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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 Companies. Additional information about Molecular Templates can be obtained at Company website.
Molecular Templates is seeking a highly-skilled and dynamic professional to lead statistical analysis for Quality Control, Manufacturing Development, Production and regulatory filings. This Manager will evaluate the stability program data to support specification development and analysis. This role will also author and review technical protocols and reports, as applicable. May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma). This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams, vendors and contractors.
Job Responsibilities will include:
Evaluate statistical data of ongoing stability testing
Review method developments, qualifications, and validations for statistical analysis
Analyze statistical data to support specification development and analysis
Analyze in-process and completed manufacturing data to support long term manufacturing process improvement and scale up activities.
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