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%
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
Telecommuting is allowed. Employer will assist with relocation costs.
Additional Salary Information: Salary, bonus, 401K, and full medical coverage
About Molecular Templates
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