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Sr. Scientist, Formulation Development

Company: Molecular Templates, Inc.
Location: Austin
Posted on: November 12, 2019

Job Description:

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 . Position Overview:The Senior Scientist, Formulation Development will help lead biologic Drug Substance and Drug Product formulations development for Molecular Templates platform engineered toxin bodies platform. Formulation development responsibilities includes design of experiments, study execution, report summary, assessment and selection of desirable formulations. This position will closely coordinate studies and deliverables with Analytical development, Process Development/Sciences and CMC, both internally and externally with molecule partners. Development, scale-up and technical transfer of formulations for biologic products range from pre-clinical to Ph I clinical trials through manufacturing process performance qualification, license application and commercialization.Job Responsibilities will include:

  • Proactively drive the formulation and process development of parenteral formulations
  • Use innovative and modern techniques to develop and characterize dosage forms with appropriate stability profiles and develop associated manufacturing processes to meet project needs
  • Generate data to be utilized to nominate dosage forms, support clinical trial applications, scale-up and enable transfer of manufacturing processes, and to support product licensure-related activities in accordance with ICH guideline - Q8 and Q9
  • Author written reports which support regulatory filings associated with his/her work, and participate in technology transfer activities to manufacturing sites
  • Independently plan, perform and document scientific experiments and extract as well as communicate relevant findings in reports and presentations
  • Interact effectively with a multidisciplinary team of scientists and engineers for formulation and process optimization and overall product development
  • Communicate and collaborate cross functionally with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams
  • Drive development of business practices and continuous improvement thereof, including feedback from relevant stakeholders Qualifications:
    • PhD in a relevant area of specialization (process engineering, analytical chemistry, protein chemistry, biochemical engineering, biological sciences, or biochemistry), plus 3+ years of experience in life sciences including 1+ years in an formulation development role. Ideally, 3+ years bio/pharma experience in a similar role is preferred. Exceptional MSc candidates with 5+ years, or BSc candidates with 8+ years, working experience in the life sciences will also be considered.
    • Knowledge of the biophysical/biochemical analytical methods relevant for protein therapeutics
    • Extensive experience in formulation development and methods used to characterize proteins such as: CE-SDS, CZE, SC, IEC, HIC, RP-HPL iCIEF, MALS, DLS, DSF, AF4, LC-MS/MS, AUC, ELISA, SDS-PAGE, UV-Vis spectrophotometry and BCA/Bradford
    • Statistical knowledge and experience e.g. capability analysis or design of experiments (DOE) methodologies
    • Demonstrated experience in writing developmental and technical reports and contributing to regulatory submission
    • Strong verbal and written communication skills and effective interpersonal, technical discretion and troubleshooting skills are essential
    • Strong attention to detail supported by excellent time management and organizational skills
    • Must be a team player and strong critical thinker
    • Ability and willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines
    • Demonstrated history of working independently, with minimal supervision, and managing multiple projects
    • Proficient or familiar with Microsoft based Windows programs: Word, Excel and Powerpoint as well as analytical software such as Empower or Softmax Pro and statistical software such as GraphPad, Minitab, JMP or Spotfire Reporting Structure:This position currently has no supervisory responsibilities. This position reports to Formulation Manager, Process Sciences.Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.Molecular Templates Inc

Keywords: Molecular Templates, Inc., Austin , Sr. Scientist, Formulation Development, Other , Austin, Texas

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