Senior Statistician, Quality Analytics at Invitae (Greater Boulder Area, CO)
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.Position summary:
As the Senior Statistician, Quality Analytics, you will lead diverse cross-functional teams in the pursuit of quality analytical services in compliance with appropriate regulations such as GMP (good manufacturing practice), GLP (good laboratory practice), and GCP (good clinical practice). Areas of direct influence will include: quality control testing, test method validation, tech transfer, process validation, continual process improvement, product stability program design and execution, laboratory management, product specifications, and risk assessments. This role shall provide strategic leadership to establish and maintain quality levels that consistently deliver best-in-class products that comply with US FDA Regulations.Responsibilities:
- Identify and lead continuous process improvement initiatives that improve the customer experience, enhance workflow, business and manufacturing processes and/or improve the work environment.
- Liaise with early discovery and development partners to drive the continuous flow of knowledge from manufacturing to early research speeding development and reducing time to market for new products.
- Organize and lead all aspects of management of Quality principles for SPC, Quality-by-Design (QBD), Quality Control, Test Method and Process Validation, Tech Transfer and stability teams, including the review and approval of protocols and reports.
- Foster a strong QBD culture striving for continuous quality improvement throughout the entire company.
- Engage in driving the quantitative assessment of specification setting, release limits, process monitoring metrics, and risk assessments.
- Provide strategic analytical leadership throughout the product development process and ensure strong quality domain representation in product development and manufacturing services teams
- Oversee investigations of laboratory issues to insure timely, closed loop corrective actions and reports as required through CAPAs.
- 10+ years experience in two or more of the following areas is required: quality, regulatory, laboratory experience, statistics, engineering.
- Master's Degree in Statistics
- Knowledge of biology, genetics, familiarity with genomic data, proficiency in molecular techniques, NGS preferred.
- Working knowledge of cGMP/CFR/FDA regulations and ISO standards.
- Passion for enhancing healthcare outcomes with novel technology.
- Problem solver, comfortable operating in the grey-space and driving forward with risk balanced decision making.
- History of thriving in a fast-paced, dynamic environment.
- Driven to perform
- Self-directed, curious, and motivated to understand the business, technical, scientific and regulatory aspects of the business.
- Able to organize and prioritize
- Strong leadership and communication skills
In Colorado, our competitive compensation package includes a base salary starting from $130,000 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.