Biosample Operations (Lab Manager), Translational & Early 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:

MTEM is recruiting an individual to manage several types of biosamples collected during and reagents supporting preclinical and clinical efforts for the Translational and Early Development team. This individual will be the interface between internal colleagues and external partners in support of these efforts. Applicant must be able to handle a dynamic and fluid environment in support of efforts to bring new therapies to patients. This role will employ operational and logistical strategies pertaining to sample management to ensure clinical trials are executed with quality and efficiency.

Job Responsibilities will include:

• Manage clinical PK, PD, and biomarker samples between the central laboratory and testing facilities as well as managing external laboratories supporting these efforts
• Engage with Scientists, Project Managers, cross-functional partners, and laboratory vendors to ensure timely and smooth collection, transfer, and testing of clinical trial biospecimens in compliance with protocols, regulatory requirements, and timelines
• Collaborate with MTEM Clinical Operations colleagues regarding designated biosamples
• Manage on-site storage of preclinical samples with routine inventory reviews
• Manage storage and resupply of reagents used to support preclinical and clinical efforts, including, but not limited to, custom monoclonal antibodies
• Coordinate agreements between MTEM and external vendors in support of these efforts
• Establish, design and maintain a sample management LIMS system including management of clinical sample receipt, storage, and retrieval
• Review and provide feedback on clinical study protocols, laboratory documents, and service provider laboratory scope of work documents for sample handling details, to name a few possible documents
• Consistent evaluation of improvement to processes
• Apply and adhere to ICH/GCP, biostorage procedures, bio-sample management best practices and ethical guidelines
• Spearhead sample management process improvement initiatives or improve efficiency as needed, as well as create instructions and manuals for internal training purposes

Qualifications:

• Bachelor's degree in Biochemistry, Chemistry, Biology, or a related field, required. Master's preferred.
• Minimum of 8 years biosample management experience, preferred, may be replaced with a Master's Degree in a relevant field
• Scientific background and knowledge of oncology is desirable
• Expertise in MS Office applications including Excel, Word, and PowerPoint
• Technical knowledge to maintain electronic files and experience with database entry (e.g. LIMS) is preferred
• Demonstrated experience in mastering new software
• Superb organization, planning, and time management skills
• Excellent oral and written communication skills in English
• Initiative and self-motivation are required
• Flexibility and resilience are required
• Ability to work with minimal supervision

Reporting Structure: This position has no supervisory responsibilities. This position reports to Senior Scientist, Non-Clinical Development.

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

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