Over the coming years, biotech will fundamentally rewrite the way we live. Gene editing and cell therapy are dramatically changing how we treat cancer and other major illnesses. Biofuels and biomaterials are transforming the cars we drive, the clothes we wear, and the makeup of everyday objects. Crop science and synthetic biology are producing sustainable and ethical food. Benchlings mission is to accelerate the research that propels us towards this reality, and magnify its impact, through modern software.
Every day, scientists around the world use Benchlings applications, platform, & analytics in their efforts to solve humanitys most pressing problems. For these scientists, Benchling is the central technology they use to conduct their research. Our customers include pharmaceutical giants, leading biotechs, and the worlds most renowned research institutes.
Benchling is rapidly expanding its product offerings to support pharmaceutical development & manufacturing, which in turn will drive greater revenue opportunities for the company. Supporting this, Benchling has established a validated offering for our customers in support of their high quality R&D and GxP compliance programs.
As a Head of Product Validation, you will drive the vision of being able to develop a validation program for the "new way of doing things" in the cloud via SaaS and in an agile development paradigm. You will partner with product and engineering teams in defining Benchlings validation scope and strategy. The right candidate would possess deep technical and business process understanding of lab systems used in GxP environments.
WHAT YOU WILL WORK ON
- Build and grow a team of high performing validation leads/engineers on validation projects of Benchlings products and internal business systems to ensure deliverables conform to company and regulatory requirements
- Establish validation processes that follow a risk-based approach and oversee the execution to ensure the scope, schedule, regulatory alignment with customer expectations
- Responsible for tracking, monitoring, and controlling validation process to ensure timely delivery to meet pre-scheduled release dates. Review and approve validation deliverables for Benchlings validated product releases
- Effectively work with cross-functional teams (Engineering, Product, Design, Security, Customer Experience) to ensure the validated state of the system is maintained
- Act as management interface between product, engineering, customer experience in regards to validation exigencies and approach
- Measure the impact of the validation work by defining success metrics, tracking progress, and iterating on plans based on that data. Continuously improve processes to maintain a best-in-class validated offering
WHO YOU ARE
- Have 10+ years of relevant experience in implementation and validation of enterprise SaaS software application used in the life sciences regulated environment (GLP, GCLP, GMP)
- Have strong knowledge of lab systems and processes (LIMS, LES, EBR etc.) along with a solid understanding of the regulatory requirements including FDA, EMEA, GAMP, ICH, etc. particularly as it applies to regulated software development
- Understanding of software development practices in an agile environment
- A manager, coach, and mentor that has a proven track record of recruiting and building strong validation teams
- A strong problem solver that can prioritize and drive execution
- Possess influential leadership and interpersonal skills that enable you to build strong relationships with customers, your reports, company peers, and senior executives
- Are excellent at listening to others and articulating ideas - verbal and written
- The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management
Benchling welcomes everyone. We believe every member of our team enriches our diversity and inclusion by broadening our ways of problem-solving for future challenges. Even if you don't meet 100% of the qualifications for this job, we strongly encourage you to apply.
- Admit mistakes and shortcomings
- Deliver results
- Disagree and commit
- Obsess over customers
- Rely on work ethic
- Show empathy
- Recruit and develop the best
- Sweat the details
- Think and communicate clearly
- Unite around the mission
PERKS AND BENEFITS
- Work with a talented yet humble team
- Competitive compensation & equity package
- Weekly virtual social events, and annual company retreats
- 401k, Medical, dental, and vision insurance (US Employees Only)
- Monthly health & wellness stipend (Currently US Employees Only)
- Yearly educational stipend (Currently US Employees Only)
- Flexible & Generous Vacation Policy: If you feel you need a break, you can talk directly with your manager to find coverage and support while you are out of the office. Need time off to vote? We've got you covered.
- Quarterly company-wide mental health days off
- Holiday Shut-down: company-wide holiday shut-down between Christmas Eve and New Years
- Major US and EMEA holidays observed
- To support remote work conditions during the COVID-19 pandemic, Benchling provides each employee a one-time stipend of $1,000(USD) upon commencing employment, and additional discounted employee purchase plans for home-office equipment.
In following best practices and safety protocols, all Benchling employees are expected to work remotely until we are further advised that it is safe for employees to resume work in their respective office locations.
We are an equal opportunity employer and value diversity at our company. We do not 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.