Head of Operations, ATMF

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Note: Applications will be accepted until 11:59 PM on the Posting End Date.

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At UBC we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research innovation and learning for all faculty staff and students. Our commitment to employment equity helps achieve inclusion and fairness brings rich diversity to UBC as a workplace and creates the necessary conditions for a rewarding career.

Job Summary
The Advanced Therapeutics Manufacturing Facility (ATMF) is a new CFI-funded project and is a flagship project of Canadas Immuno-Engineering and Biomanufacturing Hub (CIEBH) a UBC-led national research hub. It is also a key deliverable for the BC MS Cell Therapies Translational Research Network with the goal of accelerating novel cell therapies for neurological and autoimmune diseases. This project is a multi-year multi-phase initiative to build the ATMF good-manufacturing-practice (GMP) biomanufacturing core facility for the production of advanced therapeutics that will meet todays health challenges and increase Canadas pandemic preparedness. The ATMF will be a significant resource for researchers to be able to produce advanced therapeutics for early-phase clinical trials making products such as cells mRNA vaccines and ancillary plasmid DNA.

The Head of Operations is responsible for directing the design and execution of the overall project rollout and subsequent facility operational leadership. The facility will support researchers across UBC and Canada to enable the execution of multi-project large scale research initiatives. The Head of Operations will provide expertise and leadership on facility design in order to support large scale research studies including the design execution and reporting of clinical trials. The Head of Operations will assess the feasibility of proposed research projects and lead innovation in process design and technology integration merit and innovation of proposed studies. They will represent the facility nationally and internationally to incorporate scientific advances and contribute to the design and execution of strategic initiatives nationally and internationally.

Organizational Status
The University of British Columbia is a global centre for research and teaching consistently ranked among the top 20 public universities in the world. Since 1915 UBCs entrepreneurial spirit has embraced innovation and challenged the status quo. UBC encourages its students staff and faculty to challenge convention lead discovery and explore new ways of learning. At UBC bold thinking is given a place to develop into ideas that can change the world.

Our Vision: To Transform Health for Everyone

Ranked among the worlds top medical schools with the fifth-largest MD enrollment in North America the UBC Faculty of Medicine is a leader in both the science and the practice of medicine. Across British Columbia more than 12000 faculty and staff are training the next generation of doctors and health care professionals making remarkable discoveries and helping to create the pathways to better health for our communities at home and around the world.

The Facultycomprised of approximately 2200 administrative support technical/research and management and professional staff as well approximately 650 full-time academic and over 10000 clinical faculty membersis composed of 19 academic basic science and/or clinical departments 3 schools and 25 research centres and institutes. Together with its University and Health Authority partners the Faculty delivers innovative programs and conducts research in the areas of health and life sciences. Faculty staff and trainees are located at university campuses clinical academic campuses in hospital settings and other regionally based centres across the province.

The UBC Vancouver Campus is located on the traditional ancestral and unceded territory of the xʷməθkʷəyəm (Musqueam) people. The City of Vancouver is located on Musqueam Squamish and Tsleil-Waututh First Nations territory.


Work Performed
Leadership and oversight

o As part of the ATMF leadership group ensure that ATMFs strategic goals are aligned with its operational capabilities and long-term growth plans

o Lead cross-functional coordination between production quality assurance quality control engineering and supply chain to maintain operational excellence.

o Develop and implement operational policies procedures and metrics to support efficient and compliant execution of ATMFs programs.

o Ensure all manufacturing operations comply with Health Canada FDA EMA and other relevant regulatory and GMP standards

o Direct the operations of GMP manufacturing activities including facility readiness production scheduling technology transfer process development and continuous improvement initiatives

o Monitor work completed by external contractors to ensure that it meets the specified standards requirements and timelines

o Represent ATMF in governance and stakeholder meetings; communicate operational risks resource needs and performance indicators to institutional leadership

o Provide expertise and leadership for operational issues impacting timelines resource allocation and facility performance

o Oversee the development of a business plan that includes a market analysis and operational plan to support ATMF sustainability; ensure the ATMF design supports the business model; define the facilitys long-term financial and operational model

Finance and HR

o Manage capital and operating budgets provide financial oversight for all operational activities and contribute to long-term financial planning for the facility

o Supervise a team of up to 20 staff

o Liaise with other academic GMP facilities across Canada to share knowledge and coordinate complementarity

o Work with future facility users consultants and vendors to plan equipment purchases including negotiating with vendors to optimize warranties/service contracts and installation/operational qualification and maximize consumable discounts

o Oversee financial activity and operational budget assist in the development of financial models and management of available resources

o Liaise with the UBC Faculty of Medicine and Institutional Programs Office Finance staff to prepare budgets track expenses and report

o Direct resource planning and staffing in collaboration with HR and senior management ensuring the facility is adequately supported for current and future workload.

o Provide expertise and leadership on ATMF human resources services training and qualification of personnel staff development employee relations equity and terms of employment

Administrative

o Liaise with internal and external units and organizations on behalf of the ATMF; participate in various committees and working groups contributing towards goals and objectives

o Lead the organization of regular meetings with project stakeholders (e.g. leadership users consultants vendors) disseminate resulting information as appropriate

o Foster a culture of accountability safety innovation and compliance throughout all areas of ATMF operations

o Develop tracking systems for facility inventory and maintenance including equipment purchased used and location equipment maintenance and calibration

o Lead the design implementation and review of the quality management system the document management system quality risk management and knowledge management programs and systems

o Design and implement quality governance quality escalation and quality management review processes

o Develop and manage comprehensive standard operating procedures for operations in collaboration with quality assurance quality control and process development teams

o Act on behalf of ATMF as delegated/requested by the project lead

o Provide general day-to-day support as required to the project lead

Consequence of Error/Judgement
Error in the operation of the ATMF would negatively impact users and could incur significant cost and research delays. Failure to maintain compliance with federal regulations and standards would jeopardize facility operation and potentially endanger the reputation of the facility. Poor attention to detail and erroneous data will negatively impact on the progress and direction of research projects.

Decisions made have a wide impact in the communications and operations of the affected projects researchers and collaborators. Errors may affect all users by stopping or impairing projects. Major errors may cause failure to meet funding-related deadlines and research milestones compromising current and future funding. Valuable reagents research time and money would be lost. ATMF operation hazards require proper adherence to safe work practices to avoid risking an accident.

The work performed evolves continuously to match rapidly changing circumstances and demands of the user community. Staying up to date with the latest technology developments and best practices and making appropriate team decisions are essential. Failure to do so would impact the ATMFs ability to support leading edge research at the global level.

Supervision Received
The Head of Operations works independently and reports to the ATMF Project Lead. They exercise considerable independent judgement and initiative in the planning of ATMF implementation of projects operations resource allocation and human resource management. Work is reviewed in terms of achievement of defined short and long-term goals.

Supervision Given
Provides guidance support and content advice/expertise to all faculty trainees and staff working with the facility. Provides direct supervision to relevant ATMF staff including project managers and other senior personnel.

Ensures users (faculty research staff students and external users) have appropriate training and oversees activities of contract workers and service people in ATMF.

Ensures safety policies are followed by all users by observation of work practices in the facility.

Minimum Qualifications
For research project leadership a post-graduate degree or an equivalent professional designation is required with a minimum of five years of related experience including experience in a field of specialization or an equivalent combination of education and experience. Otherwise an undergraduate degree in a relevant discipline is required with a minimum of seven years of related experience or an equivalent combination of education and experience.

- Willingness to respect diverse perspectives including perspectives in conflict with ones own

- Demonstrates a commitment to enhancing ones own awareness knowledge and skills related to equity diversity and inclusion

Preferred Qualifications

Demonstrated excellent managerial skills and experience in supervising personnel. Four years or equivalent combination of education and experience in quality control and quality assurance of GMP facilities. At least three years of experience working with clean laboratories. Demonstrated prudent judgement under pressure and in situations of risk. Demonstrated experience in clean laboratory and quality management systems. Knowledge and experience with complex scientific analytical instrumentation is preferred. Evidence of excellent quality management system training and conscientious attention to detail and task completion. Proven ability to learn new techniques ability to support troubleshooting. Computer experience required including facility with Microsoft Office and inventory software.

Superior writing and effective translation of complex information into clear and succinct language for a broader audience is essential. Creative problem solving and decision-making; mentorship abilities. Computer competency with knowledge of spreadsheet database and word processing applications. Ability to work at the highest strategic levels to gain and maintain the respect of senior administration and also to take strategy and move it through to tactics and action. Ability to deal with senior University Officers and external stakeholders in a manner which facilitates cooperation and consensus building. Demonstrated ability to work collaboratively and interact with empathy understanding and humility with people from diverse backgrounds and with diverse identities perspectives and behaviors. Excellent political acuity tact judgment and discretion. Ability to interpret and evaluate policy and procedural requirements. Must be highly self-motivated and sustain a high degree of initiative. Proven ability to analyze prioritize and work effectively under pressure to meet deadlines. Proven judgment and decision-making skills particularly in areas where there are no established policies or guidelines. Ability to take initiative manage effectively and meet goals in a complex environment. Ability to foresee prevent and resolve conflicts and other problems.