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Engineer, Ms&T (Manufacturing Science & Technology)

Employer
Molecular Templates, Inc.
Location
Austin, TX
Start date
Jul 21, 2022

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Job Details

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:

 

 

Molecular Templates is seeking an experienced professional to play a key role within technical operations at our GMP manufacturing facility. This Engineer is a Subject Matter Expert (SME) with the demonstrated knowledge and understanding of scientific concepts, practices, and procedures within a cGMP environment. 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:

 

 

  • Facilitate and support technology transfers from Process Development into Manufacturing.
  • Execute technical and scientific projects including study plan and execution, writing technical reports, data analysis and interpretation to support development and manufacturing activities.
  • Ensure quality and effectiveness of key results of major projects through sound design, early risk assessments, and implementation of fall-back strategies to mitigate risk.
  • Conduct study protocols, data analysis, reports, and standard operating procedures (SOPs) that support development and manufacturing activities.
  • Author investigations, CAPAs, SOPs, change controls, batch records, and product impact assessments as required to support GMP operations.
  • Provide troubleshooting support on process-related technical issues in upstream, downstream, fill/finish, and various analytical methods.
  • Respond technically for quality system responsibilities: process-related investigations; product impact assessments; change control assessments; CAPA assessments, etc.
  • Execute studies and reports relating to process understanding, characterization, validation, and conducting validation of manufacturing and test methods.
  • Participate as a technical expert in site regulatory inspections as needed.
  • Support CMC sections of regulatory filings.

 

Qualifications:

 

  • Bachelors' Degree in Chemical/Biochemical Engineering or equivalent, with a minimum three (3) years of relevant experience is required. Master’s degree is preferred.
  • Solid understanding of upstream, downstream, and/or fill/finish processes for biopharmaceutical products is required.
  • Knowledge of safety principles, regulatory requirements, and quality systems is required.
  • Prior experience in process development, technology transfer, scale-up, and process validation activities is required.
  • Experience in facilitating and authoring risk assessments for biologics projects is required.
  • Familiarity with Design of Experiments, Statistical Process Control, Measurement System Analysis, Stability Analysis, Regression Analysis, etc. is preferred.
  • Prior experience successfully participating in cross-functional teams where personal and team accountability, attention to detail, collaboration, and business results were expected is required.
  • Demonstrated ability 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.

 

Reporting Structure:

 

This position currently has no supervisory responsibilities. This position reports to the Sr. Manager, MS&T.

 

 

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

Company

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.  

OWNERSHIP: Public

STOCK SYMBOL: MTEM

STOCK EXCHANGE: NASDAQ

Company info
Website
Phone
512-869-1555
Location
9301 Amberglen Blvd, Ste 100
Austin
TX
78729
US

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