Associate Staff Scientist - Laboratory Operations (CARAT)

Description

Position Summary

The Associate Staff Scientist - Laboratory Operations will play an essential role in supporting and advancing the laboratory operations of the Clinical and Regulatory Affairs Team (CARAT)/IVD Device Validation department. The department is responsible for global regulatory registrations and compliance with a substantial focus on performance evaluation and validation of molecular in vitro diagnostic products for infectious disease.

This position requires strong communication, organization, and time/task management skills in addition to technical expertise in microbiology and molecular biology laboratory practices and principles.

The Associate Staff Scientist - Laboratory Operations will work both independently and interactively/collaboratively with Research Associates, Scientists, and Director-level personnel and will play a role in training and supervising the work of Research Associates. May directly or indirectly manage Research Associates.

This is a full-time exempt on-site, laboratory-centric position.

Primary Duties

1. Perform all work in compliance with company policy and quality system procedures and standards.
2. Conduct oneself professionally and in accordance with company policies and Employment Handbook - act as an exemplary lab citizen and team-member.
3. Coordinate with R&D Laboratory Operations personnel and team members to maintain departmental lab operations, organization, safety, and cleanliness; may participate in the evaluation of lab design and layout for maximum safety and workflow efficiency.
4. Serve as departmental point-of-contact and/or point of responsibility in coordination with R&D Lab Operations personnel for oversight of daily departmental lab operations and equipment tracking and maintenance; including procurement, set-up, training, performance maintenance/calibration and obsolescence.
5. Oversee purchasing and maintenance of lab supplies and critical organism and nucleic acid inventories for department.
6. Serve as lab safety specialist for team and department representative at lab safety and operations meetings.
7. Demonstrate strong working knowledge and/or expertise in principles, tools, and techniques of microbiology, molecular biology, and infectious disease diagnostics.
8. Develop, revise, and train others on technical and operational protocols, procedures/SOPs, and Work Instructions Documents (WIDs). Monitor for compliance.
9. Ensure data integrity and accurate record-keeping in compliance with established SOPs, WIDs, and Study Protocols.
10. Establish and manage training programs (equipment, operational/procedural, and scientific topics) for onboarding and continuous learning and development of team members.
11. Lead and/or contribute to the establishment and implementation of short and long-term plans for systems and processes; including laboratory information and inventory management systems.
12. Support and assist multiple project teams with ongoing operational needs and scheduling as well as process evaluation, improvement, and execution.
13. Use data and critical thinking to evaluate successful performance and/or deficiencies in data, products, equipment, and experiments. Includes identification of patterns and trends, and critical review of results. Propose strategies and solutions for technical and operational issues and when deficiencies are identified.
14. Exercise good judgment and prioritization in time and task management, experimental design and execution, and presentation of results and outcomes to peers and leadership.
15. Be accountable for task completion and follow-through to maintain project goals and timelines. Balance competing tasks from multiple projects.
16. Attend and actively contribute to all assigned meetings, including company and group meetings.
17. Be curious, communicative, and committed to making ‘Cool Stuff’.
18. Perform other duties as assigned.

Supplemental Data

Please note this job description is not designed to cover or contain a comprehensive listing of all activities, duties, or responsibilities required of the employee for this job. 

This role supports multiple CARAT (Clinical and Regulatory Affairs) laboratory teams (approximately 50-70 people). The laboratory needs and procedures within the department are both shared and unique for the individual teams and also both shared and unique in relation to adjacent Research & Development teams.

Qualifications

Training and Education

• Master’s degree (relevant scientific field) with at lease 6 years of molecular biology/PCR laboratory experience.

OR

• Bachelor’s degree (relevant scientific field) with at least 8 years of postgraduate molecular biology/PCR laboratory experience.

Experience

• Masters: at least 6 years of molecular biology/PCR laboratory experience
• Bachelors: at least 8 years of post-graduation molecular biology/PCR laboratory experience
• Preferred: clinical or industry laboratory experience
• Preferred: at least 2 years of laboratory management and/or laboratory project management experience

Technical Skills

• Proficiency in MS Office and database management
• Proficiency/expertise in nucleic acid isolation and molecular/PCR technologies (RT-PCR, RT-qPCR, digital PCR, sequencing and sequence analysis)
• Experience with/proficiency in standard microbiological techniques (sterile technique, culture, enumeration, identification) for bacteria and/or yeasts.

Professional Skills

• Communication – verbal and written
• Building and maintaining effective partnerships - must work well with cross functional teams
• Strong interpersonal skills - coaching and development
• Project and task management 
• Planning and organizing - ability to multi-task and prioritize work
• Critical thinking, decision making and problem solving
• Taking initiative and follow-up
• Attention to detail
• Adaptability - desire to work in a dynamic, fast-paced environment