Sr. Scientist/Scientist, Bioassay Development

Location
Austin, TX, USA
Posted
Nov 01, 2020
Ref
200704
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 a Senior Scientist to develop and qualify bioassays for determination of the potency of Engineered Toxin Body (ETB) therapeutics, for drug substance, drug product release, stability, and product characterization. The Senior Scientist must be experienced in cell-based assay development and capable of determining the root cause of potency assay variability and providing solutions to reduce variability and improve performance precision. The Senior Scientist must be familiar with handling cell lines used for bioassays and possess significant knowledge of reagents and detection systems that will provide strong signaling for dose response profiles. This position requires someone with significant experience in development of functional in vitro cell-based bioassays that are closely representative of the mechanism of action of ETB therapeutics in clinical use. The Senior Scientist will work closely with R&D in selection of cell lines expressing antigens targeted by the ETBs and which perform well under potency assay conditions. The Senior Scientist will work closely with Quality to develop and deliver protocols for potency assay validation.

Job Responsibilities will include:
  • Primary responsibilities are focused on, but not limited to, cell-based potency and functional assays
  • Support selection of high performing potency assay cell lines, manage and maintain cell lines used in potency assay execution
  • 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
  • Investigate any deviation or out of specification as necessary
  • Follow safety guidelines for handling, disposal and use of chemicals and bacterial waste


Qualifications:
  • PhD degree in Cell Biology, Immunology, Molecular Biology or similar field, highly preferred
  • Scientist requires a minimum of 2+ years of relevant industry experience
  • Exceptional non-PhDs with equivalent experience and demonstrated capabilities in the biotechnology or pharmaceutical industries may also be considered; Post-doctoral work may serve as experience
  • Working experience in analytical development and/or GMP testing with primary focus on the development, tech transfer and qualification/validation of bioassays (including, but not limited to cell-based potency methods is essential development is preferred.
  • Hands-on experience in flow cytometry and fluorescence-based plate reader is required
  • 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
  • Excellent written and verbal communication skills
  • 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 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, Analytical Development.

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

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