Sr. Scientist, Downstream Process Development

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 www.mtem.com.

Position Overview:

Molecular Templates is seeking a highly-skilled and motivated professional to support downstream process development. The Senior Scientist will be responsible for developing robust, efficient and scalable downstream processes for the manufacture of recombinant biologics. This includes experimental design, execution, analysis and report authoring of process development activities like cell lysis, various clarification methods, filtration, chromatography, ultrafiltration, diafiltration, formulation and vialing. The Senior Scientist will be responsible for leading a small project team of one to two associates, and will be responsible for delegating activities and ensuring the team's proper execution of experiments. Additional activities will include solution preparation, equipment maintenance and calibration, data management, report authoring, review of manufacturing processes and identification of continuous process improvement opportunities. This includes new product scale-up, purification, process optimization, technology transfer and process 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 and lead a small team on progressively more complex activities and projects.

Job Responsibilities will include:

• Leadership of a small team of one to two associates in downstream development activities
• Develop downstream processes for biologic manufacturing activities. This includes, but not limited to, buffer and solution preparation, various filtration methods, centrifugation, chromatography, column packing and packed bed qualification, various sterilization methods, vialing and labeling, process data recording and trending
• Conduct testing of new process formulas, technologies and products, including but not limited to new product scale-up, process optimization, limited characterization of protein products, impurities, and protein purification 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 advance 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
• Maintain detailed experimental records. Complete required documentation in an accurate and timely manner, adhering to written procedures and regulatory requirements
• Pre-clinical manufacture (lab scale) of biologics for animal studies.
• Support downstream manufacturing investigations through scale-down studies and experimental investigations.
• Author technical reports for internal review.
• Perform other duties and special projects, as needed

Qualifications:

• MS degree plus 4+ years of relevant biopharmaceutical industry experience in downstream processing/process development of biologics; or PhD plus 2+ years of relevant biopharmaceutical industry experience in downstream processing/process development of biologics. Degree emphasis in Life Sciences, Chemical Engineering, Biochemical Engineering, Biochemistry
• Demonstrated technical proficiency in protein purification
• Experience in developing and designing downstream processes, required
• 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 work in a fast-paced, high-growth work environment
• Ability to identify problems and solutions then take action to resolve
• Ability to lift 30 lbs. and must be able to stand, crouch, sit, bend, or stretch for extended periods of time
• Must possess flexibility to work varying schedules to support operations, such as occasional 12-hour shift or night shift

Reporting Structure:

This position currently has supervisory responsibilities. This position reports to Manager, Downstream Development.

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

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