Senior Manager/ Associate Director, Manufacturing (Drug Product Sterile Filling)

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/ Associate Director, Manufacturing (Drug Product Sterile Filling)

Overview

As a Manufacturing Associate Director/Senior Manager in a growing and dynamic team, you will use your passion, creativity and diverse industry experience to provide leadership and direction to the Fill/ Finish team on the manufacturing floor. You will lead and guide the team to ensure excellent standards of manufacturability, cleanroom operational efficiency, yield improvement, failure analysis, while identifying opportunities for continuous improvement. You will also collaborate with other multi-disciplinary teams to maintain strong functional relationship and working closely to meet the overall Technical Operations and site’s strategic goals and objectives.

With your passion in people management and focus on collective interest, you will guide, develop and mentor your fellow colleagues to ensure a highly collaborative, professional and high performing team that will deliver excellent results while establishing a positive and high energy workplace environment.

Job Description

Manufacturing Operations

  • Direct and manage all fill and finish operations on the manufacturing floor.
  • Provide technical leadership for aseptic manufacturing operations.
  • Management and planning of manufacturing activities, namely – (1) schedule and capacity planning, (2) execution and maintenance of manufacturing processes and operations, (3) oversee and review batch records and (4) efficient allocation of manpower and resources.
  • Lead investigations and change management relating to manufacturing processes, namely – (1) author deviation and non-conformance reports (when required), (2) conduct thoughtful and meaningful RCA and CAPA relating to deviation, (3) author change controls and drive the execution of change plans (as required).
  • In partnership with Quality, develop and maintain a robust quality and compliance culture and performance that meet applicable GMP regulatory standards and supports regulatory inspections.
  • Review, approve and author (when needed) of GMP document such as SOPs, Batch Record, Investigation Reports related to the Fill & Finish Operations.
  • Participate and support the technology transfer of the process to the Fill & Finish Facility which will also include documentation readiness, facility readiness and operational readiness.
  • E  stablish and maintain a safety-first culture. Drive manufacturing related workplace Health, Safety, and Wellness (including ergonomics) initiatives together with the in-house EHS representatives.
  • Drive and seek continuous improvement of all processes and workflows to achieve stable, lean and efficient manufacturing and business processes.
  • Collaborate and work effectively with other departments to achieve the overall goals for Technical Operations.

Strategy, Planning and Business Development

  • Develop manufacturing operations strategy in collaboration with cross functional teams to achieve objectives that are aligned with the site’s strategic directions.
  • Develop, plan and implement manufacturing operations and business processes for new facility start-up. SOPs, workflow and processes shall be critically thought out to cater for all aspects of fill finish operations.
  • Jointly lead and drive execution of commissioning, qualification, and validation activities for the site with Validation team.
  • Establish the required processes and communications to enable cross functional teams to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement on the shop floor.
  • Responsible for developing and monitoring of budgets for manufacturing related operations, labour and capital expenditures to ensure effective use and allocation of financial resources to meet operational objectives.

Manpower and People Development

  • Plan and identify required resources and expertise and appropriate team/departmental structures.
  • Attract, hire, and develop key talent to the organization per the site’s workforce plan.
  • People development and management, including – (1) recruitment and talent development, (2) developing supervisors and team leaders, (3) provide mentorship, (4) carry out performance review, and (5) ensure team succession and Business Continuity Plans (BCP).

Requirements

  • Bachelors, Masters, or PhD in Life Science/ Biomedical Sciences/ Chemical Engineering / Bioengineering/ Bio-processing and other relevant scientific or engineering disciplines.
  • >9 years of GMP biopharmaceutical manufacturing experience.
  • At least 3 years of leadership and managerial experience with track record of building and leading exceptional teams.
  • Extensive experience in GMP cleanroom operations and aseptic operations is mandatory.
  • Strong working knowledge of cGMP guidelines and relevant regulatory knowledge (HSA, FDA, EMA, PICS).
  • Strong Technical writing skills for the authorship of internal/external documents and approve technical documents.
  • Highly skilled in applying Root Cause Analysis tools and in designing meaningful CAPAs.
  • Highly proficient with Microsoft Office Suite and able to efficiently utilise MS Excel, MS Word, or MS PowerPoint for presentation and management reporting.
  • Excellent communication and presentation skills. Able to communicate ideas, problem statements and plans clearly and effectively for decision-making / determination of path forward. Communication should be relatable and factor in perspectives and interests of a multi-disciplinary group.
  • Team player with strong work ethic and thrives in intellectual challenges.
  • Strong interpersonal skills and ability to develop important relationships with key stakeholders, good conflict management and negotiation skills.
  • Excellent critical thinking and problem-solving skills. Able to critical assess situations and approach solving problems with first principles.
  • Outstanding organisation and time management skills with demonstrated ability to manage and prioritise multiple tasks and projects.
  • Highly motivated and self-driven with proven track record of delivering complex projects and working with multi-disciplinary teams.