interns or junior developers while escalating architecture, security, privacy, and regulated-system decisions when needed.
- Evaluate software vendors, AI tools, and technical proposals; document security, data-use, integration, portability, and vendor-exit considerations before adoption.
- Protect company-confidential, participant, clinical, genomic, CMC, manufacturing, and QC information and follow approved data-classification, access, and retention requirements.
Clinical and Regulated Systems Responsibilities:
- Build or configure fit-for-purpose study databases, eCRFs, visit workflows, operational trackers, and clinical dashboards when assigned.
- Implement approved fields, validation rules, edit checks, controlled terminology, role-based access, audit trails, exports, and user workflows based on requirements supplied or approved by qualified clinical and data owners.
- Support testing, user-acceptance testing, defect correction, controlled releases, integrations, data transfers, and sponsor-controlled exports.
- Support clinical and laboratory system integrations without independently making protocol, medical, safety, statistical, regulatory, privacy, or Quality decisions.
- Maintain technical records supporting access control, version history, change management, validation evidence, backups, recovery, and vendor exit as required for the system.
Requirements
- Bachelor’s degree in computer science, software engineering, data science, information systems, engineering, or a related field, or equivalent demonstrated professional experience.
- 3+ years of experience building, deploying, and maintaining production software applications, internal platforms, data products, or comparable business-critical systems.
- Strong working proficiency with TypeScript or JavaScript, Python, SQL, and modern web-development practices.
- Experience with React, Next.js, or a comparable frontend framework and with PostgreSQL, Supabase, or another relational database platform.
- Experience designing and integrating APIs, authentication, authorization, role-based permissions, data models, and secure application workflows.
- Hands-on experience integrating LLM APIs or approved AI models into working applications, with practical attention to testing, evaluation, failure handling, privacy, and human review.
- Experience with Git or GitHub, code review, automated testing, debugging, documentation, deployment, and production support.
- Ability to independently convert loosely defined operational needs into clear requirements and working software while communicating tradeoffs and risks to non-technical teams.
Preferred Qualifications:
- Experience with retrieval-augmented generation, embeddings, vector search, structured outputs, document extraction, agent workflows, model evaluation, or AI observability.
- Experience with Vercel, cloud infrastructure, CI/CD, background jobs, queues, monitoring, logging, secrets management, or infrastructure-as-code.
- Experience building internal tools for biotechnology, pharmaceutical manufacturing, laboratories, clinical research, healthcare, or another regulated environment.
- Familiarity with EDC, eCRFs, CTMS, eSource, LIMS, REDCap, laboratory-data systems, or clinical-data integrations.
- Knowledge of GCP, 21 CFR Part 11, audit trails, computer-system validation, data integrity, privacy, or regulated change-control practices.
- Experience mentoring interns or junior developers and establishing practical engineering standards for a small team.
Benefits
- Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
- Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
- Disability insurance 50% standard employer paid.
- 401k 10% 1:1 match
- PTO policy. 10 days PTO
- Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
- Carpool, clean air vehicle, and cell phone reimbursement
- Employee rewards and recognition program
- Company organized social events
- Quarterly sponsored team building activities
Skills
As published by workable · 18 questions · 1 written answer
Basics
First name, Last name, Email, Phone, Address, Resume
Short answers (2)
- What is your annual salary expectation?
- How soon could you start working with us if you are hired?
Pick from a list (15)
- Are you able to work Saturdays or Sundays?
- Have you ever worked for this company?
- Do you have any friends or family working for this company?
- Are you at least 18 years old?
- Are you legally eligible to work in the United States?
- Will you now and in the future be able to work in the United States WITHOUT visa sponsorship? (Note: Answer "yes" if you will NOT need visa sponsorship, answer "no" if you WILL need sponsorship.)
- Are you able to perform the essential functions of the job for which you are applying, either with or without reasonable accommodation? (Note: We comply with the ADA and consider reasonable accommodation measures that may be necessary for eligible applicants/employees to perform essential functions. Hire may be subject to passing a medical examination, and to skill and agility tests.)
- Are you currently employeed?
- May we contact your current and/or previous employer(s)? (Note: Please be prepared to provide a list of current references upon request.)
- I hereby certify that I have not knowingly withheld any information that might adversely affect my chances for employment and that the answers given by me are true and correct to the best of my knowledge. I further certify that I have personally completed this application. I understand that any omission or misstatement of material fact on this application or on any document used to secure employment shall be grounds for rejection of this application or for immediate discharge if I am employed, regardless of the time elapsed before discovery.
- I hereby authorize CSBio to thoroughly investigate any references, work record, education and other matters related to my suitability for employment and further authorize my references to disclose to the company any and all letters, reports, and other information related to my work records without giving me prior notice of such disclosure. In addition, I hereby release the Company, my former employers and all other persons, corporations, partnerships and associations from any and all claims, demands or liabilities arising out of or in any way related to such investigation or disclosure.
- I understand that should a search of public records (including records documenting an arrest, indictment, conviction, civil judicial action, tax lien, or outstanding judgment) be conducted by internal personnel employed by the company, I am entitled to copies of any such public records obtained by the company unless I indicate "no" below. If I am not hired as a result of such information, I am entitled to a copy of any such records even though I indicate "no" below.
- I waive receipt of a copy of any public record described in the paragraph above.
- I understand that CSBio participates in E-Verify. This company will provide the Social Security Administration (SSA) and, if necessary, the Department of Homeland Security (DHS) with information from each new employee's Form I-9 to confirm work authorization. (Note: If the Government cannot confirm that you are authorized to work, CSBio is required to give you written instructions and an opportunity to contact DHS and/or the SSA before taking adverse action against you, including terminating your employment.)
- I certify that my answers are true and complete to the best of my knowledge. If this application leads to my employment, I understand that false or misleading information may result in my release.
Written answers (1)
- What specific experience, training, qualifications, or skills do you have that make you feel especially suited for work with this company?
