Stability Associate, Quality Control

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 an experienced QC Stability Associate to join our Quality Department. The Stability Associate will primarily support initiation and execution of stability protocols, management of the onsite Stability Inventory, process incoming and outgoing stability samples, data entry, review of data trends, and assist the Stability Coordinator in other activities related to the stability program. The successful stability associate will have excellent organizational and time-management skills, verbal, and written communication skills, plus an ability to apply attention to detail.

Job Responsibilities will include:

• Manage onsite Stability Inventory
• Process outgoing samples to CROs
• Input stability data and review data for trends to support reports to management, such as annual product review
• Complete input of all backlogged data into Stability database
• Build studies in database
• Generate process related metrics, monitoring for efficiency
• Assist in generation and closure of stability-related deviations, change controls and CAPAs
• Provide support for regulatory filings, audits, and inspections
• Support Data Review group to inventory and manage completed data packets, as needed
• Assist in QC stability testing, as needed

Qualifications:

• Bachelor's degree from accredited institution in a scientific discipline, preferred
• A minimum 2 years' experience in GMP laboratory environment (analytical/chemistry), required
• Experience in biopharmaceutical industry, preferred
• Demonstrated knowledge of cGMP regulations, quality systems and regulatory requirements
• Excellent project management, time management, and multi-tasking skills
• Excellent written and verbal communication skills
• Excellent computer skills with knowledge of Microsoft Suite including Excel, Word and statistical analysis software
• Ability to manage competing priorities or projects
• Ability to work under supervision and/or function independently, exercise good judgement and work in a team-based environment
• Ability to identify problems and solutions then act to resolve
• Demonstrated ability to resolve operational and strategic issues
• Ability to apply attention to detail as applied to data review and compliance
• High degree of reliability and professionalism

Reporting Structure:

This position has no supervisory responsibilities. This position reports to the QC Stability Coordinator.

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

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