Implementation Manager GxP

Biotechnology is rewriting life as we know it, from the medicines we take, to the crops we grow, the materials we wear, and the household goods that we rely on every day. But moving at the new speed of science requires better technology.

Benchling’s mission is to unlock the power of biotechnology. The world’s most innovative biotech companies use Benchling’s R&D Cloud to power the development of breakthrough products and accelerate time to milestone and market.

Come help us bring modern software to modern science.

ROLE OVERVIEW

Benchling is building a world-class Professional Services team to drive implementations for our rapidly expanding customer base. We're seeking an Implementation Manager with a unique blend of systems validation expertise and customer-facing implementation skills to support our growing portfolio of GxP customers in the pharmaceutical and biotech industries.

In this role, you'll leverage your project management, communication, and validation expertise to guide customers through both GxP and non-GxP implementations of the Benchling platform. You'll work hand-in-hand with research scientists, quality professionals, and IT teams at our customers, from small biotech startups to the largest biopharmas in the world, to develop a deep understanding of their R&D processes and roll out solutions that transform how their teams work together, while ensuring compliance with regulatory requirements.

Implementation Managers lead all aspects of customer rollouts from requirements analysis and solution design, to configuration, testing, training, and onboarding users onto the system. Your validation expertise will be critical in helping customers understand how to validate Benchling within their quality systems and regulatory frameworks.

RESPONSIBILITIES

• Manage initial rollouts for new Benchling customers as well as expansion projects with new teams or for new processes at existing customers, with particular focus on GxP and regulated environments.

• Own implementation success from project kickoff to go-live, leveraging strong project management skills, validation expertise, and deep product knowledge.

• Build and execute detailed project plans, own project activities, and work with other team members to execute on project deliverables to ensure on-time, on-budget, high-quality deployments.

• Serve as the GxP subject matter expert during GxP implementations, advising customers on validation strategy, risk-based approaches, and regulatory best practices for implementing Benchling within their quality systems.

• Guide customers through their computer systems validation (CSV) activities, helping them understand how to create validation deliverables (Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices, Validation Summary Reports) aligned with their internal procedures and regulatory requirements.

• Understand customers' scientific workflows and determine how Benchling can best be leveraged to meet their key business needs while maintaining compliance with relevant regulations (21 CFR Part 11, Annex 11, GxP).

• Lead requirements and design workshops, perform data modeling and application configuration, develop test plans and guide UAT execution, train and onboard users.

• Act as a trusted advisor for customers, guiding them through the implementation ensuring they leverage and apply Benchling best practices for both scientific workflows and regulatory compliance.

• Collaborate with internal teams to ensure customer feedback on validation processes and GxP requirements influences product development and validation package improvements.

• Identify and work with sales on opportunities for account expansion post go-live.

QUALIFICATIONS

• B.S. in engineering, life sciences, biological sciences, or a related field.

• 3-5 years of hands-on experience with computer systems validation (CSV) in pharmaceutical, biotech, or other regulated life sciences environments.

• 2+ years of experience working at a pharmaceutical company, biotech, or similar regulated organization.

• Strong understanding of 21 CFR Part 11, Annex 11, GAMP 5, and principles