Senior Manager, Manufacturing Technology

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 ETB 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:

We are seeking a highly skilled and highly motivated professional to lead GMP technical operations within Manufacturing. This role will manage and oversee manufacturing readiness and compliance activities as it relates to receipt of tech transferred molecules, implementation of new technology, and closure of quality events within GMP Manufacturing. This position will ensure the effective use of materials, equipment, and employees in producing quality products, recommend and author manufacturing policies and procedures, prepare documentation, reports, and SOPs as required, and select, train, and evaluate personnel to ensure efficient operations.

Also, this position will work closely with Quality, Engineering, 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:

• Manage the Manufacturing Technology team, responsible for manufacturing readiness and compliance related activities.
• Provide oversight of the Compliance team focused on authoring, reviewing, and approving investigations, CAPAs, SOPs, change controls, and batch records
• Lead cross-functional risk assessments, facility fit assessments, continuous improvement projects and other manufacturing readiness activities 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 Process Development to enable receipt of tech transfer and scale-up for new or modified biological processes
• 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
• Identify and assist in introduction of new technologies and new equipment into GMP Manufacturing.
• Support manufacturing operations and ensure compliance with current corporate policies, regulatory guidelines, and safety practices
• Provide troubleshooting for process equipment and manufacturing operations as needed Responsible for interacting with external vendors for equipment and automation support
• Identify and implement process improvements, particularly for optimization, efficiency, and growth
• Review and approve single-use consumable drawings required for GMP manufacturing
• Author, review and/or approve investigations, CAPAs, SOPs, change controls, and batch records as required to support GMP operations
• Recruit, hire and develop a high-performing team. Provide supervision and training to direct reports.
• Actively participate in an environment which fosters safety, quality, and continuous improvement

Qualifications:

• B.S. in the Biological Sciences, Chemical/Biochemical Engineering, or related field with seven (7) years relevant experience, and master’s degree preferred.
• Manager Level: Minimum of 4 years of relevant experience within a GMP manufacturing environment, a clean room environment, or a highly regulated environment is required (7+ years is preferred).
• Sr. Manager Level: Minimum of 6 years of relevant experience within a GMP manufacturing environment, a clean room environment, or a highly regulated environment is required (8+ years is preferred).
• Previous experience managing others, required.
• Experience working in a cGMP environment, required
• Demonstrated experience leading cross-functional teams
• Expert level experience and with fermentation and protein purification operations as well as with operation of manufacturing process equipment and automation is required.
• Prior experience successfully leading teams where personal and team accountability, attention to detail, collaboration, and business results were expected is required.
• Demonstrated ability to supervise a team, to work under minimal supervision in a team setting as well as prioritize and manage time efficiently.
• Demonstrated ability to problem solve and provide solutions to challenges or obstacles.
• Excellent computer skills and proficiency of Microsoft Office tools (Word, Excel, PowerPoint), Adobe, Teams, SharePoint, Visio, and the ability to learn new systems.
• Ability to understand and exercise advance mathematical calculations and excel formulas.
• Experience with operational excellence tools and methods, preferred.
• Flexible, resourceful, and comfortable working in a fast-paced, complex, dynamic team environment.
• Ability to identify problems and take action to resolve them
• Strong oral and written communication skills
• Excellent organization skills

Reporting Structure:

This position has supervisory responsibilities. This position reports to the Director of GMP 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.

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