Scientist, Quality Control

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 currently has several ETB candidates in clinical development including MT-3724 and MT-5111. Additional preclinical compounds derived from our ETB platform technology 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 motivated and dynamic professional evaluate and implement protocols and methods. This QC Scientist will develop, implement and perform analysis and identify trends in the inspection of bulk raw materials, in-process materials, finished products and; and recommend corrective action when necessary to determine and maintain appropriate quality control analysis especially in HPLC, CGE and Potency assays. This role will also coordinate and execute testing activities, as well as authoring technical protocols and reports, as applicable. May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, ICH). This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams and contractors.

Job Responsibilities will include:

• Perform feasibility assessment, optimization, and method validation for existing and new methods to support testing and release of Drug Substance and Drug Product.
• Generate GMP documents to support testing of Drug Substance and Drug Product.
• Support the Regulatory Submission process by providing method qualification and validation reports.
• Trend data to provide analysis and potential areas of concern and/or further development.
• Support the development of processes and tests to ensure proper quality control analysis is being performed on raw materials.
• Review third party method qualification and validation documentation.
• Support the cleaning verification program through method qualification and method development.
• Maintain GMP areas to ensure compliance for all requirements for control of materials. This includes cleanliness and organization.
• Support the investigations of deviations and/or out of specifications as necessary related to Quality Control work performed.
• Follow safety guidelines for handling, disposal and use of chemicals and bacterial waste.

Qualifications:

• Advanced degree in the Life Sciences or related field, required
• Minimum of 8 years with MSc or 4 years with PhD of industry experience in pharmaceutical or biotechnology area focused on drug development, GMP quality control, and analytical development experience.
• Experience with protein-based therapeutics, required
• Comprehensive knowledge of cGMP regulation applicable to the FDA and comparable international regulatory agencies
• Demonstrated experience creating analytical development plans and experiment design, generation of test procedures, qualification/validation, and then establishing product specifications and critical quality attributes and limits
• Experience in HPLC, CGE and Potency assays is preferred
• Experience in managing quality systems and program management, required
• Excellent written and verbal communication skills
• Experience in statistical analysis
• Excellent computer skills
• Excellent technical, analytical and problem-solving skills
• Excellent organizational and multi-tasking skills
• 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 currently has no supervisory responsibilities. This position reports to Director, Quality Control.

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

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