Site Microbiologist, Quality Control

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 Site Microbiologist to provide leadership to the Quality Control organization supporting a biologics manufacturing facility located in Austin, TX. Responsibilities of this group include microbial testing, microbial identification, in-process analysis, facility monitoring testing, program maintenance, and raw material testing.

The successful candidate will supervise in a matrix style a team of Associates and Analysts executing microbiology, facility monitoring, raw material, and STAT testing for the GMP manufacturing facility. They will be the site microbiology subject matter expert and manage the daily operations for these activities.

The role will include trending analysis, implementation, and phase appropriate validation of test methods, documenting deviations and CAPAs, and conducting investigations. Additional responsibilities will include enhancement of testing programs, identification and implementation of efficiency improvements, personnel onboarding, departmental budgeting, resource forecasting, definition of annual goals, daily management and development of laboratory personnel, and equipment maintenance.

The position requires a highly motivated individual who can work independently and represent Quality Control on integrated teams that include Quality Assurance, Validation, Compliance, Manufacturing, Supply Chain, and Process/Analytical Development personnel.

Job Responsibilities will include:

• Perform and oversee product and facility testing related to microbiological assays, review data and interpret and report results
• Act as subject matter expert on microbiological assays, method qualification, technical troubleshooting, and instrument validation
• Conduct and manage schedule of microbial testing and identification
• Maintain and oversee environmental monitoring, clean utilities and cleaning verification programs in a regulated environment
• Prepare data trending reports, and author, review and revise test methods, qualification protocols, SOPs and reports
• Anticipate method and instrument performance issues and troubleshoot complex technical problems
• Review and approve contract labs protocols, reports and testing results pertaining to microbiology testing.
• Represent QC Microbiology on cross-functional teams and prepare and present data to internal and external clients
• Implement change controls, lead investigations, and complete CAPAs in support of GMP operations
• Responsible to partner with Quality Operations to ensure all quality and regulatory requirements are being met
• Identify and implement continuous improvement projects for lab process efficiencies
• Support the in process, release and stability testing assuring compliance and timelines are achieved

Qualifications:

• BS/BA or MS/MA in biological or chemical sciences with an emphasis on microbiology with at least 12 years of related experience, required, OR:
• PhD in biological or chemical sciences with an emphasis on microbiology with at least 6 years of related experience, required
• At least 3 years prior personnel management and supervisory experience with desire to train laboratory personnel in basic and complex laboratory techniques and to mentor staff for personal growth and development, required
• Previous laboratory experience in a microbiology testing supporting cGMP biologics manufacturing facility, required
• In-depth knowledge of microbial testing and identification
• Familiarity with protein content and purity testing
• Use and/or administration of sample management and LIMS systems
• Demonstrated proficiency with Excel, JMP or other statistical based software
• Proficiency in raw material testing and material specification system implementation
• Desire to drive group strategy and provide tactical support to managers
• Experience supporting internal corporate audits as microbiology subject matter expert
• In-depth knowledge of US and international regulatory requirements
• Capable of making risk-based decisions and possessing critical thinking and problem-solving skills
• Prior interactions with domestic and international regulatory agencies, preferred
• Experience performing real time in-process testing for manufacturing forward processing
• Experience qualifying/verifying test methods and instrumentation including supporting documentation
• Demonstrated knowledge of and ability to apply cGMP and quality system regulations
• Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
• Ability to work on assigned projects independently with limited supervision

Reporting Structure:

This position has supervisory responsibilities. This position reports to the Director of Quality Control.

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

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