Scientist, Process Sciences (Upstream)

Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB)

platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's

lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.

Position Overview:

Molecular Templates is seeking a highly-skilled and highly-motivated professional to support optimization and transfer of upstream processing for manufacturing activities. The Scientist will be responsible for developing methods for production, including routine fermentation, equipment maintenance checks and calibration, media preparation, data management, and assist in review and testing of new process formulas, technologies and products. This includes new product scale-up, fermentation, process optimization, technology transfer and process characterization/validation activities, as well as developing production procedures and product specifications. This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently on progressively more complex activities and projects.

Job Responsibilities will include:

• Develop methods for protein production and fermentation for upstream manufacturing activities. This includes, but not limited to culture media and solution preparation, various fermentation methods, small (1L) to large (300L) scale fermentation technologies, centrifugation, various sterilization methods, process data recording and trending
• Independent lab work to design experiment, execute experiment, present data review, and write the final report for supporting process development, process characterization and validation.
• Process analysis and support GMP manufacturing as a SME in upstream bioprocess.

• Lead technically for quality system responsibilities: process-related investigations; product impact assessments, change control assessments, CAPA assessments, etc.

• Conduct testing of new process formulas, technologies and products, including but not limited to new product scale-up, process optimization using common laboratory techniques, technology transfer, process validation activities and development of production procedures and product specifications
• Review and revise established protocols and SOPs related to drug development such as process development, data trending, and optimization of techniques. This may also include developing and optimizing assays, conducting limited literature search of research study protocols and reports, regulatory documents, and other potential resources.

• Maintain knowledge of scientific trends industry processes through readings, conferences and seminars; review literature to enhance or improve manufacturing procedures and methods. Use professional concepts and company policies and procedures to solve a wide range of difficult problems in creative and practical ways.
• Complete required documentation in an accurate and timely manner, adhering to written procedures and regulatory requirements
• Perform other duties and special projects including training operators and associates, as needed

Qualifications:

• MS degree plus 4+ years of relevant industry experience; or PhD plus 2+ years of relevant industry experience. Degree emphasis in Life Sciences, Chemical Engineering, Biochemical Engineering, Biochemistry.
• Additional experience may substitute education on a year for year basis
• Demonstrated technical proficiency in microbial fermentation/ cell culture
• Experience in developing and designing upstream processes, required
• Experience in biopharmaceutical industry, required
• Demonstrated success in independent judgment, technical proficiency, scientific creativity, collaboration with others in a cGMP environment
• Excellent written and verbal communication skills
• Excellent computer skills with knowledge of spreadsheet and word processing
• Excellent analytical skills and problem-solving skills
• Excellent organizational, time management, and multi-tasking skills
• Ability to maintain highest standards of accuracy and attention to detail
• Ability to function independently and exercise good judgement, as well as provide thought leadership
• Ability to identify problems and solutions then take action to resolve
• Ability to work well with other technical staffs and scientist/engineers in a collaborative, fast-paced goal-driven environment

Reporting Structure:

This position currently has no supervisory responsibilities. This position reports to Sr. Director, Process Sciences.

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

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