Manager, Calibration and Asset Management

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:

This role is responsible for the management of Calibration and Asset Management within our GMP Manufacturing facilities. This role will be responsible for the detailed planning of facilities, and process maintenance in all MTEM laboratory and GMP Manufacturing facilities. The Manager will be primarily responsible for supporting the maintenance lifecycle management of laboratory, GMP process equipment, critical utilities, facility utilities, building management systems, asset management and site infrastructure. The Manager will fulfill this responsibility through proactive planning and scheduling of facility and equipment work orders, and coordination with contract vendors and documentation of work via the CMMS.

This role will also manage the MRO Stockroom and maintain the spare parts inventory program. This position works directly with Maintenance & Calibration Technicians and Engineers to ensure efficient and effective work execution. Cross functional teamwork and communication are essential attributes as is comfort working in a regulated environment. This role will provide monthly trending and reporting of departmental KPI to upper Management.

Job Responsibilities will include:

• Champion safe working practices ensuring and providing safe work observations, proper controls for stored energy (lock-out, tag out), hot work permits, ensuring appropriate work PPE, hazardous materials storage and handling, spill prevention and response, proper lifting techniques and utilizing proper tools.
• Maintain and manage facility housekeeping standards, including 5S program.
• Schedule routine maintenance and repairs for facility, utilities and equipment.
• Ensure that every maintenance task performed is planned ensuring safety and quality.
• Coordinate with service providers and technical trades.
• Experience with lean tools, preventative and predictive maintenance concepts.
• Interact with cross functional teams, vendors and contractors and report findings and proposals to appropriate stakeholders.
• Communicate with stakeholders to define total scope of work and priority of the work to be performed.
• Determine and outline tasks required to complete work orders
• Manage tasks to completion with team members
• Maintain training compliance to curriculum and technical knowledge to support facility equipment and systems, including basic repairs and maintenance.
• Improve performance of facility and maximizing equipment/facility uptime.
• Responsible for efficient and accurate physical MRO inventory transactions, including but not limited to stocking items received, parts disbursement, returns, inventory audits and adjustments.
• Attends routine meetings with facility management to support in the development of upcoming schedules.
• Resolve and manage order problems such as backorders and slow shipments with outside vendors. Helps schedule and expedite delivery of ordered items in conjunction with maintenance department requirements.
• Together with maintenance team identifies and purchase (critical) parts
• Identifies gaps and provides content improvements to Preventative Maintenance procedures and frequency of execution using lean methodologies
• Manages the inventory of the stockroom and ensures parts are readily available
• Prepares & kits parts required for Maintenance Workorders
• Maintains accurate records/documentation i.e. batch certificates for parts and equipment.
• Lead issuance and management of maintenance and calibration Purchase Orders.
• Maintain Spares in the Computerized Maintenance Management System (CMMS).
• Responsible for producing monthly management reporting, data analysis and KPI reporting to Facilities management.
• Performs scheduled Cycle counts of the stockrooms
• Ability to develop solutions to moderately non-routine problems.
• Vendor management skills related to facilities and maintenance.

Qualifications:

• Bachelor's degree and 8 years of maintenance industry experience, or 2-year degree in technical discipline and 10 years of applicable experience. Flexibility given with applicable and technical expertise.
• Experience working in facilities subject to GMP regulatory compliance, required.
• Superb organizational skills, attention to detail and error-proofing habits
• Experience in biopharmaceutical industry, preferred.
• Demonstrated experience working with mechanical, electrical, instrumentation and control systems.
• Experience working with cross functional teams.

• Experience working with and administering Computerized Maintenance Management Systems (CMMS) g. Maximo, Blue Mountain, SAP or similar

• Experience working with process equipment (Drug Substance Manufacturing) and laboratory equipment, product use, and terminology, preferred.
• Ability to work independently possessing strength in organizing work and time management.
• Demonstrated ability to provide written and oral summaries of work.
• Proficiency in working standard office applications such as Microsoft Word, PowerPoint and Excel
• Ability to handle competing priorities, projects, as well as urgent situations
• Ability to read and understand electrical, mechanical and pneumatic drawings and equipment manuals.
• Excellent attention to detail and documentation.
• Ability and willingness for on-call and after-hours emergencies response.
• Ability to stand and walk throughout scheduled work shift, ability to lift and or move up to 50lbs, work in tight, low or elevated positions.

Reporting Structure:

This position has management responsibilities, and reports to Sr. Director of Facilities and Engineering.

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

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