Independently design, develop and implement partial and integrated automation platforms for bio-analytical methods that are performed in GMP and non-GMP labs.
Effectively communicate experimental results to influence program decisions and support regulatory filing strategies.
Partner with external integration vendors to establish end-to-end integrated analytical automation platforms.
Collaborate with stakeholders to ensure automation designs and development meet the business goals and needs.
Support all functions related to automation technical transfer into GMP lab, including documentation associated with requirements gathering, development, IQ, OQ, and method validation.
Optimize automated systems, expand capabilities, and support technical investigations.
Lead automated method qualification and operator training activities.
Work with automation team members to support or maintain automated systems as needed.
Develop and maintain documentation related to automated analytical methods and technologies.
Provide technical support to end-users and stakeholders.
Train and mentor other team members on automation technologies.
Collaborate effectively across functional groups. Work-life programs include paid national holidays and optional holidays,
Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities BS or MS in engineering discipline with 8+ years of integrated automation experience. Demonstrated experience as an automation developer in automated liquid handlers associated software (e.g. Hamilton and Venus software), end-to-end assay automation workflows, and integrated automation systems.
Proven track record in developing and implementing automated laboratory workflows and high-throughput methods within the biotechnology or pharmaceutical industry, including systems configuration, liquid handling, and method programming.
Experience designing, programming, operating, and troubleshooting end-to-end integrated automation systems including lab orchestration scheduler software (e.g. HighRes BioSolutions systems and Cellario platform).
Ability to identify/understand sophisticated customer needs and develop automated solutions for laboratory workflows.
Experience leading evaluation and implementation of new and novel technologies.
Experience migrating bench techniques to hands-free automated systems is required.
Excellent problem-solving skills.
Strong interpersonal skills with the ability to develop and maintain effective professional relations across all organizational levels in both GMP and non-GMP environment.
Flexibility and eagerness to learn new techniques and skills, with the ability to interface across multiple departments.
Possess a strong sense of urgency and ownership.
Experience with various programming languages, such as Python, Visual Basic, C, C++, etc. is preferred.
Experience in analytical method development is highly desirable.
Working knowledge of the regulatory requirements for bio-pharmaceutical industry and GMP compliance is preferred.
