Manager Process Development
Job description
About the role
The Manager of Process Development plays a pivotal role in overseeing technology transfers and enhancing workflows within the Extractions Lab. This position involves close collaboration with the Director of Extractions Operations to ascertain resource requirements and to lead a team dedicated to managing change control and documentation processes. As a key player in the organization, you will be instrumental in driving operational excellence and ensuring compliance with industry standards.
Key facts
What you'll do
- Align the activities of the team with the strategic objectives set by senior management for the Extractions department, ensuring that all initiatives support the broader goals of the organization.
- Develop and refine procedural documentation to enhance both accuracy and usability, making it easier for team members to follow established protocols.
- Lead a dedicated team that prioritizes operational success, quality assurance, and timely project delivery, fostering a culture of excellence.
- Identify opportunities for workflow improvements and implement changes that boost efficiency and productivity across the lab.
- Serve as the main point of contact for Extraction teams during product launches, ensuring smooth transitions and effective communication.
- Collaborate with various stakeholders, including engineering, equipment management, quality assurance, and regulatory compliance teams, to ensure seamless operations.
- Provide mentorship and guidance to direct reports, facilitating their professional growth through structured training and development plans.
- Ensure compliance with company policies regarding the handling of protected health information (PHI), adhering to security and privacy regulations.
Requirements
- A Ph.D. in Molecular Biology or a closely related discipline, or an equivalent level of education and experience.
- At least 6 years of relevant industry experience, particularly in genetic testing or similar fields.
- Proven experience in a managerial capacity, demonstrating leadership and team management skills.
- Familiarity with working in regulated environments, including GMP, ISO, CLIA, CAP, or FDA standards.
- A robust technical foundation in molecular biology and next-generation sequencing (NGS) assays.
- Experience in assay design, troubleshooting, and the development of diagnostic tests.
- Physical capability to lift up to 20 pounds and perform tasks in both laboratory and office environments.
- Willingness to work outside of standard business hours, including weekends, as necessary to meet project deadlines.
Nice to have
- Previous experience in assay development or quality control processes.
- Background in providing laboratory support in CLIA or FDA-regulated settings.
- Familiarity with formal quality management systems, enhancing the ability to maintain compliance.
Skills & tools
- Proficiency in molecular biology and NGS laboratory assays, ensuring high-quality results.
- Expertise in developing Standard Operating Procedures (SOPs) that guide laboratory practices.
- Strong understanding of quality management principles and regulatory compliance requirements.
- Skills in project management and process optimization to drive continuous improvement.
- Leadership abilities that foster team collaboration and individual growth.
Practical notes
- This position necessitates the completion of HIPAA and PHI privacy compliance training within the first 30 days of employment, ensuring adherence to legal standards.
- The compensation package includes an annual performance bonus, long-term equity options, a 401(k) plan with matching contributions, and comprehensive health benefits to support employee well-being.
- Natera communicates exclusively through @natera.com email addresses; candidates are advised to remain vigilant against potential recruitment scams.
In this role, you will have the opportunity to make a significant impact within a leading organization in the genetic testing field. Your contributions will not only enhance the efficiency of laboratory operations but also support the overall mission of Natera in delivering high-quality diagnostic solutions. If you are passionate about process development and have the requisite experience, we encourage you to apply and join our dedicated team in San Carlos, CA.
About the company
Therapeutics & Innovations Nateraâs Therapeutics & Innovations group is at the forefront of applying AI, genomics, and multimodal data to transform precision medicine. From building genomic foundation models to developing predictive AI platforms, our mission is to accelerate biomarker discovery, improve clinical trial design, and enable novel personalized therapeutics.