Quality Control (QC) Manager - Austin, TX | Biospace
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Quality Control (QC) Manager

Molecular Templates

Location:
Austin, TX
Posted Date:
6/29/2017
Position Type:
Full time
Job Code:
78729
Salary:
Competitive
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Analytical Chemistry, Assay, Drug Discovery, HPLC, Operations, Project Management, QC, Quality, Quality Control,

Job Description

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 lead quality control efforts. The Quality Control (QC) Manager will primarily manage QC procedures and programs and conduct QC activities. This position will develop, qualify, perform, and monitor QC methods for product testing as well as perform QC testing 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:
•   Develop, qualify, 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 R&D and 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.
•   Perform QC testing on in-process, product, stability and/or research samples. This involves, but not limited to, measurement of protein concentration levels (NanoDrop), capillary gel electrophoresis (CGE), cellular cytotoxicity assay, endotoxin detection, high-performance liquid chromatography (HPLC), testing documentation, and calibration of equipment. Basic lab equipment utilized.
•   Coordinate with contract labs regarding on-going testing
•   Execute stability and validation testing on assays and data management and analysis
•   Develop and execute validation protocols for new and existing equipment and methods as required.
•   Conduct maintenance of 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).
•   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 limited literature search of research study protocols and reports, regulatory documents, and other potential resources.
•   Maintain laboratory supplies through ordering and preparation of reagents and other media, plus and laboratory sanitization and organization
•   Complete additional projects, for example process improvements, spreadsheet validation, or implementation of new instrumentation

Reporting Structure:
This position currently has no supervisory responsibilities but will have a lead role in Quality Control operations. This position reports to Sr. Director of Quality.

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

Requirements

•   Bachelor’s degree from accredited institution in life science, chemistry, pharmaceutical science or related field
•   A minimum of seven (7) years of related professional experience in laboratory setting, with at least four (4) years of QC/QA position. Preferred experience in GMP manufacturing environment, analytical methods and optimization, maintaining mammalian cell lines using aseptic technique, conducting analytical protein assays such as SDS-PAGE, CGE, and SE-HPLC.
•   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 or projects
•   Ability to function independently and exercise good judgement
•   Ability to identify problems and solutions then take action 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