Quality Control (QC) Analyst

Austin, TX, USA
Oct 28, 2020
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Molecular Templates is seeking a highly-skilled and highly-motivated professional to support QC activities. The QC Analyst will primarily support quality control (QC) testing on in-process, product, stability/release and/or research samples and other operational activities. Along with testing samples, this position will conduct routine maintenance checks and perform equipment validation, data management, stability and reliability validation, review and revision of established protocols and SOPs and method development. This position will require excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, verbal and written communication skills, plus ability to apply attention to detail.

Job Responsibilities will include:
  • Perform QC testing on in-process, product, stability/release and/or research samples. This involves, but not limited to, measurement of concentration levels (A280), capillary gel electrophoresis (CGE), cellular cytotoxicity assay, endotoxin detection, ultra and high-performance liquid chromatography (UPLC and HPLC), physical testing (pH, Appearance) testing documentation, and calibration of equipment (e.g. pH/Conductivity, Nanodrop, etc.)
  • Complete ongoing environmental monitoring (Viable/Non-viable air, settling and contact plates, water testing).
  • Conduct maintenance of QC equipment and operations, including lab and equipment cleaning, minor equipment maintenance and small projects, maintaining and managing lab materials (e.g. supplies, cell stock), completion of documentation (e.g. equipment logbooks, inventory forms).
  • Execute stability and reliability validation testing on assays and data management and analysis, generally using Excel spreadsheets.
  • Review and revise established protocols and SOPs related to bulk drug substance and drug product testing. This may also include developing and optimizing assays, conducting limited literature search of research study protocols and reports, regulatory documents, and other potential resources.
  • Complete additional projects, for example: process improvements or implementation of new instrumentation

  • Bachelor's degree from accredited institution in life science, chemistry, pharmaceutical science or related field, required.
  • Two (2) to five (5)+ years of relevant experience in QC Testing in a GMP environment required.
  • Experience in environmental monitoring a plus.
  • Experience with analytical methods and optimization, maintaining mammalian cell lines using aseptic technique and conducting analytical protein assays, such as SDS-PAGE, CGE, FPLC, SE-HPLC, UPLC, and Flow Cytometry.
  • Significant and demonstrated knowledge of laboratory equipment, product use, and terminology.
  • Excellent analytical skills as applied to investigations and mathematical problem-solving
  • Excellent organizational, time management, project management and multi-tasking skills
  • Excellent written and verbal communication skills
  • Excellent computer skills with knowledge of spreadsheet, word processing and statistical analysis software
  • Ability to understand verbal and written instruction and work under minimum supervision
  • Ability to understand instructions and to learn how to maintain equipment
  • Ability to apply attention to detail, specifically to GMP compliance
  • High degree of reliability and professionalism

Reporting Structure:

This position has no supervisory responsibilities. This position reports to Supervisor, Quality Control.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com