Senior Scientist - Cellular Therapies & Logistics Lead

Date: 31 Oct 2024

Site: VCCC (Parkville)

Location:

MELBOURNE, VIC, AU, 3000

Company: Peter MacCallum Cancer Centre

Unit: Cryopreservation

Division: Chief Operating Officer

Department: Haematology Operations

Enterprise Agreement: Medical Scientists, Pharmacists and Psychologists

Cryopreservation

The Peter MacCallum Cancer Centre (Peter Mac) is a Victorian public health service and a world-leading comprehensive cancer centre seeking to excel across all spheres of clinical care, research and education. We have the largest cancer research enterprise in Australia and provide treatment to about 40,000 people with cancer each year. We aim to continuously improve cancer care, research and education across all cancers and for all people affected by cancer: changing lives, breaking new ground. Everything we do is underpinned by our core values, Excellence, Compassion and Innovation. Welcoming people from a wide variety of different backgrounds and experiences is critical to fostering innovation, cultivating compassion, attracting top talent and providing the best possible cancer care for our patients.

YOUR ROLE IN OUR FUTURE

Senior Scientist - Cellular Therapies & Logistics Lead

The Senior Scientist role will provide a high quality, effective and innovative service that meets the requirements of the code of Good Manufacturing Practice for Human Blood and Tissues (cGMP), ISO 15189 (Medical Testing) and the clinical needs of patients within Cryopreservation department. This position is responsible for:

Project Management and Implementation of new Standard of care and clinical trial cellular therapy programs
Coordination and Management of existing cellular therapy programs within Cryopreservation department
Logistics Management
Provide training and assessment for all relevant staff relevant staff for processes within Cryopreservation department
Liaise with internal and external stake holders
Act as Deputy for Cryopreservation Manager and Other Senior Scientist within team
Support and participate in all other streams of work within the department

This position is:

Ongoing, Part-Time 0.8FTE (4-days per week) to Full-Time 1.0FTE
Onsite presence essential at 305 Grattan Street, Melbourne, VIC 3000
Basic Salary Range: $106,688.40 - $121,477.20
Advertising from 31st October 2024 to 29th November 2024

Essential Requirements:

B App Sci (Medical Science) or BSc or equivalent with specific training in Haematology
Specific experience in delivering an ISO 15189 compliant and cGMP compliant Cryopreservation service
Recognised scientific training and competence relevant to the position including knowledge in cell therapy/cryopreservation, analytical methods, and information systems (MS Word, Excel, Outlook, Access, LIMS and Explorer/Netscape).
Appropriate experience and knowledge of haematology.
Demonstrable ability to work and communicate cooperatively in a team including other scientists, senior scientists, pathologists, nursing staff, clinical staff, and researchers.
Actively addresses barriers to change, and works collaboratively with the ACT leads and various clinicians within ACT to improve processes for both staff and patients
Ability to manage, train and assess staff
Responsible attitude and work ethic
Hold relevant scientific registration and demonstrate participation in an appropriate Continuing Professional Development program

Desirable Skills:

Experience in delivering a cGMP, NPAAC or FACT compliant Cryopreservation service
Haematology diagnostic laboratory experience.
Logistics Management
Project Management
Understanding of Medical Microbiology

Applicants to this role should provide a covering letter outlining relative key skills and experience to assist us with our assessment.

For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position summary. Alternatively, please contact us using the information below for a confidential discussion.

Hiring Manager: Janu Davawala

Email: janu.davawala@petermac.org

Contact: Luiza Mints-Kotowska

Email: luiza.mints-kotowska@petermac.org

Applications Close: 11:59PM 29th November 2024
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Position Summary

Provision of a high quality, effective and innovative service that meets the requirements of the code of Good Manufacturing Practice for Human Blood and Tissues (cGMP), ISO 15189 (Medical Testing) and the clinical needs of patients within Cryopreservation department.

Key responsibilities will include:

Project Management and Implementation of new Standard of care and clinical trial cellular therapy programs
Coordination and Management of existing cellular therapy programs within Cryopreservation department
Logistics Management
Provide training and assessment for all relevant staff relevant staff for processes within Cryopreservation department
Liaise with internal and external stake holders
Act as Deputy for Cryopreservation Manager and Other Senior Scientist within team
Support and participate in all other streams of work within the department

Enterprise Agreement

Medical Scientists, Pharmacists, and Psychologists

Classification or Salary Range

Medical Scientist Grade 3: RY9 - RZ3

Immunisation Risk Category

Immunisation Category A

Key Relationships

Internal	All members of ACT Liaise with Pathology department, clinicians, COE and PCCTU teams All other PMCC staff within relevant streams
External	Stakeholders contributing to the Cryopreservation program including Cell Therapies Pty Ltd (CTPL) & ACT Different sponsors and clients for clinical trial programs and standard of care programs Services and Consumables provider companies

Education

Skills

Essential Requirements

B App Sci (Medical Science) or BSc or equivalent with specific training in Haematology
Specific experience in delivering an ISO 15189 compliant and cGMP compliant Cryopreservation service
Recognised scientific training and competence relevant to the position including knowledge in cell therapy/cryopreservation, analytical methods, and information systems (MS Word, Excel, Outlook, Access, LIMS and Explorer/Netscape).
Appropriate experience and knowledge of haematology.
Demonstrable ability to work and communicate cooperatively in a team including other scientists, senior scientists, pathologists, nursing staff, clinical staff, and researchers.
Actively addresses barriers to change, and works collaboratively with the ACT leads and various clinicians within ACT to improve processes for both staff and patients
Ability to manage, train and assess staff
Responsible attitude and work ethic
Hold relevant scientific registration and demonstrate participation in an appropriate Continuing Professional Development program

Desireable Requirements

Experience in delivering a cGMP, NPAAC or FACT compliant Cryopreservation service
Haematology diagnostic laboratory experience.
Logistics Management
Project Management
Understanding of Medical Microbiology

Certifications, Licenses & Registrations

Key Accountabilities

Key Accountabilities	Demonstrated by / Key Performance Indicators
1. Performance of manufacturing, testing and quality activities according to PMCC Cryopreservation procedures	Collaborates with the ACT medical and nursing leads to plan scheduling of services and allocation of resources in a timely and responsive manner. Smooth and efficient operation of daily workflow, including participation in scheduling of product collection, product receipt, tracking, dispatch where appropriate, cell processing, cryopreservation, preparing product for administration and product release, and quality assurance sample collection Generates high quality cell therapy products with acceptable turnaround times in compliance with current standard operating procedures. Assists to co-ordinate workflow in PMCC Cryopreservation laboratory, in conjunction with internal stakeholders including but not limited to ACT/ Clinical Haematology and with external collaborators as required. Ability to generate high quality cell therapy products with acceptable turnaround times Monitors, and adheres to key performance indicators and maintains service effectiveness through accurate measures Organise and provide training and assessment for staff for processes relevant to Cryopreservation department Develops and/or applies new technologies and services relevant to PMCC Cryopreservation department as required Ensures stock compliance within specification is available for all streams Escalates risk to the Cryopreservation Manager, ACT medical lead and Operations Director and implements controls to manage risk Provide effective Scientific Support within Cryopreservation department
2. Cellular Therapy Projects Onboarding, Implementation and ongoing management	Lead the onboarding, implementation and ongoing management of Cellular Therapy Projects Meeting attendance as required including Site Initiation Visits Assess the requirements for implementation of new cellular therapy projects including gap assessment and risk assessment against regulatory standards. Liaise and coordinate with relevant internal and external stake holders to onboard and implement all project specific tasks including but not limited to leukapheresis, cell processing/cryopreservation, shipment of cryopreserved products for further manufacturing, Receipt of Final manufactured product, storage and Release for infusion for all standard of care and clinical trials Lead Site qualifying audits, site selection visits and regular Audits as per project requirements Review ,create and Manage documents compliant with quality standards for project implementation Project specific training and assessment for all staff Lead and Manage all aspects of implemented projects

Key Accountabilities (Contd..)

3. Equipment is calibrated and maintained according to laboratory policy & procedures	All documentation is completed including procedures, maintenance records and quality assurance procedures according to laboratory, NATA /ISO 15189 and cGMP standards and protocols. Participation in On-Call roster Assist team to ensure Equipment maintenance is completed in a timely manner
4. Quality Assurance and Non-Conformance Reporting	Manufacturing, testing and documentation consistent with PMCC Cryopreservation processes compliant with NATA/ISO 15189 and cGMP standards Participate in internal and external quality assurance programs, audits and non-conformance reporting Ensure continuous improvement of manufacturing practices and collaborate on resolving any non-conformances or processing/material defects in a timely manner Performs and plan validation of equipments and processes within Cryopreservation department Effective communication of issues to internal and external stake holder and escalation to Cryopreservation Manager, ACT Medical lead and Operations Director Generate reports as required and presents data related to Cryopreservation department work to clinical and multidisciplinary meetings as well as the Clinical Haematology Performance Improvement meeting Adheres to quality systems and procedures of the PMCC Cryopreservation
5. Works as part of a team	Consistently models behaviours that contribute to a culture of respect, excellence, compassion and innovation for patients, families, scientists, and multidisciplinary staff. Consistently adheres to standards and policies of the organisation and ensures they are translated into action across the cryopreservation unit Assist in after-hours and over-time requirements including late shifts and on-call requirements to support Day to day Cryopreservation department operations In collaboration with the Cryopreservation Manager and medical lead of ACT contributes to the recruitment and assessment appraising of staff performance including the completion of their annual discussion Actively promotes the work of PMCC through external committee, professional organisation, or academic engagements Act as Deputy for Cryopreservation Manager and Other Senior Scientist within team Support and participate in all other streams of work within the department
6. Follows PMCC Policies and Procedures	Acts in accordance with PMCC Policy including maintaining appropriate patient and client confidentiality Adheres to the maintenance of safe working practices and the provision of a safe working environment (as outlined in the OHS legislative and regulations) Undergoes performance appraisals in accordance with PMCC guidelines
7. Continued Professional Development (CPD)	Participate in educational training courses, clinical and scientific meetings Under the direction of senior staff, participates in laboratory and hospital research where appropriate and applicable Represents Cryopreservation department work in internal and external scientific meetings, seminars and conferences

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For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position profile. Alternatively, please contact us for a confidential discussion.

Peter Mac requires its staff to be fully vaccinated against COVID-19. Please contact us if you would like to discuss this requirement.

WHY WORK FOR PETER MAC

Peter Mac offer a range of benefits which support our people both personally and professionally.
Our staff benefits include award winning facilities, professional development and events, a health and wellbeing program, flexible work practices and policies and financial benefits such as salary packaging.
We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQI community and people with a disability.