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.

Benchlings mission is to unlock the power of biotechnology. The worlds most innovative biotech companies use Benchlings 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. Were 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 youll leverage your project management communication and validation expertise to guide customers through both GxP and non-GxP implementations of the Benchling platform. Youll 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

Requirements

• 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 of computer systems validation 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 ability to apply risk-based validation approaches and advise on validation strategy.
• Strong communication skills with the ability to quickly and effectively connect with a range of stakeholders including scientists quality professionals IT project leads and executives.
• Strong project management skills with the ability to manage multiple workstreams and stakeholders simultaneously.
• Self-starter with the ability to be successful in a fast-paced environment.
• Curious creative and tenacious. You should be excited to collaborate with customers and other Benchling teammates as a thought partner.
• Ability to travel up to 25% based on customer and project needs.

Bonus if you have:

• Hands-on bench science or laboratory research experience in molecular biology biochemistry or related fields.
• Experience using Benchling or other R&D SaaS platforms especially as an administrator or power user.
• Software implementation or professional services experience preferably with a SaaS company.
• Knowledge of Agile software development methodologies and software testing practices.
• Experience with lab or manufacturing systems commonly used in life sciences (LIMS ELN MES QMS).
• Experience mentoring or training others on validation principles or implementation best practices.

HOW WE WORK

We offer a flexible hybrid work arrangement that prioritizes in-office collaboration. Employees are expected to be on-site 3 days per week (Monday Tuesday and Thursday).

SALARY RANGE

Benchling takes a market-based approach to pay and pay may vary depending on your location. The candidates starting pay will be determined based on job-related skills experience qualifications interview performance and work location.

ZONE 1: $139000 - $183000

ZONE 2: $125000 - $164000

ZONE 3: $118000 - $155000

To help you determine which zone applies to your location please see this resource. If you have questions regarding a specific locations zone designation please contact a recruiter for additional information.

Total Compensationincludes the following:

• Competitive salary and equity
• Broad range of medical dental and vision plans for employees and their dependents
• Fertility healthcare and family-forming benefits
• Four months of fully paid parental leave
• 401(k) Employer Match
• Commuter benefits for in-office employees and a generous home office set up stipend for remote employees
• Mental health benefits including therapy and coaching for employees and their dependents
• Monthly Wellness stipend
• Learning and development stipend
• Generous and flexible vacation
• Company-wide Winter holiday shutdown
• Sabbaticals for 5-year and 10-year anniversaries

#LI-Hybrid

#BI-Hybrid

#DNP

Benchling welcomes everyone.

We believe diversity enriches our team so we hire people with a wide range of identities backgrounds and experiences.

We are an equal opportunity employer. That means we dont discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status. We also consider for employment qualified applicants with arrest and conviction records consistent with applicable federal state and local law including but not limited to the San Francisco Fair Chance Ordinance.

Please be aware that Benchling will never request personal information payment or sensitive details outside of Greenhouse or via email. All official communications will come from an @ email address or from an approved vendor alias. If you are contacted by someone claiming to represent Benchling and are unsure of their legitimacy please reach out to us at to verify the communication.