Scientist, Analytical Development (QC)
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.
Molecular Templates is seeking a highly-skilled and dynamic professional to contribute to method qualification and validation protocols and reports to support Quality Control and Manufacturing Development, Production testing, and regulatory filings. This Scientist will develop and optimize analytical methodology to test the identity, strength, purity, potency and stability of protein products (in-process and final). This role will assist with data analysis, 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:
- Perform and contribute to feasibility assessment, optimization, and method validation for existing and new methods to support testing and release of Drug Substance and Drug Product.
- Manage GMP documents to support testing of Drug Substance and Drug Product.
- Provide support to regulatory submission process by generating method qualification and validation reports.
- Trend data to provide analysis and potential areas of concern and/or further development.
- Design and develop processes and tests to ensure proper quality control analysis is being performed on raw, in-process and final materials.
- Review third party method qualification and validation documentation.
- Support the cleaning verification program through method qualification and method development.
- Ensure compliance for all requirements for control of materials.
- Investigate any deviation or out of specification as necessary related to Quality Control.
- Follow safety guidelines for handling, disposal and use of chemicals and bacterial waste.
- MS degree plus 2+ years of relevant industry experience; or PhD degree in Life Sciences, Chemical Engineering, Biochemical Engineering, Biochemistry.
- Minimum of two (2) years of industry experience in pharmaceutical or biotechnology area focused performing analytical development for Quality Control and Manufacturing Development
- Comprehensive knowledge of cGMP regulation applicable to the FDA and comparable international regulatory agencies
- Experience with protein-based therapeutics, required
- 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 managing quality systems and program management, required
- Excellent written and verbal communication skills
- Excellent computer skills
- Excellent technical, analytical and problem-solving skills
- Excellent organizational and multi-tasking skills
- Ability to provide thought-leadership and scientific insight for method development, data analysis and other GMP QC activities
- 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
This position currently has no supervisory responsibilities. This position reports to Manager, Analytical Development (QC).
Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.
Molecular Templates Inc https://mtem.isolvedhire.com