Compliance Specialist, GMP Manufacturing

Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.  

Position Overview:

Molecular Templates is seeking a highly-skilled and motivated professional to support cGMP process and documentation efforts for production. This Specialist will support

compliance and ongoing preparation, testing and monitoring of conformance to established cGMP processes and standards for manufacturing and production. Primarily, this role will focus on compilation and review of Batch Record, SMP and Material forms, verifying completeness and identifying entry errors, omissions, missing data and GDP corrections. This role will be first-line is issuance if corrections and deviations and will require close collaboration with Manufacturing, QC and QA, Supply Chain and Warehouse to ensure work flow and compliance standards. This position will require technical knowledge of bioprocesses, attention to detail, organizational skills, along with ability to operate independently, collaborate with cross-functional teams and manage competing priorities and timelines.

Job Responsibilities will include:

• Compile and review Batch Record, Solution Manufacturing Procedure (SMP) and Material firms (TSE/BSE)
• Evaluate procedures for cGMP and other compliance standards
• Investigate and identify root causes and provide corrective action

• Trend data to provide analysis and potential areas of concern to support production efficiencies, continuous process improvement and initiatives
• Provide response to internal and external audits

Qualifications:

• BS degree in the Life Sciences or related field, required
• Minimum of four (4) years of industry experience in biopharmaceutical or biotechnology regulated environment, preferably in manufacturing or quality role
• Comprehensive knowledge of cGMP regulation applicable to the FDA and comparable international regulatory agencies

• Demonstrated experience in managing quality systems
• Experience with protein-based therapeutics, preferred
• Excellent written and verbal communication skills
• Excellent computer skills
• Excellent technical, analytical and problem-solving skills
• Excellent organizational, project management and multi-tasking skills
• Ability to apply basic scientific knowledge and regulatory principles
• Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment
• Ability to work collaboratively with cross-functional teams and contractors in order to drive results and meet company objectives
• Ability to function independently and exercise good judgement, as well as in a team-based environment

Reporting Structure:

This position has no supervisory responsibilities. This position reports to Sr. Manager, GMP Manufacturing.

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

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://mtem.isolvedhire.com/jobs/51200-19034.html