Manager, Product Development

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.

We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

 

Job Position
Manager, Product Development

 Job Description

The position will be based in Tessa’s US Office in Houston, Texas, and is responsible for managing technical progress of the research projects, clinical trial material supply, and monitors GMP production for supporting clinical trials in collaboration with Baylor College of Medicine and other US entities.  This position communicates the operational detail and align the timeline and strategy with Tessa headquarters in Singapore.

Responsibilities

  • Serve as a liaison for the Product Development department with Baylor College of Medicine
  • Collect research and GMP production data and perform data analysis for trending analysis and development history record, and build a database for future technology transfer back to Singapore headquarter or to CMO
  • Provide efficient communication on technical aspects of Baylor collaboration projects, using analyzed GMP and CMC technical data to clearly illustrate key messages
  • Assist in project management and logistic support for scientific and technical aspects of Baylor collaboration projects, from planning, budget, following up contracts, tracking progress, and timeline.
  • Support other US product development projects (e.g., contract research organizations, contract manufacturers, service/supply vendors).
  • Ensure all communications with SG headquarters is effective and transparent, specifically follow-up of ongoing issues, timely updates on GMP production for trials, data collection and tech transfers
  • Collaborate with QA and regulatory affairs departments to ensure GMP data quality and timely records retrieval in accordance to Tessa’s Quality Policies
  • Expected to flag potential quality problems and communicate any deviations and escalate issues as appropriate
  • Develop and maintain positive relationships with collaboration partners ensuring team environment and alignment with Tessa strategic planning
  • Procure critical materials for scientists in Baylor for clinical trials, process optimization, and analytical development
  • Participate in future hiring of this US operation

Requirements

  • Bachelor or Master degree in life science or in business with sufficient course work in life science
  • Data analysis skills using basic statistics are required
  • Minimum 5 years of proven successful track record in life science industry or GMP/GLP regulated laboratories and basic knowledge of GMP, GCP, and CMC & QA guidelines
  • Experience in pharmaceutical drug development, especially in supporting clinical trials, is highly desirable
  • Highly developed inter-personal skills and verbal/written communication
  • Strong problem solving and critical thinking skills
  • Ability to manage situations and motivate colleagues through objective and insightful leadership