Manufacturing Lead (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
Manufacturing Lead (Drug Product Sterile Filling)

Overview

As a Manufacturing Lead, you will use your strong GMP working knowledge and experience to lead and work alongside the manufacturing team to execute Fill/ Finish operations. You will be responsible for planning and driving the execution of manufacturing activities in a cleanroom processing suite, including – providing weekly and monthly activity forecast, planning daily cleanroom activities and ensure the team is focused in execution of these activities.

You will lead and motivate the team to ensure excellence standards of manufacturability, cleanroom operational efficiency while being compliant to GMP requirements. You will foster a highly collaborative, professional, and high performing cleanroom culture that will deliver excellent results while establishing a positive and high energy workplace environment.

During the initial months of the role, you will be involved in the preparation and operational readiness of the new Fill/ Finish Facility.

Job Description

Setting up the Fill/ Finish Facility

  • Utilize manufacturing process operations and commercial facility experience to participate in cross functional working groups as a user representative to drive the design and implementation of manufacturing related workflows.
  • Participate in Technology Transfer of the Fill & Finish process as a receiving unit.
  • Support and participate in the Commissioning, Qualification and Validation (CQV) of the equipment and facility required for the Fill & Finish Facility.
  • Creation of manufacturing operations related documents which instructs manufacturing workflows and equipment usage with the associated training materials.
  • Subject Matter Expert (SME) for the manufacturing workflows and equipment usage. Able to conduct training and carry out qualification for those topics when required.

Routine Aseptic Fill/ Finish Operations

  • Lead aseptic fill/ finish operations and all the other supporting operations (e.g. visual inspection, cleaning and sterilization of component parts, etc) on the manufacturing floor.
  • Responsible for performing aseptic operations, use of automated filling systems/ equipment, inspection of finished product, labelling and vial reconciliation requirements, changeover procedures for filling line, amongst others.
  • Plan and execute batch production based on production schedule, resource efficiencies and material supplies.
  • Observe strict aseptic and sterile manufacturing practices to ensure compliance to current Good Manufacturing Practice (cGMP).
  • Record manufacturing data and information in a clear, concise, format in accordance to Good Documentation Practice (GDocP) and fundamental data integrity principles.
  • Maintain cleaning and disinfection regimes for the GMP Facility, cleanroom, and associated manufacturing equipment.
  • Coordinate with facilities group for scheduled maintenance on GMP equipment and suite rooms.
  • Technical owner and reviewer of manufacturing documents such as batch manufacturing records, SOPs, forms, and monitoring / log sheets whilst ensuring accuracy and compliance to cGMP and GDocP standards.
  • Responsible for overseeing closure of batch record review and deviation investigation reports to ensure timely batch release of the final product.
  • Participate in cross functional teams to drive non-conformance investigations – root cause analysis, impact assessments and closures. And where applicable, to author and/ or lead investigations, deviations, CAPA and change controls.
  • Proactively identify and resolve technical and operational issues and drive continuous improvement.
  • Develop comprehensive safety risk assessments, promote, and adhere to all environment, health, and safety (EHS) and support EHS initiatives to build a strong safety mindset on the manufacturing floor.

Team Management (Manufacturing Lead)

  • Develop a high performing team in a manufacturing suite against the defined manufacturing KPIs.
  • Chair and participate in the internal manufacturing tier meetings and discussions.
  • Responsible for aspects of daily cleanroom activities from resource planning, suite preparation to batch record sign-off.
  • Champion a strong culture of Right First Time (RFT), low error rate and consistent GMP / cleanroom behaviour.
  • Monitor training and development status and requirements of individual team members.

Requirements

  • Degree in Biotechnology/ Chemical Engineering/ Bioengineering/ Life Sciences or any related field.
  • Minimum of 7 years in a GMP biopharmaceutical manufacturing related role with at least 2 years in a people management role.
  • Proven track record in GMP aseptic fill/ finish or equivalent closed isolator operations for sterile manufacturing operations is mandatory.
  • Applicant must be familiar with a GMP environment, fundamental quality systems (deviation, corrective action preventative action, change control, etc) and regulatory compliance expectations on manufacturing floor.
  • Knowledge of cGMP requirements with an understanding of phase-appropriate clinical and commercial expectations.
  • Familiar with six sigma, lean manufacturing principles and other process improvement tools.
  • Strong technical writing abilities with experience in writing SOPs or any other similar technical documents and with a good working knowledge of GMP.
  • Able to work independently with minimal supervision and direction.
  • Experience in applying various Root Cause Analysis tools and designing effective CAPAs to address the identified Root Causes.
  • Good analytical, planning and coordination skills to work in internal cross functional groups and external cross organizational working groups. Good communication and presentation skills are essential.

Preferred Experience(s)

  • Experience in leading a high performing team as well as being a strong team player with demonstrated ability to build positive relationship with a strong set of interpersonal skills.
  • Experience in major CAPEX project like setting up of a manufacturing facility (either green field or brown field projects) as a user representative.
  • Cross functional experience in a supporting department within the biopharmaceutical manufacturing operations such as Quality Assurance, Quality Control or Supply Chain.
  • User experience with applications such as SAP and Trackwise.
  • Proficient in MS Office Suite (Microsoft Word, Microsoft PowerPoint, Microsoft Excel).
  • Excellent written and verbal communication skills.