Senior Manager - Molecular Manufacturing Operations
Caris Life Sciences
4 hours ago
On-site
Phoenix, AZ
Operations
Position Summary:
The Senior Manager of Molecular Manufacturing Operations is responsible for the technical components of the Molecular Lab within clinical business and manufacturing oversight.
Job Responsibilities:
- Ensure team members receive complete process and theory training for manufacturing processes.
- Direct inventory planning and drive manufacturing schedules to meet clinical and supply chain needs.
- Develop and update SOPs; monitor operations to prevent protocol drift.
- Monitor department metrics and procedure performance (quality control, production efficiency) and report to senior leadership.
- Coordinate cross-functionally during new product transfer to ensure quality/operational details are implemented during validation.
- Work with quality and regulatory teams to maintain manufacturing procedures and/or troubleshoot.
- Manage inventory and scheduling according to business needs.
- Organize and execute studies associated with manufactured components.
- Assist in creating requirements for LIMS improvements and subsequent user acceptance testing.
- Support compliance with applicable regulatory/standard requirements (GMP, FDA, CLIA, NYS, CAP, ISO, etc.).
- Consult with the Laboratory (Medical) Director and other professional staff as needed.
- Recommend hiring, discipline, and promotion; authorize leave and overtime; evaluate and rate performance.
- Maintain confidentiality of patient information per federal, state, and local regulations.
- Represent the manufacturing organization at Management Review meetings.
- Develop, train, and mentor staff.
- Support compliance with CLIA, CAP, NYS DOH, and ISO 15189; assess employee competencies as delegated.
Required Qualifications:
- Bachelor’s degree in a chemical/biological/clinical/medical laboratory science or medical technology (accredited institution).
- 6+ years laboratory experience in high-complexity patient testing, including 1+ year in molecular pathology methods.
- 3+ years leadership experience.
Preferred Qualifications:
- Master’s degree (same fields/areas).
- 6+ years molecular methods experience in a GMP, CUA, NYS, CAP, ISO regulated environment.
- 3+ years leadership experience in a clinical laboratory environment.
- Ability to explain molecular assay experience, including positive/negative controls, sample results, and data interpretation.
- Molecular fundamentals experience: RNA/DNA extraction, PCR, reverse transcription, gel electrophoresis; plus experience with real-time PCR, microarray, fragment analysis, Sanger sequencing, and NGS.
- CLSp(MB) or MB(ASCP) certification.
Physical Demands:
- Ability to sit/stand and work at a computer for long periods.
- Possible exposure to blood-borne pathogens, extreme temperatures, high noise, fumes, biohazardous materials/chemicals (including formalin).
- Visual acuity and analytical skills; ability to pass a color discrimination test.
Training:
- Job-specific safety and compliance training assigned based on job functions.
Other:
- May require periodic travel and some evenings, weekends, and/or holidays.
Conditions of Employment / Application Instructions:
- Complete pre-employment process including criminal background check, drug screening, credit check (for certain positions), and reference verification.
The Senior Manager of Molecular Manufacturing Operations is responsible for the technical components of the Molecular Lab within clinical business and manufacturing oversight.
Job Responsibilities:
- Ensure team members receive complete process and theory training for manufacturing processes.
- Direct inventory planning and drive manufacturing schedules to meet clinical and supply chain needs.
- Develop and update SOPs; monitor operations to prevent protocol drift.
- Monitor department metrics and procedure performance (quality control, production efficiency) and report to senior leadership.
- Coordinate cross-functionally during new product transfer to ensure quality/operational details are implemented during validation.
- Work with quality and regulatory teams to maintain manufacturing procedures and/or troubleshoot.
- Manage inventory and scheduling according to business needs.
- Organize and execute studies associated with manufactured components.
- Assist in creating requirements for LIMS improvements and subsequent user acceptance testing.
- Support compliance with applicable regulatory/standard requirements (GMP, FDA, CLIA, NYS, CAP, ISO, etc.).
- Consult with the Laboratory (Medical) Director and other professional staff as needed.
- Recommend hiring, discipline, and promotion; authorize leave and overtime; evaluate and rate performance.
- Maintain confidentiality of patient information per federal, state, and local regulations.
- Represent the manufacturing organization at Management Review meetings.
- Develop, train, and mentor staff.
- Support compliance with CLIA, CAP, NYS DOH, and ISO 15189; assess employee competencies as delegated.
Required Qualifications:
- Bachelor’s degree in a chemical/biological/clinical/medical laboratory science or medical technology (accredited institution).
- 6+ years laboratory experience in high-complexity patient testing, including 1+ year in molecular pathology methods.
- 3+ years leadership experience.
Preferred Qualifications:
- Master’s degree (same fields/areas).
- 6+ years molecular methods experience in a GMP, CUA, NYS, CAP, ISO regulated environment.
- 3+ years leadership experience in a clinical laboratory environment.
- Ability to explain molecular assay experience, including positive/negative controls, sample results, and data interpretation.
- Molecular fundamentals experience: RNA/DNA extraction, PCR, reverse transcription, gel electrophoresis; plus experience with real-time PCR, microarray, fragment analysis, Sanger sequencing, and NGS.
- CLSp(MB) or MB(ASCP) certification.
Physical Demands:
- Ability to sit/stand and work at a computer for long periods.
- Possible exposure to blood-borne pathogens, extreme temperatures, high noise, fumes, biohazardous materials/chemicals (including formalin).
- Visual acuity and analytical skills; ability to pass a color discrimination test.
Training:
- Job-specific safety and compliance training assigned based on job functions.
Other:
- May require periodic travel and some evenings, weekends, and/or holidays.
Conditions of Employment / Application Instructions:
- Complete pre-employment process including criminal background check, drug screening, credit check (for certain positions), and reference verification.