QC Laboratory Operations Coordinator

Location
Austin, TX, USA
Posted
Oct 05, 2020
Ref
181399
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Molecular Templates is seeking skilled and highly motivated professional to help MTEM Quality Control (QC) efforts. QC Laboratory Operations Coordinator will primarily help organize, maintain QC process flow, deliverables, and QC scheduling. This position will support the QC department by maintaining the laboratory, instrumentation, inventory, logbook and whiteboard. This entails ensuring inventory management, task management and tests are completed in a timely manner and keeping them in a qualified state. This position will develop and implement standards, workflow, lab entries and procedures for all stages of product testing; as well as the possibility to perform QC testing on in-process, product, stability and/or research samples and other operational activities as needed. The coordinator will identify continuous process improvement areas, in compliance with GMP processes and documentation for quality control activities. This requires excellent communication skills and abilities. Analytical, mathematical, organizational, and time-management skills are required. Verbal and written communication skills, plus ability to apply attention to details is expected.

Job Responsibilities will include:
  • Support QC operations, scheduling, maintaining workflow, assuring tasks to be done on time, test records are initiated as needed and reviewed on a timely manner
  • Provide test results to management and update reporting sheets to be accessible
  • Report data as needed to support release of GMP lots, stability and facility EM and utilities
  • Help 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 QC facility and equipment for use in R&D and GMP activities; maintain knowledge of scientific trends and industry processes through readings, conferences and seminars and reviewing literature to enhance or improve QC procedures and methods
  • Data entry into QC systems including stability and release data in addition to maintenance of reference standards
  • Identify continuous process improvement areas, in compliance with GMP processes and documentation for QC activities with a high degree of accuracy and efficiency
  • Coordinate QC operations, including lab and equipment cleaning and qualification, 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); maintain laboratory supplies through ordering and preparation of reagents and other media, plus and laboratory sanitization and organization
  • Author review and revise established some SOPs including but not limited to sample receiving, testing initiation and operations. This may also include developing and optimizing assays, conducting limited literature search of research study protocols and reports, regulatory documents, and other potential resources
  • 10-15% travel may be required

Qualifications:
  • Bachelor's degree from accredited institution in life science, chemistry, pharmaceutical science or related field with at least four (4) years in a QC role, required
  • Lean 6 sigma certified, preferred
  • Project, program, or process management experience, preferred
  • Experience in GMP manufacturing environment, analytical methods, and optimization, using aseptic technique, conducting some of the analytical assays such as SDS-PAGE, CGE, SE-HPLC, environmental monitoring, and Cation Exchange Chromatography
  • Experience in biopharmaceutical industry, required
  • Knowledge of cGMP regulations, quality systems and regulatory requirements
  • Significant and demonstrated knowledge of laboratory equipment, product use, and terminology
  • Preferred to have experience with Operational Excellence (OpEx)
  • 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 or 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
  • Ability to travel 10-15% of the time

Reporting Structure:

This position does not have any direct reports. This position reports to the QC Manager.

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

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