Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life. We are passionate about what we do!RESPONSIBILITIES:
Job performance will involve a variety of activities including:
- Lead the overall team performance and pacing towards all monthly and quarterly goals and metrics
- Report regularly on the data, performance, and activity of the teams supporting
- Staff and train operational areas at appropriate levels with appropriate backgrounds, establish performance standards and provide professional growth opportunities
- Provide leadership and direction to the operations and production staff, including active troubleshooting leading to action plans for continuous improvement
- Build and cultivate a continuous improvement program and culture focusing on lean manufacturing processes.
- Acquire a strong solid understanding of the production processes and all associated equipment, as well as acting as a back-up to support daily results
- Work closely with senior management to develop policies, procedures and systems and to follow through with implementation and enforcement.
- Contribute to and implement continuous improvement of processes for receiving product, equipment utilization, manufacturing, inventory management and shipment of PCM product
- Own operational documentation to support commercialization and scale-up of PCM, including but not limited to Phase Gate Reviews, Manufacturing Readiness, Validation Plan review, etc.
- Work cross-functionally to implement production scale-up activities while driving consistency across all product lines in the platform
- Supervise and lead to the Operational Capacity Plan
- Maintain and revise SOP's and cGMP documentation
- Maintain a relationship with key operations partners (including Quality, Engineering, Supply Chain, etc.)
- Contribute to strategic plans and reviews, prepare and complete strategic action plans
- Drive a team-focused “Safety First, Quality Always” culture while implementing production, efficiency, and quality/regulatory compliance
- Develop and maintain a thorough understanding of Invitae clients and the IVD assay market.
- Help promote a company culture that encourages top performance and high morale.
- Maintain Invitae values and mission within department, and plan for short and long-term goals.
- Review, understanding, and compliance with Invitae HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as advised by Invitae for purposes of personalized molecular pathology.
- 6+ years’ experience in an operations, manufacturing, or related environment.
- Minimum of 2 years’ experience leading people and projects
- Previous experience manufacturing medical devices in a regulated environment
- History of successful performance in a fast-paced environment with a proven track record to make important decisions, often under pressure and tight deadlines.
- Experience leading sophisticated cross-function projects/programs.
- Functional knowledge of key business processes in a medical device manufacturing environment.
- Expert proficiency at managing day-to-day operational aspects of a project and scope.
- Demonstrates the ability to lead projects and teams, multi-task and achieved desired results, especially under pressure.
- Demonstrates strong verbal, listening and written communication skills, organizational and time management skills, presentation skills and attention to detail.
- Ability to translate broad strategies into specific objectives and action plans.
- Demonstrates strategic and critical thinking with strong analytical and problem-solving skills.
- Self-starter driven to perform with ability to organize, prioritize, and delegate tasks to efficiently move projects forward.
- Independent decision-making capability and ability to think conceptually and understand impact of decisions critical to product quality
- Bachelor’s degree in a Scientific or Engineering field from an accredited institution. Advanced degree a plus.
In Colorado, our competitive compensation package includes a base salary starting from $125,000 per year. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.