Sr. Manufacturing Associate

Molecular Templates, Inc. (MTEM) is a clinical stage biopharmaceutical company focused on the discovery and development of biologic therapeutics for the treatment of cancer and other serious diseases. The company primarily develops a pipeline of therapies through its proprietary biologic engineered toxin body (ETB) drug platform with unique mechanisms of actions which are highly differentiated from antibody drug conjugates (ADCs). MTEM is developing MT-6402, which is in a Phase I clinical trial for PD-1/PD-L1 antibody relapsed/refractory patients; MT-5111, which is in a Phase I clinical trial for the treatment of HER2-positive cancers; and MT-0169, which is in a Phase I clinical trial to treat relapsed/refractory myeloma. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development.  Additional information about MTEM can be obtained at www.mtem.com.

 

 

Position Overview 

 

 

Molecular Templates is seeking an energetic and highly motivated professional to support execution of clinical manufacturing processes for the manufacture of therapeutic proteins. The Sr. Manufacturing Associate will provide on-the-floor execution to bioprocessing unit operations including execution of fermentation and purification steps. This position requires attention to detail, working in a team environment, and interest in learning about bioprocessing operations. The Sr. Manufacturing Associate (second shift)  will be responsible for operating production equipment while adhering to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), and all safety requirements within the clinical-stage biologics manufacturing facility.  

 

 

Job Responsibilities: 

 

 

• Execute fermentation and/or protein purification steps and associated manufacturing activities with minimal direction. Responsible for monitoring the process during the production run
• Proficiently operating a wide range of process, equipment, and troubleshooting technical issues that occur during manufacturing
• Demonstrate a high level of proficiency in process automation and supporting business systems and in the operation of process equipment within an assigned functional area
• Document and verify production steps in accordance with process documents. Review, revise and/or create process documents and assist with process related investigations
• Pro-actively identify, communicate, and offer solutions to technical and operational challenges before they occur. Participate and drive implementation of solutions as assigned
• Maintain the clean room environment to maintain equipment and facility under working order and to comply with safety and regulatory requirements
• Manage multiple tasks or assignments to completion while maintaining high quality, and on-time deliverables
• Follow and adhere to production schedules and timelines
• Work cross-functionally to achieve team goals. Maintain a can-do attitude and foster a positive working environment
• Work with internal and external subject matter experts to implement new technology, equipment, and process improvements. Lead improvement projects across multiple individuals, teams, shifts
• Partner with Quality Assurance personnel to deliver quality product
• Ensure safety, compliance, and Right-First-Time execution

 

 

Qualifications: 

 

• High School diploma, GED, or higher in life sciences, engineering or equivalent experience required. (Associate degree preferred) 
• Minimum of 2 years of relevant experience within a GMP manufacturing environment, a clean room environment, or a highly regulated environment required (4+ years preferred) 
• Applicable knowledge of safety principles, regulatory requirements, and quality systems is required 
• Prior experience and knowledge with fermentation and protein purification operations and equipment is required 
• Prior experience successfully participating in teams where personal accountability, attention to detail, collaboration, and business results were expected is required 
• Excellent documentation skills and attention to detail 
• Proficient computer skills with knowledge of spreadsheet and word processing  
• Demonstrated ability to problem-solve and provide solutions to challenges or obstacles 
• Demonstrated ability to work under minimal supervision in a team setting, prioritize and manage time efficiently with strong problem solving and analytical skills 
• Experience with operational excellence tools and methods, preferred 
• Ability to understand and exercise basic mathematical calculations 
• Ability and interest working in a fast-paced, complex, highly dynamic team environment 
• Ability to lift up to 40lb loads multiple times per shift and carry up to 30 lbs  
• Ability to stand, crouch, sit, bend, or stretch for extended periods of time 
• Ability to work 10 to 12-hour shifts and occasional weekend/holiday work 
• This role is for Day shift 8am-5pm CT

 

 

Reporting Structure: 

 

This position does not have no supervisory responsibilities. This position reports to the GMP Supervisor. 

 

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