Senior Scientist, Upstream Process Development

Company Description:

Molecular Templates (Nasdaq: MTEM) is a clinical-stage company focused on the discovery and development of targeted biologic therapeutics. Molecular Templates' proprietary 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 several drug candidates in various stages of clinical and preclinical development including MT-3724 (CD20), MT-5111 (HER2), and TAK-169 (CD38) which is being developed in partnership with Takeda Pharmaceuticals. For more information, please visit MTEM's website at www.mtem.com.

Position Overview:

Molecular Templates is seeking an experienced and dynamic professional to design and scale-up fermentation processes from the laboratory through pilot plant and manufacturing, help identify and evaluate new process technology for improved process quality, yield, and robustness, and evaluate novel expression systems for performance under scale-relevant fermentation conditions. In addition, this individual will provide technical leadership to a growing team of scientists, development associates, and technicians in the field of fermentation process development and science, and will serve as an Upstream Subject Matter Expert in both internal and external technology transfer.

Job Responsibilities will include:

• Design, execute and analyze robust and scalable fermentation development projects independently, using scientific and engineering principles
• Design upstream processes using scientific and engineering principles
• 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
• Function as upstream SME to transfer technology to internal and external manufacturing partners
• Plan and implement the development of new process formulas
• Establish operation equipment specifications and improve manufacturing techniques
• Design, manage and support process characterization studies and develop control strategies for process validation
• Work effectively with team members and contractors both in-person and remotely. Provide direction, support, and corrective action as needed.
• Ensures that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
• Provide leadership and direction to junior colleagues in the field of fermentation process development
• May require travel up to 15%

Qualifications:

• PhD in Chemical Engineering, Microbiology or closely related field plus 4+ years' experience in microbial fermentation process development, or a M.S plus 7+ years' experience
• Strong background in statistically designed experiments (DoE) required
• Experience in tech transfer of a process from development to manufacturing and between manufacturing sites
• Cell line development experience preferred
• Downstream processing experience preferred
• Biopharmaceutical experience strongly preferred
• Outstanding knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
• 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
• Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports

Reporting Structure:

This position currently does not have supervisory responsibilities. This position reports to Director, Upstream Development

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

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