Project Portfolio Manager Melbourne, Australia Full Time

Transcription

1 Project Portfolio Manager Melbourne, Australia Full Time Exciting opportunity in emerging field of cell based therapies. High growth company with deep experience, international reputation. Executing growth plan built around growing pipeline of projects in the hottest part of the field. Pivotal growth role ensuring scalability of our proven competence. ell Therapies Pty Ltd (TPL) ( is leading the provision of cgmp manufacturing and distribution infrastructure for cell based therapies in the Asia Pacific region. TPL provides contract translation and clinical trial manufacturing services to product development companies, and then supports commercialisation in the region via in-licensing and marketing or further contract manufacturing and distribution. Our expertise, developed since 2001, is "needle-to-needle" ensuring complete product security and control and includes collection management (especially apheresis), cryopreservation, cell processing, distribution and marketing. TPL operates cell processing facilities at our home base at The Peter Macallum ancer entre (Peter Mac - our parent) in Melbourne and the R for ell Therapy Manufacturing in Adelaide, with additional facilities planned to expand our capacity at least four-fold in the near future in both Australia and South East Asia. TPL holds numerous cgmp manufacturing licenses with Australia's Therapeutic Goods Administration and is proud to be working with some of the world's leading stem cell companies. Our product and project pipeline includes regenerative medicine (musculo-skeletal repair), immunotherapy (including T-cells and antigen presenting cell therapies for cancer and infectious diseases) and gene therapies. Growth of our business and expansion of our project pipeline has created an opportunity for an experienced program manager excited by the potential to bring breakthrough therapies to market and grow a substantial enterprise. The Project Portfolio Manager reports to the EO and SO, will be a member of the ell Therapies Leadership team, and will be responsible for the quality of all aspects of project delivery at TPL. This pivotal role at the centre of product delivery for our clients, licensors and patients includes but is not limited to: Establishing and continuously improving business wide project management tools, processes and project leaders ensuring an already effective project delivery model can grow and scale as our opportunities do Scoping and pricing/costing potential new projects (in collaboration with business development, finance, and relevant technical experts) Establishing and tracking projects; troubleshooting where required

2 Managing the agenda of the Project Portfolio Steering ommittee, the key project governance forum for ell Therapies The Project Portfolio Manager will oversee all projects across the business except business development and the project leaders accountable for the delivery of each project. Projects range from process development and technology transfer of novel human cell-based therapies to facility expansions, strategic alliance management and major change programs. Project teams range from individual technical experts or ell Therapy Specialists to large cross-functional teams spanning the entire organisation and external clients, clinicians, RO s, etc. All operations are conducted under cgmp conditions. Preferred candidates will be experienced project managers or change leaders with extensive healthcare product manufacturing or development experience, potentially as part of program or project management offices. You will be able to demonstrate results and impact in the following areas: Managing portfolios of complex multi-functional pharmaceutical, biological, medical device or cellular therapy process development and/or manufacturing projects in a GMP environment Working with, developing and managing scientific and technical staff in a matrix environment Formal training or qualifications in one or more of project management, change management or risk management Extensive commercial project and/or alliance management experience with large & small companies ustomer relationship management and pricing, business development or contracting for MO or licensing agreements Demonstrated skills and experience in specialized biologicals (peptides, proteins, viruses, cells or tissues) for human therapy are highly desirable Salary will be commensurate with experience, track record and fit with selection criteria. Outstanding candidates may also be eligible to participate in TPL's equity based long term incentive plan. International applicants with cellular therapy production experience are encouraged and relocation support will be available, subject to meeting the requirements for appropriate residency and work permits for Australia. Offers of employment will be subject to candidates providing a satisfactory National Police ertificate (police check) or equivalent and satisfactory health and vaccination assessments. Applications, including a covering letter addressing the selection criteria, key requirements of the role and a current V should be submitted to: Anne Downing, ell Therapies, Ground Floor, 10 St Andrews Place, East Melbourne, VI 3002 or ed to: employment@celltherapies.com.au by Friday 6 February 2015.

3 Position Description Job Title Locations Reporting To Main Purpose of Position Project Portfolio Manager Primary location: Melbourne with facilities at: Peter Macallum ancer entre, East Melbourne until 2016 Peter Macallum ancer entre at V, Parkville, Melbourne, after 2016 UNISA, Mawson Lakes, Adelaide Other manufacturing sites in ASEAN Direct: EO Indirect: SO The Project Portfolio Manager will be responsible for the quality of all aspects of project delivery at ell Therapies. This includes but is not limited to: Establishment of business wide project management tools and processes; Scoping and pricing/costing potential new projects (in collaboration with business development, finance, and relevant technical experts) Developing project leaders/managers Establishing and tracking projects Managing the agenda of the Project Portfolio Steering ommittee, the key project governance forum for ell Therapies Troubleshooting for critical projects that encounter difficulties The Project Portfolio Manager will lead a team of project managers or leaders from across the business each of whom will be accountable for the delivery of individual projects. Projects range from process development and technology transfer of novel human cell-based therapies to facility expansions, strategic alliance management and major change programs. Project teams will range from individual technical experts or ell Therapy Specialists to large cross-functional teams spanning the entire organisation and external providers including clients, clinicians, RO s, etc. lients may require consulting services or contract manufacturing for clinical trials through to commercial manufacturing and distribution under license of cellular and tissue therapy products. All operations are conducted under cgmp conditions. Key Effectiveness Areas 1. Establishment of business wide project management tools and processes a. Implementation and continuous improvement of stage-gated product and project development processes b. Establishment of simple, pragmatic but effective project management, tracking and reporting tools c. Works with ell Therapy (and Peter Mac) leadership to contribute to the rapid expansion of project activities prior to the relocation to the Victorian omprehensive ancer entre. 2. Scoping and pricing/costing potential new projects (in collaboration with business development, finance, and relevant technical experts) a. Efficiently managing the development of project plans and budgets at a level of detail commensurate with project size, scope and risk and stage of business development b. ollaborate effectively with business development, finance and subject matter experts to ensure appropriate ownership of proposal inputs at time projects receive Leadership Team approval 3. Developing project leaders/managers a. Identifying skills required for each project and matching these with available talent b. Recommending project leaders for each project (may come from across the organization) to the Project Portfolio Steering ommittee c. oaching and developing the project management skills of chosen project managers d. Identifying skill and competency gaps and raising with Leadership Team e. Supports new workforce models that improve efficiency and encourage role and job enlargement 4. Establishing and tracking projects

4 Decision Making Authority Key Relationships Experience/Qualifications a. Facilitating, with project leaders and ell Therapy Specialists, project kick-offs/launches b. Ensuring appropriate charters, staffing, linkages to client organisation, confidential information management plans, etc are in place c. Negotiates trade-offs with functional leaders for scarce/constrained resources in line with enterprise priorities d. Agreeing key milestones with project team and ensuring progress reporting against those e. Periodic traffic light reporting of project portfolio progress f. Financial oversight of project related expenditure within relevant cost centres g. Identification of red flags h. Appropriate participation in individual project meetings 5. Managing the agenda of the Project Portfolio Steering ommittee, the key project governance forum for ell Therapies a. Establishing a standing agenda b. Ensuring appropriate attendees c. Scheduling project deep dive reviews at a frequency appropriate to the importance and complexity of each project d. Ensuring red flags are identified early and appropriately addressed e. Managing the business of the ommittee in line with enterprise priorities 6. Troubleshooting for critical projects that encounter difficulties a. Establishing a risk management plan for each project b. Working with ell Therapy Specialists and project leaders to address risks and critical path timeline or budget misses c. Ensuring access to appropriate resources (from with ell Therapies, Peter Mac, clients or elsewhere) are available for project delivery d. Works with local staff to support development projects at new remote facilities in Adelaide and ASEAN Project specific expenditure consistent with project budgets and ell Therapies and Peter Mac delegations of authority ell therapy project team resource management, in accordance with professional & regulatory standards and organizational policies. Internal: Project managers (who report primarily to relevant functional leaders across the business and indirectly to the ell Therapy Program Manager for project management purposes) Business Development Facilities/production Development scientists/subject matter experts QA and RA teams External: Peter Macallum ancer entre and entre for Blood ell Therapies stakeholders and sponsors ell Therapies Pty Ltd contracted lients and sponsors ommercial facilities providers at V. Nextell Pty Ltd & R for ell Therapy Manufacturing researchers ASEAN partners and facilities Expected 1. Demonstrated skills in managing portfolios of complex multi-functional pharmaceutical, biological, medical device or cellular therapy process development and/or manufacturing projects in a GMP environment. 2. Skills and experience in working with, developing and managing scientific and technical staff in a matrix environment, with demonstrable communication skills, time management skills and timely delivery of required deliverables. 3. Formal training or qualifications in one or more of project management, change management or risk management 4. Extensive commercial project and/or alliance management experience with large & small companies

5 5. Effective and professional communication. 6. ustomer relationship management and pricing, business development or contracting for MO or licensing agreements Highly Desirable 7. Demonstrated skills and experience in specialized biologicals (peptides, proteins, viruses, cells or tissues) for human therapy 8. Masters or equivalent post graduate qualifications in pharmaceutical or biological sciences, business administration or project and change management 9. Demonstrable experience and prior knowledge of Good Manufacturing Practice (GMP) for Human Blood & Tissues or Biologics as well as relevant clinical trial frameworks in one or more of ANZ, US or EU 10. Knowledge and experience of PI/S annexes 1, 2 and Regulatory or quality management experience including preparation of regulatory dossiers Performance Objectives Establishment of business wide project management tools and processes Scoping and pricing/costing potential new projects Key Performance Indicators Documentation of stage gated project governance process Simplicity and effectiveness of project reporting tools Implementation of tools and process across all projects Effectiveness of integration with Business Development process Standardisation of pricing/costing process and format Turn-around time of quotations Accuracy of quotations Quality of cross-functional input Developing project managers/leaders Establishing and tracking projects Managing the agenda of the Project Portfolio Steering ommittee Troubleshooting for critical projects that encounter difficulties Provides safe working environment ontinuing education Documented contribution to performance reviews of project leaders Effectiveness of individual coaching Facilitation of lessons learned seminars after and at appropriate times during projects Structured kick-off process for all projects Availability of regular project status reports Delivery against major project milestones (time and budget) ompliance with key policies and standards, particularly related to GMP, privacy and confidential information Alignment of agenda with current business priorities Effectiveness of ommittee decision-making Quality of information provided to ommittee to facilitate decisionmaking Existence of risk assessment and risk management plan for each project Effectiveness of project specific remediation interventions Minimizes OHS risks to staff and visitors. Participates in educational activities including attendance at internal and external training courses, clinical and scientific meetings. Develops, supports and manages links with relevant agencies, societies, companies & universities, with leadership roles in relevant committees and societies. Develops, extends and maintains expertise in project management, decision-making effectiveness, regulatory and quality affairs. Actively shares new learnings from projects with ell Therapy Specialist team (within the limits of client confidentiality).

6 OH&S, Infection ontrol, biological safety Privacy omplies with infection control and IB policies and procedures 100% of the time ompletes incident reports 100% of the time and responds appropriately to OH&S incidents Attends Health and Safety training on emergency procedures annually and is capable of identifying emergency equipment in place. Direct care staff will attend the yearly update on theory of fire, code red and orange responses and use of extinguishers. Follows established procedures. Adheres to the ell Therapies commercial conflicts and privacy policies Performance Objectives Human Resource Management & Performance Development and Review: Recruitment and Selection: Performance Management Proficiency Level required to be indicated against each value. Key Performance Indicators omplies with institutional Policies to maintain a safe work place Participates and/or conducts annual performance development and review on 100% of staff Follows established procedures and guidelines. Takes all reasonable steps to prevent bullying and discrimination and harassment in the work place. Adheres to ell Therapies Policy Adheres to ell Therapies Policy A= Proficient B= Advanced = Expert Values Key Behaviours: Proficiency Level Integrity Safety Excellence reativity Transparency EO Signature We do the right things and we do things right, even when that comes at a cost. We make decisions based on evidence and in compliance with legal and moral obligations (including but not limited to those relating to confidential information and intellectual property). Patient safety always comes first. The practice of medicine carries inherent risks and we will work with our partners to exercise professional judgment, skill and care to ensure that we do not knowingly put patient safety at unnecessary risk and that we are transparent about risks We will invest time and resources to lead our field. We aim to exceed minimum performance standards and regulations. We proactively disseminate new knowledge, skills and techniques with each other. We find ways to bring novel therapies to patients quickly and cost effectively, but consistently with our values. We believe that effective teams, both internally and with partners, are a key contributor to our creativity. We are open and honest in our dealings with our clients, suppliers, and each other. We do not offer or accept personal inducements for any act in connection with our business and proactively disclose and manage potential conflicts of interest. Staff member Privacy Statement: Information may be collected and stored for the purpose of recruitment and selection. The information will only be used and disclosed for the primary purpose of its collection. Some exceptions exist. These may be obtained from the Privacy Officer.