Molecular Templates Inc
  • Austin, TX, USA
  • 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 a highly-motivated professional to support cGMP documentation efforts for production. This Specialist will support preparation and updates of documentation. Primarily, this role will focus on creation, compilation, and review of controlled/managed documents. Also, this role will be involved in review of executed document to identify entry errors, omissions, missing data and GDP corrections. This position will work in close collaboration with other departments, such Manufacturing, QC and QA, Supply Chain and Warehouse to ensure workflow and compliance standards. This position will require technical writing skills and knowledge of bioprocesses, attention to detail, organizational skills, along with ability to operate under supervision and independently, and manage competing priorities and timelines.

 

Job Responsibilities will include:

  • Prepare, route, review, approve new and revised controlled/managed documents.
  • Review documents submitted to ensure the correct use of templates, content and document types
  • Perform advanced word processing and assists MTEM personnel in resolving document format issues
  • Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedure
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system
  • Support audits (internal & external) in order to verify that regulatory and quality requirements have been met
  • Perform other duties as assigned

Qualifications:

  • Minimum of two (2) years of technical writing/document control experience in the biotech/pharmaceutical industry
  • Bachelor's degree or equivalent combination of related education and experience
  • Comprehensive knowledge of cGMP regulation applicable to the FDA and comparable international regulatory agencies
  • Extended experience with Microsoft Word and Excel spreadsheet creation/management
  • Experience with Visio or similar flow chart generation software, preferred
  • Excellent written and verbal communication skills
  • Excellent technical, analytical and problem-solving skills
  • Excellent organizational, project management and multi-tasking skills
  • Ability to apply basic scientific knowledge and regulatory principles
  • Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment
  • Ability to work collaboratively with cross-functional teams and contractors in order to drive results and meet company objectives
  • Ability to function under supervision and independently, and exercise good judgement

Reporting Structure:

This position has no supervisory responsibilities. This position reports to Sr. Manager, GMP Manufacturing.

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

Molecular Templates Inc
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