
Lab Automation Lead (Manager)
- Göteborg
- Permanent
- Heltid
- Independently performs program optimization and validation of complex scripts. Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and executes experiments independently.
- Reviews and critiques automated instrumentation programs and associated documentation and other related technical documents.
- Communicates data, technical issues, information regarding project definitions and expectations, and discussions of project status to stakeholders as needed
- Provides technical guidance
- Leads analytical (procedural and instrumentation-related) troubleshooting sessions
- Assists in preparation and implementation of SOPs and quality systems.
- Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices
- (GMP) or Good Laboratory Practices (GLP).
- Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
- Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical application.
- Communicates status of project efforts to manager.
- Provides leadership and mentoring to team members in order to improve their technical expertise and scientific knowledge.
- Implements novel approaches to method development and applications as appropriate.
- Provides training/orientation to production staff as needed to successfully implement methods. Assists in startup and troubleshooting methods through the first analytical application and as needed in future projects.
- Complex remedial maintenance (e.g., complex hardware replacements)
- Performs programming and/or process mapping for fully automated workflows
- Implements data integrity processes; supports instrument software validation efforts
- Provides team coaching/mentorship
- Organizes, schedules and supervises laboratory automation resources for group's project activities
- Direct experience with automation instrumentation required; vendor service certification preferred
- Experience with programming (Hamilton Venus, TECAN EVOware or Fluent Control, Thermo Momentum, VB, Python, etc.) required; vendor programming certification (or equivalent) preferred
- Ability to operate and troubleshoot a wide variety of analytical instrumentation and data acquisition systems
- Ability to manage multiple tasks and priorities
- Proven project management skills
- Proven ability to work in a collaborative work environment with a team
- Proven understanding of GxP requirements, SOPs, ICH guidelines, USP requirements and FDA
- Proven troubelshooting and critical thinking skills; ability to independently perform root cause analysis for method investigations
- Proficient in complex automated platform software use and programming and/or hardware troublshooting/replacement
- Proven ability to train or provide mentorship to other automation staff for programming, system optimization, validation/qualification requirements, etc.
- Knowledge of data generation and statistical programs
- Knowledge of general chemistry, separation science, immunochemistry, molecular genomics, biomarker, and/or vaccine science related concepts and/or technologies (as applicable)
- Proven technical writing skills
- Proven effective communication (written and oral) and organizational skills
- Proven leadership skills
- Demonstrated ability to be project-solution driven
- Ability to write and recommend changes to SOPs