Lead/Senior Manufacturing Associate

Job highlights
Identified by Google from the original job post
Qualifications
(multiplexed ion beam imaging) Platform breaks through the limitations of traditional IHC, enabling deep
understanding of the tissue microenvironment with highly multiplexed quantitative single-cell analysis
B.S. or M.S in biology, chemistry or a related field
5+ years with B.S/ 3+ years with MS of direct laboratory experience using IHC, IF, FACS, ELISA, or other antibody-dependent assay
2+ years of relevant experience in a reagent manufacturing environment with working knowledge of ISO/GMP/GCLP standards
Deep knowledge of quality system and design control, including validation of processes and equipment
Experience with ERP, PLM and LIMS systems
Excellent organizational skills with meticulous attention to detail
Ability to prioritize and execute experiments with minimal oversight
Ability to pick up new technologies quickly and troubleshoot independently
Benefits
Ionpath is an equal opportunity employer that offers an exciting and collaborative scientific environment, in addition to a competitive compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package
Salary Range: $85,000 - $105,000 depending on experience
Responsibilities
With MIBI technology and the expertise of world class pathology and data science teams, Ionpath
provides actionable insights to translational and clinical researchers at leading pharma, biotech, and
Works on problems of limited scope where analysis of situation or data requires a review of identifiable
Exercises judgment within defined procedures and practices to determine appropriate
Displays good communication skills (both written and verbal)
Supervision
Normally receives general instructions on routine work, detailed instructions on new assignments
Lead Reagent Manufacturing in the Manufacturing and QC of reagents and consumables
Responsible for manufacturing and testing of all reagent manufacturing products/product lines and maintaining reagent stocks at acceptable levels
Perform ERP transactions for material receipt, BOMs, manufacturing orders, and shipping
Process and stain tissue samples for H&E, IHC and MIBI analysis
Perform and troubleshoot immunohistochemistry staining, MIBI staining and antibody conjugations
Support new product development (new reagent formulations and processes), create required documentation – batch records, work instructions and SOPs
Provide training/guidance for manufacturing team members
Perform technical qualifications of reagents and maintain standards for reproducibility and accuracy of results
This position may lead with other manufacturing associates and collaborate with engineers to implement and validate new processes and procedures, troubleshoot equipment, and optimize overall system performance
Ensure and Maintain records and laboratory environment to comply with regulatory requirements, good laboratory practices, and standard operating procedures
Ensure the maintenance and servicing of manufacturing instruments and other laboratory equipment as required
Assist in the development and technology transfer of reagent manufacturing processes and documentation, maintaining the accuracy and validity of testing results
Collaborate cross-functionally to ensure on-time completion of production builds
Any other Manufacturing Operations duties as assigned
Job description
About us

Headquartered in Menlo Park, Ionpath Inc. delivers high-definition spatial proteomics, revolutionizing

tissue imaging and analysis to accelerate discovery and improve human health. Ionpath's MIBI™

(multiplexed ion beam imaging) Platform breaks through the limitations of traditional IHC, enabling deep

understanding of the tissue microenvironment with highly multiplexed quantitative single-cell analysis.

With MIBI technology and the expertise of world class pathology and data science teams, Ionpath

provides actionable insights to translational and clinical researchers at leading pharma, biotech, and

research organizations in immuno-oncology, immunology, neuroscience and infectious disease research.

Job Complexity

Works on problems of limited scope where analysis of situation or data requires a review of identifiable

factors. Exercises judgment within defined procedures and practices to determine appropriate

action. Displays good communication skills (both written and verbal).

Supervision

Normally receives general instructions on routine work, detailed instructions on new assignments.

Job Responsibilities
• Lead Reagent Manufacturing in the Manufacturing and QC of reagents and consumables.
• Responsible for manufacturing and testing of all reagent manufacturing products/product lines and maintaining reagent stocks at acceptable levels.
• Perform ERP transactions for material receipt, BOMs, manufacturing orders, and shipping
• Process and stain tissue samples for H&E, IHC and MIBI analysis
• Perform and troubleshoot immunohistochemistry staining, MIBI staining and antibody conjugations
• Support new product development (new reagent formulations and processes), create required documentation – batch records, work instructions and SOPs
• Provide training/guidance for manufacturing team members
• Perform technical qualifications of reagents and maintain standards for reproducibility and accuracy of results
• This position may lead with other manufacturing associates and collaborate with engineers to implement and validate new processes and procedures, troubleshoot equipment, and optimize overall system performance.
• Ensure and Maintain records and laboratory environment to comply with regulatory requirements, good laboratory practices, and standard operating procedures.
• Ensure the maintenance and servicing of manufacturing instruments and other laboratory equipment as required.
• Assist in the development and technology transfer of reagent manufacturing processes and documentation, maintaining the accuracy and validity of testing results
• Collaborate cross-functionally to ensure on-time completion of production builds
• Any other Manufacturing Operations duties as assigned

Minimum Qualifications
• B.S. or M.S in biology, chemistry or a related field
• 5+ years with B.S/ 3+ years with MS of direct laboratory experience using IHC, IF, FACS, ELISA, or other antibody-dependent assay
• 2+ years of relevant experience in a reagent manufacturing environment with working knowledge of ISO/GMP/GCLP standards
• Deep knowledge of quality system and design control, including validation of processes and equipment
• Experience with ERP, PLM and LIMS systems
• Excellent organizational skills with meticulous attention to detail
• Ability to prioritize and execute experiments with minimal oversight
• Ability to pick up new technologies quickly and troubleshoot independently.

Desired Qualifications:
• Antibody Conjugation experience
• Ability to perform FFPE Tissue Sectioning
• Experience with antibody stability techniques
• Previous experience working at a start-up
• Experience in root cause analysis, quality investigations and CAPA
• Supervisory experience in a start-up environment

Ionpath is an equal opportunity employer that offers an exciting and collaborative scientific environment, in addition to a competitive compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.

Salary Range: $85,000 - $105,000 depending on experience

Ionpath is not able to offer sponsorship at this time.

For more information or to apply apply here or at www.ionpath.com/careers

United States
California
Menlo Park Show on map Get directions