СШАStaff Technical Operations Scientist
1 нед. назад
СШАLeadHybrid
next-generation sequencingcliaroot cause analysiscapaschange control
Responsible for supporting Manufacturing Science and Technology with a focus on Next-Generation Sequencing workflows and root cause analysis in a CLIA lab setting.
О компании
- At , we are seeking a Staff Technical Operations Scientist to help grow the Manufacturing Science and Technology (MSAT) team. The ideal candidate is in Next-Generation Sequencing (NGS) workflows, detail-orientated, and familiar working within a CLIA laboratory setting. This person is responsible for all things related to Technology transfer and supporting root cause analysis of commercial issues. You are passionate about contributing to developing life-saving diagnostics through early cancer detection, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.
- The role reports to the Senior Manager of Technical Operations. This role will be a Hybrid role based in our Brisbane, California headquarters.
Обязанности
- Support day-to-day Manufacturing/QC and Clinical Lab operations by providing scientific and technical guidance.
- Monitor process performance and analyze manufacturing/QC data to identify trends, variability, and opportunities for improvement.
- Lead investigations related to Manufacturing/QC nonconformances, out-of-specification (OOS) results, and process excursions using root cause analysis tools.
- Author Nonconformances reports, CAPAs, change controls, risk assessments, and technical documentation.
- Collaborate with cross-functional teams to implement corrective and preventive actions that improve process reliability and product quality.
- Lead process validation, equipment qualification, and technology transfer activities.
- Participate in Manufacturing/QC readiness activities for new products or process changes.
- Create validation documentation for Manufacturing/QC and ensure accuracy and compliance with GMP requirements.
- Create statistical analyses and preparation of technical reports to support process monitoring and decision-making.
- Lead continuous improvement initiatives focused on process chemistry efficiency.
- Maintain knowledge of applicable regulatory requirements, GMP guidelines, and company procedures.
- Present technical findings and project updates to internal stakeholders.
Требования
- Bachelor's degree in Chemistry, Biology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
- 12 years of experience in pharmaceutical, biotechnology, medical device, or related regulated manufacturing environments (internships and co-op experience may be considered).
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work effectively in a cross-functional, team-oriented environment.
- Proficiency with Microsoft Office applications, particularly Excel and PowerPoint.
- Experience with NGS workflows and chemistry.
- Experience working in a GMP-regulated environment, CAP/CLIA, ISO13485 or IVD environment.
- Knowledge of process validation principles and test method validation.
- Experience with manufacturing investigations, CAPA, change control, or quality systems.
- Experience with automated Liquid handling such as Hamilton/Tecan.
- Experience with statistical software such as JMP or Minitab/Python/R.
Будет плюсом
- Exposure to Lean, Six Sigma, or continuous improvement methodologies.
- Experience using systems such as Netsuite, LIMS, or electronic batch records.
Условия
- The US target range of our base salary rate for new hires is $157,675.00 - $221,550.00 . You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ .com/job-openings/ for additional company information.
- Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Employee Polygraph Protection Act (EPPA)
- California applicants please review the CCPA Notice at Collection here:
- California Consumer Privacy Act (CCPA)
- #LI-HYBRID