Molecular Templates Inc
  • Austin, TX, USA
  • Full Time

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:

The Quality Control (QC) Manager will primarily manage the GMP QC laboratory at MTEM. This position will qualify, perform, and monitor QC methods for product testing as well as perform QC testing for environmental monitoring and on in-process, product, stability and/or research samples and other operational activities. This position will also lead in identifying continuous process improvement areas, compliance with GMP processes and documentation for quality control activities with a high degree of accuracy and efficiency. 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:

  • Quality, perform, and monitor QC methods for product testing which are technically sound, compliant with regulatory statutes, and executed with a high level of excellence; manage cGMP product stability and release testing and produce data summaries; effectively analyze and communicate Quality data and metrics to upper management; monitor and maintain facility and equipment for use in GMP activities. This requires maintaining knowledge of scientific trends and industry processes through readings, conferences and seminars and reviewing literature to enhance or improve QC procedures and methods.
  • Manage QC team to ensure that testing requirements are being met on schedule
  • Manage the QC testing of raw materials, in-process, product, stability and/or research samples. This involves, but is not limited to, measurement of protein concentration levels (NanoDrop), capillary gel electrophoresis (CGE), cellular cytotoxicity assay, endotoxin detection, high-performance liquid chromatography (HPLC), Cation Exchange (CEX), testing documentation, and calibration of equipment.
  • Manage the ongoing testing at contract labs
  • Oversee the execution of stability and validation testing on assays including data management and analysis
  • Develop and execute validation protocols for new and existing equipment and methods as required.
  • Oversee the maintenance of QC operations
  • Author new SOPs, plus review and revise established SOPs, related to quality control testing and operations. This may also include developing and optimizing assays, conducting literature search of research study protocols and reports, regulatory documents, and other potential resources.
  • Oversee the completion of additional projects, for example process improvements, spreadsheet validation, or implementation of new instrumentation
  • Serve as QC representative on project and product teams, deliver information and action items from cross-divisional meetings to team members. Act as the primary point of contact to provide status updates and problem resolution.

 

Qualifications:

  • Bachelor's degree from accredited institution in life science, chemistry, pharmaceutical science or related field. Master's degree a plus.
  • A minimum of seven (7) years of related professional experience in QC laboratory setting, with at least four (4) years of QC Management position. Experience in supporting a GMP manufacturing environment required
  • Experience in analytical methods development, optimization, and validation required.
  • Experience maintaining mammalian cell lines using aseptic technique, conducting analytical protein assays such as SDS-PAGE, CGE, SE-HPLC, and CEX required.
  • Experience in cell based biological assays required
  • Demonstrated experience in team building and team management
  • Excellent problem-solving and analytical skills applied to investigations
  • Excellent project management, time management, and multi-tasking skills
  • Excellent written and verbal communication skills
  • Ability to manage competing priorities or projects
  • Ability to function independently and exercise good judgement
  • Ability to independently identify problems and solutions then take action to resolve
  • Demonstrated ability to resolve operational and strategic issues
  • Work with multiple functional/departmental personnel at various levels in the facility. Ability to work with multi-departmental team.
  • Ability to apply attention to detail as applied to data review and compliance
  • High degree of reliability and professionalism

 

Reporting Structure:

This position has supervisory responsibilities.  This position reports to the Director of Quality Control.

 

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

Molecular Templates Inc
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