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Specialist, Quality Assurance (Systems)

Employer
Molecular Templates, Inc.
Location
Austin, TX, USA
Start date
Feb 24, 2021

View more

Discipline
Clinical, Clinical Medicine, Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Lone Star Bio

Job Details

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 highly-skilled and motivated QA professional to support compliance and monitoring efforts for Quality Assurance. This Specialist primarily will focus on the Batch Record issuance, review, and completion process from assigning the batch record number to reconciliation, initial QA review of Batch Record, verifying completeness and identifying additional required deviations and documentation. This position will be required to work collaboratively and cross-functionally with the Manufacturing, Facility, QC, QA, and Supply Chain to ensure workflow 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:
  • Provides QA support for deviations, laboratory investigations, corrective and preventive actions, and change controls
  • Provides QA review for qualifications and validations of equipment, methods, and processes
  • Identify risk and evaluate deficiencies while working with internal departments/business units to appropriately remedy
  • Facilitate internal training on quality assurance requirements, processes, and procedures
  • May perform internal audits and risk assessments
  • Evaluate procedures for cGMP and other compliance standards
  • Trend data to provide analysis and potential areas of concern to support production efficiencies, continuous process improvement and initiatives
  • Prepare and deliver communications with interpretation of data analysis and potential problems to management
  • Provides support in the review of change controls related to manufacturing, test methods and specifications to meet cGMP and internal standards
  • Collaborate is cross-functional work groups on organization initiatives
  • Write and review Standard Operating Procedures as needed

Qualifications:
  • BS degree, preferably in the Life Sciences or related field
  • Minimum of seven (7) years of industry experience in biopharmaceutical or biotechnology regulated environment, preferably in manufacturing or quality role
  • Knowledge and experience with cGMP manufacturing, quality, and compliance
  • Skilled in data analysis and problem solving
  • Must be action-oriented and customer-focused and skilled in building relationships, problem solving, planning and organizing and analytical thinking
  • Ability to complete tasks with minimal supervision
  • Demonstrated ability to recognize Quality issues and takes on role as problem solver
  • Skill in providing input within the department and in cross functional teams
  • Ability to write and review reports with clarity and brevity
  • Demonstrated competence in quality processes, including change control, deviations and CAPA management
  • Excellent verbal and written communication skills
  • Ability to multitask in a fast-paced environment
  • Possesses strong authorship and ability to critically review investigations, interpret results and generate technical conclusions.

Reporting Structure:

This position has no supervisory responsibilities. This position reports to Manager, Quality Assurance.

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

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

Company

Molecular Templates, Inc. (MTEM) is a clinical stage biopharmaceutical company focused on the discovery and development of biologic therapeutics for the treatment of cancer and other serious diseases. The company primarily develops a pipeline of therapies through its proprietary biologic engineered toxin body (ETB) drug platform with unique mechanisms of actions which are highly differentiated from antibody drug conjugates (ADCs). MTEM is developing MT-6402, which is in a Phase I clinical trial for PD-1/PD-L1 antibody relapsed/refractory patients; MT-5111, which is in a Phase I clinical trial for the treatment of HER2-positive cancers; and MT-0169, which is in a Phase I clinical trial to treat relapsed/refractory myeloma. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development.  Additional information about MTEM can be obtained at www.mtem.com.  

OWNERSHIP: Public

STOCK SYMBOL: MTEM

STOCK EXCHANGE: NASDAQ

Company info
Website
Phone
512-869-1555
Location
9301 Amberglen Blvd, Ste 100
Austin
TX
78729
US

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