Principle Scientist - Product Attributes Team Leader

Location
Austin, TX, USA
Posted
Feb 23, 2021
Ref
239958
Hotbed
Lone Star Bio
Required Education
Bachelors Degree
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 an experienced and dynamic professional to lead and direct biopharmaceutical CMC activities for new and advanced products. This role requires knowledge and experience in the preparation of CMC regulatory submissions, response to agency questions, comments, IND updates, annual reports, and regulatory agency requirements for early and late product development phases.

This Product Attributes Team Leader will provide guidance and support to internal groups such as biopharmaceutical process and product development, attribute sciences, formulation development quality, manufacturing, supply chain and regulatory affairs. This leadership role will extend to outside groups, such as contract manufacturing organizations and contract laboratories by overseeing services for production of drug substance and drug product, and analytical characterization studies. This role will be responsible for conducting product quality risk assessments and manage preparation of CMC regulatory submissions. This position will require excellent technical knowledge in biopharmaceutical drug substance and drug product development, analytical development, demonstration of sound decision making and problem-solving skills, along with ability to operate independently, collaborate with cross-functional teams, contractors, and external regulatory agencies.

Job Responsibilities will include:
  • Interact with biopharmaceutical development, quality, manufacturing in the production, release, stability of drug substance and drug product to monitor and trend data for intermediates and final materials
  • Coordinate upstream, downstream, analytical and drug product development activities required for CMC regulatory submissions
  • Work with Operations functions within CMC in defining specifications from trending and analyzing batch and stability data
  • Execute Product Quality Risk Assessments (PQRAs), plan and oversee studies to fill data gaps with potential impact on product safety and biological performance
  • Coordinate all internal and external CMC activities required for regulatory filings
  • Prepare and review CMC modules for development and registration applications, annual reports, amendments, and supplements for submission, ensuring CMC content meets current FDA/Health Authority requirements
  • Provide templates for Biopharmaceutical Development to prepare excerpts of development reports that are regulatory-filing-ready for abstraction into CMC modules
  • Track and deliver CMC regulatory responses and commitments according to agreed timeline
  • Execute QC release and stability data verification
  • Interface with internal Regulatory Affairs CMC for regulatory filing submissions
  • Maintain internal and external CMC data and reports
  • Serve as a CMC project contact with external and internal clients

Qualifications:
  • Advanced degree in the Life Sciences or related field, required
  • Minimum of eight (8) years of relevant experience in pharmaceutical, biotechnology or a related industry focused on drug development
  • Experience with biological process development, analytical, formulation and drug product development
  • Demonstrated experience with large molecule biologics and minimum two (2) years directly involved with CMC operations
  • Experience in process and analytical development, qualification, and validation
  • Excellent written and verbal communication skills
  • Excellent computer skills
  • Excellent analytical skills and problem-solving 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
  • Minimal travel required


Reporting Structure:

This position currently has no supervisory responsibilities and reports to the head of Product Attributes Sciences.

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

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