Quality Control (QC) Analyst

Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. 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 conduct routine and non-routine QC testing and analysis, including but not limited to biochemical and chemical analysis, of raw materials, in-process items and finished product according to established operating procedures. This position will also compile and review data for compliance, prepare summaries and reports, revise standard operating procedures and may develop testing and analysis methods and procedures in accordance with established guidelines. This requires 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), testing documentation, and calibration of equipment (e.g. pipette, etc.). Basic lab equipment utilized.
• Conduct maintenance of QC operations, such as quarterly validation, 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 drug development. 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 five (5) years of related professional experience in laboratory setting, with at least two (2) years QC or bioanalytical role
• Experience in GMP QC test lab environment, required
• Experience maintaining mammalian cell lines using aseptic technique, conducting analytical protein assays such as SDS-PAGE, CGE, and SE-HPLC, preferred
• Experience in biopharmaceutical industry, preferred
• Significant and demonstrated knowledge of laboratory equipment, product use, and terminology
• Excellent problem-solving and analytical skills applied to investigations
• Excellent project management, time 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 manage competing priorities and projects
• Ability to function independently and exercise good judgement
• Ability to identify problems and solutions then take action to resolve
• Ability to understand instructions and to learn how to maintain equipment
• Ability to apply attention to detail as applied to data review and compliance
• High degree of reliability and professionalism

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

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