Implementation Manager GxP jobs in United States
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Benchling · 3 weeks ago

Implementation Manager GxP

Benchling is a biotechnology company focused on unlocking the power of biotechnology through their R&D Cloud. They are seeking an Implementation Manager with expertise in systems validation and customer-facing implementation skills to support GxP customers in the pharmaceutical and biotech industries, guiding them through the implementation of the Benchling platform.

BiotechnologyLife ScienceSoftware
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

Computer Systems Validation (CSV)GxP ComplianceProject Management21 CFR Part 11Validation DeliverablesCuriousCreativeCommunication SkillsSelf-starter

Required

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

Preferred

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

Benefits

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

Company

Benchling

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Benchling is an IT company that provides a cloud-based software platform for biology researchers and research and development organizations.

H1B Sponsorship

Benchling has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (24)
2023 (11)
2022 (18)
2021 (10)
2020 (5)

Funding

Current Stage
Late Stage
Total Funding
$411.9M
Key Investors
Sequoia Capital Global EquitiesAlkeon CapitalMenlo Ventures
2021-11-17Series F· $100M
2021-04-14Series E· $200M
2020-05-28Series D· $50M

Leadership Team

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Sam Wickramasekara
Founder & CEO
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Ashutosh Singhal
Co-Founder and President
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Company data provided by crunchbase