(Senior) Manager, Product Development

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa’s clinical pipeline derives from  two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.

Job Position
(Senior) Manager, Product Development

 Job Description

This role is responsible for coordinating outsourced works and assisting all members of Product Development in aligning their product development activities with corporate goals and priorities, project timelines and budgets. He/she tracks and documents scientific progress of both internal and external projects, monitors scope, status, schedule and budget, and he/she also follows up closely with stakeholders to ensure that projects are on track. This position establishes timely and efficient communication for sharing operational updates of Product Development activities with Project teams and Project Managers, and ensuring problems are rapidly identified and resolved to deliver on commitments.

Responsibilities

  • Provide administrative and logistic support for all Product Development activities in the department
  • Responsible for department’s and Projects’ budgets, activity tracking, and setup and maintenance of a documentation system for efficient information sharing
  • Work with scientists and directors to file development reports to document all completed activities and serve as the key person to manage a retrievable report system
  • Assist department members in sourcing and procuring materials or technologies by conducting suppliers and/or capability survey, initiate contact and track projects progress with relevant external parties and keep up with new industrial trends for Product Development of Cell Therapies
  • Supports Product Development outsourced work as well as assay technology transfers by establishing contracts and scopes management with contract research organizations, contract development and manufacturers, service/supply vendors.
  • Ensure communications for Product Development activities and progress with Tessa colleagues is effective and transparent, with timely updates on critical tasks to project managers to help them update project timelines accurately
  • Develop and maintain positive relationships with collaboration partners ensuring positive team environment and alignment with Tessa’s strategies
  • Collaborate with QA and Regulatory Affairs departments to ensure GxP data quality and timely records retrieval in accordance to Tessa’s Quality Policies
  • Flag potential quality problems and communicate any deviations and escalate issues as appropriate
  • Participate in future hiring and resource planning for Product Development department

Requirements

  • Bachelor’s degree in Life Sciences
  • More than 10 years track record in managing multiple projects in life science industry
  • Data analysis skills using basic statistics are required.
  • Basic knowledge of GMP, GCP, and CMC & QA guidelines are highly desired.
  • PMP certification or with strong project management skills desired
  • Highly developed inter-personal skills and verbal/written communication
  • Strong problem solving and critical thinking skills
  • Ability to manage situations with internal and external collaborations and help teams focus on making progress through objective and clear communication style