Job Position
Intern, Manufcaturing

Reports To

Senior Manager / Manager, Manufacturing

Responsibilities

• Develop and maintain Job aids, Training materials and curricula related to process operations, and process theories with the support of Manufacturing Managers and MFG Specialist / Biotechnologists.
• Create Safety Risk Assessment (using tools such as pFMEA, HAZID, HAZOP) related to usage of process equipment and process operations.
• Support and perform cell manufacturing related activities according to written Batch Manufacturing Records (BMRs) and associated Standard Operating Procedures (SOPs).
• Adhere to strict aseptic techniques and sterile manufacturing guidelines when performing cell therapy production in the Training Lab or Good Manufacturing Practice (GMP) cleanroom facility.
• Document production activities and outcomes using Good Documentation Practices (GDP) in the corresponding batch records and log sheets
• Clean and perform basic maintenance of process equipment and cleanroom according to SOPs
• Assist and perform inventory planning and control in the cleanroom through Kanban and 5S workflows.
• Assist in Quality Management System aspects of cleanroom management including deviation investigations, CAPA implementation and change control assessments.

Requirements

• Degree in Pharmaceutical Engineering/Biotechnology/Chemical Engineering/Bioengineering/Life Sciences or any related field.
• Previous experience in the biopharmaceutical or related environment is a plus. Applicant must be familiar with a GMP environment and compliance expectations in a cleanroom manufacturing area.
• Competent in MS Excel (able to use Pivot Tables, Condition Formatting and other basic formulas), MS Word (familiar with the use of Styles, and other basic formatting tools) and MS PowerPoint.
• Good communication skills and able to be a team player.
• Passionate, self-motivated and willingness to learn.
• Ability to work long hours occasionally when required.
• Strong technical writing abilities.
• Good analytical, planning and coordination skills.

Job Position
Senior Manager / Manager, Clinical Project

Reports To

Associate Director, Clinical Operations

Position Summary

This individual will be responsible for the planning and executing of trials for the Clinical Operations function. He/she will work closely with multi-disciplinary departments and will require a solid understanding of the clinical trial lifecycle management such as study startup, feasibility, site selection, patient recruitment, project management, site management and site quality oversight. He/she will also be overseeing CROs and other related third-party vendors which are delegated to execute studies on Tessa’s behalf.

Job Descriptions:

• Ensure that global clinical strategies are translated to study specific strategies.
• Ensure that the trials are run in adherence to all relevant regulations including GCP, ICH, local regulatory requirements, as well as SOPs and policies.
• Provide operational input into study designs, protocols and study plans to ensure that they are operationally feasible at the country, site, and patient levels
• Oversees the execution and adherence to all integrated study operation plans, with inputs from key stakeholders.
• Oversee the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with CRO Management and key stake holders
• Set Key Performance Indicators (KPIs) and roll out metrics to track the quality and performance of the studies.
• Monitor study progress, study budget, study timeline
• Identify quality and deliverable risks, roll mitigation plans together with the relevant stakeholders, to ensure risks are minimized.
• Establish good working relationships with the participating sites and be the point of sponsor contact escalated site issues.
• Conduct regular onsite monitor assessment visits.
• Provide inputs into responses for site audit report and Inspection report as well as be responsible for oversight of associated plans

Requirements

• Bachelor Degree in a field of Biomedical science, pharmacy, nursing, or medical related courses.
• At least 10 years’ experience working in clinical research and at least 4 years of clinical project management experience in oncology studies.
• In depth knowledge of oncology trials requirements, clinical research principles such as ICH GCP as well as regulatory requirements.
• Strong communication and influencing skills
• Strong organizational and problem-solving skills
• Strong supervision and oversight skills
• Effective presentation skills
• Strong ability to deliver results to the appropriate quality and timeline metrics
• Good judgment
• Ability to manage competing priorities
• Experiences in immuno-oncology and/or gene and cell therapy studies are advantages.
• Proficiency in MS Excel required, programming knowledge an advantage

Job Position
Intern, Process Sciences and Technology

Reports To

Senior Manager, MSAT Process

Responsibilities

• Support PSAT in characterization of process parameters to support the BLA submission data package.
• Support in the development of process troubleshooting and process monitoring trending systems and tools
• Support PSAT in Tech transfer for new process / product / facility
• Maintain strong working relationships with inter-department stakeholders as well as external contractors
• Communicate effectively across functions. Align goals and priorities for the timely execution of activities. Engage in both technical and tactical discussions to ensure stakeholder alignment.
• Excellent team player with willingness to learn, share and find solutions together with the team.

Requirements

• Diploma/Degree in Engineering or Biotechnology or any related field
• Knowledge with cell therapies/immunology is preferred. Alternatively, strong ability to learn.
• Able to communicate with impact, ensuring alignment and negotiating positive outcomes in his/her area of work.
• Good time management
• An excellent team player with willingness to learn, share and find solutions together with the team.

Job Position
Intern, Process Sciences and Technology

Reports To
Expert, MSAT Validation

Responsibilities

• Responsible for creation of testing instruments SOPs used in validation. Execution of temperature mapping studies. Compilation and presentation of validation data.
• Support the creation of validation/study protocols. Support the creation of EHS risk assessment related to validation activities.
• Maintain the validation project deliverables and validation inventory.
• Establish Visual board to facilitate validation operations / projects
• Communicate regular progress reports of assignments

Requirements

• Proficient in Microsoft words, excel and powerpoint

Job Position
Laboratory Specialist (1 Year Contract)

Reports To
Director, Product Development

Summary

The position reports to the Director of Product Development and is based in Tessa’s Singapore Tech Ops Office. The candidate will be responsible for daily scientific operations, laboratory housekeeping and equipment maintenance. He/She will support tasks specific for various projects within Product Development.

Responsibilities

• Maintains laboratory inventory, responsible for ordering reagents and consumables.
• Maintenance of equipment, performs preventive maintenance and responsible for handling equipment repair via external vendors
• Responsible for equipment maintenance and reagent information on file.
• Assists and troubleshoots qPCR, flow and ELISA based assays
• Assists on various assays critical for defined projects. Participates in group and project meetings.
• Supports management of CMOs for the Product Development team and relevant stakeholders
• Assist in project management and logistic support for scientific and technical aspects of CMOs, Satellite laboratories from planning, budget, following up contracts, tracking progress, and timeline.
• Supports other product development projects (e.g., contract research organizations, contract manufacturers, service/supply vendors).
• Develop and maintain positive relationships with collaborative partners ensuring team environment and alignment with Tessa strategic goals
• Updates work knowledge by participating in educational opportunities; reading technical publications etc.

Requirements

• Bachelors’ degree in life science with at at least 2 years’ experience in life science industry or GMP/GLP regulated laboratories with basic knowledge of GMP, GCP, and CMC & QA guidelines. Fresh graduates are welcome to apply.
• Basic knowledge of cell culture, ELISA, qPCR, FACS techniques.
• Strong inter-personal skills and verbal/written communication
• Strong problem solving and critical thinking skills, and the ability to multitask.

Job Position
Director, Business Development

Reports To
Chief Financial Officer

Responsibilities

• Work closely with senior management to propose business development strategies and functional plans for the Company in the US and EU to ensure business development frameworks incorporate the broader strategic considerations
• Drive building relationships with external parties to increase awareness of business development opportunities, including ensuring a presence at all major partnering and scientific meetings in US and EU
• Facilitate timely and fact-based decision making to ensure that market opportunities are realized
• Provide input and expertise on all business development activities, including significant commercial transactional matters, such as mergers & acquisitions, joint ventures, and strategic alliances
• Liaise with teams of internal and external experts to evaluate product opportunities, including in-house and external scientific, clinical, manufacturing, regulatory, marketing, financial, legal, IP experts

 Work closely with the Corporate Development team to:

• Identify and evaluate potential in and out licensing opportunities, product acquisitions, alliances, and commercial constructs which will complement Tessa’s long-term strategy
• Develop proposals for structuring and negotiating deals in consultation with senior management team
• Organize full due diligence, including commercial, R&D, and input from non-R&D functions, if required, e.g. IP, Legal
• Prepare due diligence reports and risk/opportunity assessment

Requirements

• Science or Business Degree; MBA and/or PhD preferred
• Strong scientific background and experience working in a research/scientific environment
• Strong and established network in the US Oncology Business Development community, including pharmaceutical companies, biotech, research institutions and venture capital
• 10+ years of work experience in pharmaceutical and biotech companies with a minimum 5+ years in a Business Development role
• Experience in leading and collaboration with global cross-functional teams with strong interpersonal skills and ability to multi-task
• Proven deal sheet
• Strong commercial skills with a strong understanding of the US and EU market
• Strong knowledge in the areas of oncology, novel cell therapies and immunotherapy products
• Strategy Development – Proficient in developing business strategies and communicating and ensuring its implementation
• Understanding and commitment to teamwork
• Strong negotiation skills; ability to persuade/influence and effectively gain agreement; resourceful and creative problem-solving skills
• Networking and persuasion skills to build and maintain relationships – both internal and external
• Communication – use communication techniques (oral or written) at a high level, in a broad range of non-routine situations and to a variety of audiences, taking into consideration their motivation, needs and behaviours
• Ability to operate at global working hours, communicating with counterparts across different time zones
• Willingness to travel in US and EU (up to 50% time), occasional travel to Asia/Singapore

Job Position
Senior Executive, Human Resources

Reports To
Vice President, Human Resources

Responsibilities

Talent Acquisition

• Implement a comprehensive recruitment plan consistent with the strategic vision of Tessa
• Business partner with hiring manager and business departments to develop a strategic sourcing strategy
• Utilise creative and non-traditional recruitment strategies to help build an experienced, skilled, and diverse talent pool
• Source resumes through various forms of media including online databases and networking with numerous organisations locally and internationally.
• Establish and maintain successful relationships with educational institutions, search firms, professional associations and other organisations that provide recruitment value.
• Manage recruitment projects and initiatives.
• Assist hiring managers with status updates, applicant repositioning and other common requests.
• Professionally represent Tessa at local and international job fairs, conventions and conferences and maintain positive relationships with internal and external contacts
• Maintain a solid understanding/knowledge of the Tessa Culture. Be a brand ambassador and communicate the company philosophy of development and growth to potential candidates
• Implement online and offline employer branding activities
• Prepare and review annual recruitment budget

Business Partner

• Responsible for aligning business objectives with employees and management in designated business unit.
• Formulates partnerships across the HR function to deliver value-added service to management and employees that reflects the business objectives of the organization.
• Consults with line management, providing HR guidance when appropriate.
• Analyses trends and metrics in partnership with the HR group to develop solutions, programs and policies.
• Manages and resolves complex employee relations issues. Conducts effective, thorough and objective investigations.
• Provides day-to-day performance management guidance to line management (e.g., coaching, counselling, career development, disciplinary actions).
• Works closely with management and employees to improve work relationships, build morale, and increase productivity and retention.
• Provides HR policy guidance and interpretation.
• Provides guidance and input on business unit restructures, workforce planning and succession planning.
• Identifies training needs for business units and individual executive coaching needs.
• Participates in evaluation and monitoring of training programs to ensure success. Follows up to ensure training objectives are met.

Requirements

• Degree in Human Resources Management or relevant field or proven work experience in Talent Acquisition or similar role
• 5 years’ experience in Talent Acquisition and Business Partnering.
• Demonstrable experience managing full-cycle recruiting and employer branding initiatives
• Solid understanding of sourcing techniques and tools
• Good team-management abilities
• Excellent communication skills with the ability to foster long-term relationships (with internal teams, external partners and candidates)
• Self-starter; ability to work in a fast-paced and dynamic environment
• Proficient in the use of job boards and various forms of media for recruiting/ branding purposes
• Excellent communication skills, both written and verbal

Job Position

Senior Manager/Manager, Manufacturing

Reports To
Head of Manufacturing

As a Manufacturing Manager in a growing and dynamic team, you will use your passion, creativity and diverse industry experience to streamline and develop innovative manufacturing processes to cater for the needs of autologous therapies while being compliant to cGMP requirements. You will lead and guide the team to ensure excellent standards of manufacturability, cleanroom operational efficiency, yield improvement, failure analysis, while identifying opportunities for advanced process controls, cost reduction, and automation of unit operations together with the Process Development team. You will also collaborate with other multi-disciplinary teams to maintain strong functional relationship to co-develop and structure future requirements for product commercialisation.

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.

Responsibilities

Manufacturing Operations

• Lead and manage activities on the manufacturing floor;
• Accountable for day-to-day Manufacturing activities while complying to Quality, cGMP and EHS requirements;
• Management and planning of manufacturing activities, namely – (1) schedule and capacity planning, (2) patient sample production status, (3) oversee and review batch records and (4) efficient allocation of manpower and resources;
• Effective Change Control and Project Management – (1) initiate, design and oversee the smooth implementation of manufacturing change controls, (2) manage and review interdepartmental change controls;
• Effective management of deviation reporting, guide and lead team to – (1) appropriately raised deviations when required, (2) conduct thoughtful and meaningful RCA and CAPA relating to deviation;
• Technical writing of SOPs, Batch Record, Investigation Reports, amongst others (when required; example for new pipeline product launch, etc);
• 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 with other departments to achieve the overall goals for operations;

Strategy, Planning and Business Development

• Jointly develop and execute manufacturing strategies for new cell therapy products tech transfer programs, GMP manufacturing processes, automation initiatives, amongst others;
• Develop, plan and implement manufacturing operations and business processes for new facility start-up. SOPs, workflow and processes will be critically thought out to cater for cell therapy products and appropriate for clinical and commercial manufacturing;
• Jointly lead and drive commissioning, qualification and validation activities for new sites;

Management and People Development

• Actively and jointly participate in the preparation and management of department’s goals, project, budget and others;
• Providing clear, organised and meaningful updates and analysis on manufacturing-related operations and projects to facilitate decision-making at the Technical Operations or Program level;
• 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 backup.

Requirements

• Bachelors, Masters, or PhD in Life Science / Biomedical Sciences / Chemical Engineering / Bioengineering / Bio-processing and other relevant scientific or engineering disciplines;
• 7–10 years of relevant cell and gene therapy (or biologics) clinical / commercial manufacturing experience;
• At least 4 years of leadership experience with track record of building and leading exceptional teams;
• Extensive experience in GMP cleanroom operations and aseptic processing;
• Strong knowledge and experience in cell therapy manufacturing (or upstream cell culture processes) and cryopreservation;
• Strong working knowledge of cGMP guidelines and relevant regulatory knowledge (FDA, EMA, PICS);
• Highly skilled in applying Root Cause Analysis tools and in designing meaningful CAPAs;
• Technical writing skills for the authorship of internal/external documents and approve technical documents;
• Knowledge of T cell biology and immunology will be advantageous;
• Highly proficient with Microsoft Office Suite and able to efficiently utilise MS Excel, MS Word, or MS PowerPoint for presentation and management reporting.
• 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 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;
• 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

Job Position
Analyst, Corporate Strategy & Development

Reports To
Senior Director, Corporate Strategy & Development

Position Summary

The Analyst, Corporate Strategy is an integral part of the Tessa Corporate Development Office and is responsible for supporting Tessa’s strategy, business development, and corporate finance activities in support of our key priorities. The position enables interaction with all levels of management within the organization as well as external parties, including potential partners, financial advisors, and consultants. Work output will be featured at the highest levels of the company, with real opportunity to influence business direction. Ideally suited for high-performing young professionals early in their career, the corporate strategy team enables direct exposure to the executive management team, working alongside talented, committed, and supportive teammates. Due to Tessa’s entrepreneurial culture, members of the team are encouraged to explore learn across functions and explore their interests. The skill set and knowledge gained can be applied within the biopharma or medical industry or can be easily transferred across industries and roles.

Responsibilities

• This role will provide direct support to the CEO’s Office for all corporate strategy-related and business development activities, with responsibility for aiding the development and implementation of strategies to set the direction and accelerate growth of the business. Members of the team will contribute to a range of initiatives:
  • Working closely with company leadership across various functions to develop long-range corporate and scientific strategic plans, to craft company positioning, and to create key metrics.
  • Collaborating with functional teams and acting as the internal cross-functional liaison in organizing scientific, clinical, and operational resources for high-priority initiatives, such as clinical trials.
  • Spearheading reports and analyses on emerging trends, competitive dynamics, and collaboration opportunities to inform strategic priorities and plans.
  • Supporting in the development of board and management updates and presentations as well as contributing to investor-related communications (e.g. corporate presentation, press releases, etc.).
  • Building and maintaining the Tessa electronic data room for out-bound due diligence and working with external partners to manage diligence questions and process.
  • Managing workstreams for the CEO and within the team, including tracking action items, organizing meetings, preparing meeting agendas, recording meeting minutes, and coordinating global and sub-team meetings and activities.

Requirements

• Bachelor’s degree in Science, Engineering, or Business
• High motivation, strong work ethic, maturity, and personal initiative
• Effective oral and written communication skills
• Empathy, adaptability, and emotional intelligence
• Strong attention to detail, with a quality-focused mindset
• High level of intellectual curiosity and creativity
• Self-discipline for planning and organizing tasks
• Aptitude for, and enjoyment of, working in teams
• Strong interpersonal skills and the ability to interact professionally representing Tessa Therapeutics