28 days old

Director, Quality Control

Molecular Templates Inc
Austin, Texas 78729
  • Job Type
    Employee
  • Job Status
    Full Time

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 an experienced and highly-motivated professional to lead quality control efforts. The Director will oversee the development, implementation and maintenance of quality systems for QC and activities to meet 21 CFR Part 211 compliance.  This position monitor audits of production and quality control areas. This requires excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, interpersonal skills, plus ability to apply attention to detail

 

Job Responsibilities will include:

 

  • Develop the long-term QC strategy to support company growth and expansion into additional operations.
  • Oversee the operations of a Quality Control department which supports GMP Bulk Drug Manufacturing (environmental monitoring, in process testing, release testing, stability testing), Drug Product testing (release and stability testing), stability programs, method development and validation, and material release.
  • Monitor audits of production and Quality Control areas, such as batch record review and release, nonconformities, technology transfer, scale-up, validation, training and other GMP activities
  • Lead investigations and resolve potential product quality issues to improve efficiency. 
  • Develop, implement and maintain the activities of quality control systems.
  • Oversee development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.   
  • Manage method development, method qualification, and method validation activities in the MTEM lab and at third party labs.
  • Provide guidance and strategy in the setting of specifications and identification of appropriate bulk drug substance and drug product testing.
  • Make recommendations for corrective action necessary to ensure conformity with quality specifications. 
  • Ensure finished products conform to government and Company standards and satisfy good manufacturing practices regulations. 
  • Coordinates interdepartmental activities.
  • Select, develop and evaluate personnel to ensure the efficient operation of the function.
  • Complete additional projects, for example process improvements

Requirements

Qualifications:

 

  • Bachelor's degree in life science, chemistry, pharmaceutical science or related field, required; Advanced degree, preferred
  • Minimum of ten (10) years of related professional experience in QC
  • Thorough knowledge of cGMP regulations, 21 CFR Part 211, quality systems, and regulatory requirements
  • Proven experience in the development, qualification, and validation of assays.
  • Experience in cell-based assays, including method development, a plus.
  • Experience in SE-HPLC, including method development, a plus
  • 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 interpersonal 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, exercise good judgement and work in a team-based environment
  • Ability to identify problems and solutions then act to resolve
  • Demonstrated ability to resolve operational and strategic issues
  • 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

 

Reporting Structure:

This position will have supervisory responsibilities for Quality Control. This position reports to VP, Quality.

 

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/72649-68400.html

Categories

Posted: 2019-08-21 Expires: 2019-09-20

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Director, Quality Control

Molecular Templates Inc
Austin, Texas 78729

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