Quality Control (QC) Associate

Location
Austin, Texas
Posted
Jul 16, 2018
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company focused on the development of a next generation immunotoxin platform technology called Engineered Toxin Bodies (ETB) in oncology. MTEM's lead program, MT-3724, is in clinical development for non-Hodgkin's lymphoma and additional pipeline drug candidates are being advanced toward clinical

development for a variety of cancers. For more information, please visit MTEM's website at

www.mtem.com.

 

Position Overview:

Molecular Templates is seeking a highly-skilled and highly-motivated professional to support QC activities. The QC Associate 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 (NanoDrop), capillary gel electrophoresis (CGE), cellular cytotoxicity assay, endotoxin detection, high-performance liquid chromatography (HPLC), physical testing (pH, Appearance) testing documentation, and calibration of equipment (e.g. pH/Conductivity, Nanodrop, etc.). Basic lab equipment utilized.
  • Assist in 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

 

Qualifications:

  • Bachelor's degree from accredited institution in life science, chemistry, pharmaceutical science or related field
  • Minimum of two (2) years of relevant experience in GMP environment, preferably in QC position. 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 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 Quality Control Manager.

 

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



For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://mtem.isolvedhire.com/jobs/31691-19034.html