Job Summary

Sr. Technical Lead position is highly skilled at the assigned manufacturing processes, technology, equipment, and quality system requirements needed to manufacture Autoimmunity products. This position works closely with department management, staff and partner departments to proactively prevent, identify and resolve issues related to the effective use of resources and operational processes impacting product quality, with a special focus on troubleshooting, investigations and root cause analyses.  Serves as a subject matter expert to staff through training and problem solving.  Supports department management to ensure department goals, deadlines and performance standards are met.  Works under the direct supervision of department management.  Responsible for performing department production work when not performing other duties.  Ensures all activities are performed in accordance with standard operating procedures, Quality Systems, safety and administrative regulations.

Key Accountabilities

• Serves as a subject matter expert on manufacturing processes, technology, equipment, and Quality System requirements.
• In collaboration with department management and R&D, plans and executes the transfer of products from Research and Development into Manufacturing, including new assays, design changes, and vendor qualifications.
• Participates and/or leads equipment and process design, feasibility, and validation efforts.
• Plans and leads cross-functional troubleshooting projects, continuously providing detailed project plans, schedules, results, conclusions, action items, meeting minutes, etc. to the team. Makes recommendations to management and implements approved solutions.
• Collects and analyzes data, prepares and presents reports and recommendations to improve product quality and achieve business goals.
• Leads design of experimentation efforts for a rational experiment outline and root cause analysis.
• Leads the investigation and generates reports for product non-conformance and root cause analysis, providing timely updates during meetings and review boards.
• Identifies training gaps and needs. Develops and delivers training to staff on the process of manufacturing troubleshooting.
• Develops and delivers training on the evaluation of experiment results, including conclusions, next steps, and escalation points.
• Assesses competency and quality to identify training gaps and needs. Recommends and develops training to continually improve performance and quality.
• Serves as a technical resource to staff in the department and across the organization on new or improved processes and technology.
• Under the direction of department management helps coordinate the flow of work through the department and provides input into work schedules and priorities.
• Identifies skill, knowledge and resource needs. Provides input to department management for workforce planning, staff development and performance management activities.
• With department management, may sit in on interviews or other employee meetings to provide technical expertise.
• Performs other duties and projects as assigned to meet company and department objectives.
• Promotes team compliance with applicable Inova SOPs, ISO, FDA and other Quality System Regulations, as well as applicable Environmental, Health & Safety, Human Resources and all other regulatory and administrative policies.
• Reflects company Values in the quality of work and working relationships.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

• Quality Testing Team
• Quality Product Support Team
• Quality Complaints Team
• Research and Development, including Manufacturing Technical Service (MTS)
• Biochemistry Team

Education and Experience:

• Bachelor’s degree in the biological or related sciences required.
• 5+ years work experience in a laboratory environment required, within life sciences or medical devices strongly preferred.
• Demonstratived experience and a track record of success in developing, delivering and assessing employee training.
• Demonstrated experience in evaluating product quality to meet Quality System requirement and customer needs, and successful participation in in troubleshooting, root cause analysis and contributing to product improvement activities.

Skills & Capabilities

• Extensive knowledge of bead-based chemistry.
• Understanding of, and commitment to, Quality Systems Regulations required.
• Experience with Enterprise Resource Planning (ERP) systems required, SAP strongly preferred.
• Understanding of standard administrative and business procedures required.
• Ability to plan, organize and lead multiple projects required.
• Skilled at manufacturing related troubleshooting, critical thinking, and project management required.
• Strong emotional intelligence, communication and collaboration skills required, including ability to build consensus and relationships among peers, stakeholders and management required.

Salary Range:

$35./hr - $48/hr

Individual compensation is based on the candidates experience, skills, knowledge, education, certifications, internal equity, budget and or other business and organizational needs.