Job Description
Guiding customers through Benchling platform implementations in regulated environments ensures biotech projects advance compliantly, transforming workflows for scientists and quality teams. This role bridges validation expertise with project management, helping clients from startups to biopharmas validate systems under 21 CFR Part 11, reducing time to market and mitigating regulatory risks.
Benchling develops an R&D Cloud for innovative biotech companies, empowering development of breakthrough products like medicines and crops through modern software integrated with AI and global APIs.
Duties encompass managing rollouts from requirements analysis to testing and training, acting as a subject matter expert on GxP validation, advising on risk-based approaches and deliverables like validation plans and protocols, leveraging product knowledge for business needs within scientific processes, leading workshops for data modeling and user acceptance, collaborating with teams for feedback-driven improvements, identifying expansion opportunities post-launch, and adhering to strict travel requirements up to 25% for hands-on support.
Salary ranges from $118,000 to $183,000 depending on location zone. Work involves up to 25% travel as needed, with four weeks PTO, medical, dental, vision coverage, 401(k) match, parental leave, commuter benefits, mental health support, wellness stipends, learning opportunities, sabbaticals, and company-wide shutdowns.
Responsibilities
- Manage initial rollouts for new customers and expansion projects at existing ones, with focus on GxP and regulated environments
- Own implementation success from kickoff to go-live
- Build and execute detailed project plans, collaborate with team members
- Serve as GxP subject matter expert during implementations
- Guide customers through CSV activities, understanding validation within quality systems
- Understand customers' scientific workflows and leverage Benchling for business needs while maintaining regulatory compliance
- Lead requirements and design workshops, perform data modeling and application configuration, develop test plans and guide UAT execution, train and onboard users
- Act as trusted advisor, guiding through implementation ensuring compliance
- Collaborate with internal teams on feedback to influence product development
- Identify and work with sales on opportunities for account expansion post go-live
Requirements
- Bachelor's in engineering, life sciences, or related field
- 3-5 years hands-on CSV experience in pharmaceutical, biotech, or regulated environments
- 2+ years at pharmaceutical company, biotech, or similar
- Strong understanding of 21 CFR Part 11, Annex 11, GAMP 5, and CSV principles in GxP environments
- Experience creating or reviewing validation deliverables such as Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports
- Demonstrated application of risk-based validation approaches
- Strong communication skills to connect with scientists, quality, IT, and executives
- Strong project management for multiple workstreams
- Self-starter in fast-paced environment
- Curious, creative, tenacious
- Ability to travel up to 25%