Quality Control (QC) Supervisor

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) Supervisor will primarily supervise QC processes, programs and conduct QC activities. This position will develop and implement standards, methods, and procedures for all stages of product testing; as well as perform QC testing on in-process, product, stability and/or research samples and other operational activities. This position will identify continuous process improvement areas, in compliance with GMP processes and documentation for quality control activities. This requires 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:

• 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.
• Implement standards, methods and procedures to inspect, test and evaluate accuracy and reliability of company products in compliance 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 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.
• Direct 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.
• Execute validation protocols for new and existing equipment and methods; direct stability and validation testing on assays, and conduct data management and analysis; as required.
• Identify continuous process improvement areas, in compliance with GMP processes and documentation for QC activities with a high degree of accuracy and efficiency
• Supervise 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 new SOPs, 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
• Select, develop, evaluate and supervise personnel to ensure efficient operation of Quality Control

Qualifications:

• Bachelor's degree from accredited institution in life science, chemistry, pharmaceutical science or related field. Advanced Degree, preferred
• Minimum of seven (7) years of related professional experience in laboratory setting, with at least four (4) years of QC role
• Minimum of two (2) years direct supervisory experience
• 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, SE-HPLC, environmental monitoring, and Cation Exchange Chromatography.
• Experience in biopharmaceutical industry, required
• Thorough knowledge of cGMP regulations, quality systems and regulatory requirements.
• 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, 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 will have supervisory responsibilities. 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