Manufacturing Technology Specialist

Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics.  Our proprietary biologic drug platform technology, known as engineered toxin bodies, or ETBs, leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer and other serious diseases.  MTEM currently has multiple clinical-stage E Molecular TB candidates in development including MT-5111, MT-0169, and MT-6402.  Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development.  Additional information about Molecular Templates can be obtained at www.mtem.com.    

 

Position Overview:

 

Molecular Templates is seeking a an energetic and highly motivated professional to play a key role within technical operations at the 9301 GMP manufacturing facility. The Manufacturing Technology Specialist will contribute to the development, planning, implementation, and maintenance of manufacturing methods, processes, and operations for GMP production activities. This position will ensure the effective use of materials, equipment, and employees in producing quality products; recommend and author manufacturing policies and procedures; and prepare documentation, reports, and SOPs as required. Additionally, this position will work closely with quality, engineering, development, and supply chain teams as well as with internal/external stakeholders and senior leadership to ensure good manufacturing practices and guidelines as well as corporate goals and strategic objectives are met. This position 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:

 

• Lead cross-functional risk assessments, facility fit assessments, continuous improvement projects and other manufacturing readiness activities to support GMP operations
• Lead manufacturing readiness activities in collaboration with development teams to enable tech transfer and scale-up of new or modified biological processes
• Lead introduction of new technologies and new equipment into GMP manufacturing
• Author, review and/or approve investigations, CAPAs, SOPs, change controls, and batch records as required to support GMP operations
• Work with cross functional teams to develop project timelines, charters, scope statements, project execution plans, and communication plans related to GMP operations. Provide regular updates to sponsors, stakeholders, and steering committees as needed
• Work with supply chain to create the Bill of Materials and to forecast raw materials and consumables required for upcoming GMP campaigns
• Work with engineering to support future capital projects and to ensure maintenance of process equipment and the manufacturing facility
• Support manufacturing operations. Display and promote compliance with current corporate policies, regulatory guidelines, and safety practices
• Proficiently troubleshoot process equipment and process automation for manufacturing operations. Responsible for interacting with external vendors for equipment and automation support
• Identify and lead process improvement efforts, particularly for optimization, efficiency, and growth
• Review and approve single-use consumable drawings required for GMP manufacturing.
• Actively participate in an environment which fosters safety, quality, and continuous improvement

 

 

Qualifications:

 

• Bachelor’s degree in life sciences, engineering, or equivalent experience required
• Minimum of 3 years of relevant experience within a GMP manufacturing environment, a clean room environment, or a highly regulated environment required (6+ years preferred)
• Applicable knowledge of safety principles, regulatory requirements, and quality systems is required
• Prior experience and knowledge with fermentation & protein purification operations and GMP process equipment is required
• Prior experience within a GMP manufacturing environment, a clean room environment, or a highly regulated environment is required
• Demonstrated ability to work collaboratively and maintain a positive, productive relationship with cross-functional team members
• Demonstrated ability to work independently and manage multiple projects and competing priorities simultaneously
• Demonstrated ability to problem-solve and provide solutions to challenges or obstacles
• Proficient computer skills with knowledge of spreadsheet and word processing
• Ability to understand and exercise advance mathematical calculations
• Experience with operational excellence tools and methods, preferred
• Excellent communication skills, written and verbal
• Highly organized and detail oriented
• Flexible, resourceful, and comfortable working in a fast-paced, complex, dynamic team environment

 

Reporting Structure:

 

This position does not have supervisory responsibilities. This position reports to the Director of Manufacturing.

 

Molecular Templates celebrates and supports our differences and is proud to be an Equal Employment Opportunity employer.  We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, veteran status, disability, or any other legally protected characteristic.   

MTEM is committed to providing reasonable accommodations for qualified individuals.  If you need assistance with your application due to a disability, you may contact us at: careers@mtem.com. 

By submitting a resume for consideration, applicants verify that they have read MTEM’s Applicant Privacy notice. https://www.mtem.com/privacy-policy