Manager, Process Development, Nucleic Acid Therapies, ATMF

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Job Summary
The Advanced Therapeutics Manufacturing Facility (ATMF) is a new CFI-funded project and a flagship project of Canadas Immuno-Engineering and Biomanufacturing Hub (CIEBH) a UBC-led national research hub that aims to align the critical mass of immune-engineering expertise with biomanufacturing and public health strengths concentrated in BC. 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 multi-year multi-phase project aims to build a Good Manufacturing Practice (GMP) biomanufacturing core facility to produce advanced therapeutics - such as cells mRNA vaccines and ancillary plasmid DNA - essential for early-phase clinical trials addressing current health challenges and strengthening Canadas pandemic preparedness

The Manager Process Development Nucleic Acids provides senior-level technical leadership and professional autonomy for the design validation and governance of a variety of process development activities conducted in the Process Development lab at the ATMF. Specifically the Manager Process Development Nucleic Acids will be responsible for determining and executing the technical pathways required to translate internal and external laboratory-scale research into robust scalable and GMP-compliant products related to advance biomanufacturing technologies and various nucleic acid therapeutic products including but not limited to plasmids mRNA/LNP formulations and viral vectors.

This role exercises independent judgement in the design implementation and optimization of upstream and downstream processes data interpretation manufacturing protocol development and technology transfer to GMP production environments. The Manager Process Development Nucleic Acids acts as a technical authority in collaboration with ATMF leadership senior university administration and internal and external research partners. The role will lead and supervise researchers and technical staff involved in process development research.

The position is based in the ATMF Process Development lab at the UBC Vancouver Campus. Travel will be required between multiple laboratory sites including BCCHR and BC Cancer.

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.

The Manager Process Development Nucleic Acids reports directly to the ATMF Head of Operations who in turn reports to the ATMF Project Lead. The Manager provides technical leadership and supervises staff executing process development research aligned through the ATMF Head of Operations to the ATMF Project addition this position will work closely with the Quality Assurance and Quality Control Managers to ensure process development activities meet quality and compliance expectations.

Work Performed
Project Management Resource Development and Strategic Planning:

- Leads the technical manufacturing strategy for nucleic acid therapeutics within ATMF setting direction for process development scale-up and sustainability in alignment with ATMFs broader operational and regulatory objectives.

- Develops process development workplans schedules and resource plans to ensure delivery against defined milestones risks and success criteria.

- Develops and manages the process development program budget including operational and equipment forecasting variance analysis and corrective recommendations to mitigate financial and delivery risk.

- Contributes to funding acquisition by assisting with grant writing and other initiatives.

Process Development and Management

- Leads the design validation and governance of ATMF bioprocessing workflows for a variety of advanced nucleic acid therapeutic products and/or ancillary materials for internal and external research partners; exercises independent technical authority over process selection and scale-up pathways in accordance with GMP requirements.

- Determines authorizes and maintains GMP-compliant upstream (synthesis transfection fermentation) and downstream (purification filtration formulation) manufacturing protocols; serves as the accountable authority for process robustness reproducibility and regulatory compliance.

- Leads the evaluation selection implementation and lifecycle oversight of specialized bioprocessing equipment; makes independent recommendations on facility suitability risk and capital investment implications for bioprocessing manufacturing.

- Establishes and governs the SOP framework for mass scale nucleic acid-product process development ensuring alignment with GMP standards.

Collaboration and Partnerships

- Acts as the technical authority for nucleic acid-product processes representing ATMF when communicating process development related recommendations and outcomes to senior leadership at UBC/ATMF senior policy makers of funding organizations and external partners to inform decision-making and strengthen the strategic success of ATMF research grant proposals projects and regulatory submissions.

- Leads technical consultation with UBC faculty and external clients to drive continual innovation scientific excellence and business development for the ATMF.

- Establishes technical alignment and best-practice integration with other academic GMP facilities across Canada and internationally to share knowledge and ensure ATMF meets evolving regulatory and industry standards.

- Prepares formal technical reports and presentations that document process performance regulatory readiness and project outcomes for stakeholders including funding agencies UBC and academic collaborators and industry partners as well as others as needed.

- Supports the development of collaborative workplans and technical components of research agreements / statements of work / collaborative proposals in coordination with ATMF leadership and relevant UBC support units (e.g. VP Research/finance/legal).

Technical Leadership and Innovation

- Provides direction (i.e. adoption validation and risk-mitigation) in the implementation of new nucleic acid technologies in the Process Development lab.

- Leads the transfer of nucleic acid-product activities to ATMFs GMP laboratories ensuring compliance with regulatory and quality requirements; holds stop-work authority where data integrity or compliance are at risk in process development activities.

- Develops and executes nucleic acid process development strategies that translate research into validated scalable GMP manufacturing processes while identifying internal and external synergies that enable new or expanded therapeutic development opportunities

- Develops phase appropriate process characterization plans to understand process drivers variability and scalability

- Leads troubleshooting and root cause analysis for process failures and variability; establishes preventive actions to improve robustness.

- Identifies and documents critical process parameters and material attributes and recommends control approaches aligned with intended product use and development stage.

Supervision and Training

- Defines technical roles in process development and associated competency requirements; evaluates performance against documented role-based expectations.

- Recruits trains and manages staff and trainees working on nucleic acid production in the Process Development lab.

- Fosters a collaborative and inclusive working environment that supports staff development and operational excellence

- Acts on behalf of ATMF as delegated/requested by the Head Operations and Lead AMTF Project.

- Provides support as required to the Head Operations and Lead AMTF Project.

Consequence of Error/Judgement
The incumbent will be expected to use professional judgement and initiative in the overall management of multiple work flows related to process development for nucleic acid manufacturing. Inappropriate judgement could damage the facilitys reputation amongst the research community and with industry partners which could directly affect the facility activities and growth potential. These outcomes could in turn negatively impact the reputation of the ATMF and UBC as a centre of research excellence. Failure to maintain compliance with the relevant regulatory 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. Errors in process design validation or execution may result in multi-million-dollar batch loss. Exercising poor judgment and failing to direct research team members can adversely affect the viability and validity of ATMFs projects or programs and may compromise UBCs ability to secure grant-based funding for future ATMF projects. The incumbent will work independently and will need to exercise a high degree of judgment and initiative in performing specialized duties and responsibilities. A lack of judgment could harm the team and organizations research and funding. Disseminating incorrect information would greatly impact the reputation of the Faculty and the University as a whole.

Supervision Received
This position works with wide latitude under the general supervision of the ATMF Head of Operations. Work is reviewed periodically to assess the validity of recommendations or the achievement of defined goals.

Supervision Given
Provides direction functional guidance and technical expertise to a team of researchers and technical staff. Manages staff and oversees day-to-day research responsibilities.

Minimum Qualifications
For research work a post-graduate degree or equivalent professional designation with a minimum of four years of related experience or an equivalent combination of education and experience. Otherwise an undergraduate degree in a relevant discipline is required with a minimum of six 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

• Experience with bioprocessing techniques and equipment for example bioreactors depth filtration chromatography tangential flow filtrations systems plasmid DNA production mRNA production LNP encapsulation and formulation.

• Strong analytical skills and experience with bioprocess design characterization and optimization.

• Experience in scaling up manufacturing processes from research to clinical-grade production.

• Ability to prepare clear concise and accurate research and technical reports and protocols.

• The successful candidate will be passionate self-driven independent thinking with excellent organizational oral and written communication and interpersonal skills as well as strong problem-solving skills. Demonstrated excellent managerial skills and experience in supervising personnel.

• Experience supervising personnel conducting research and/or bioprocessing activities.

• Familiarity with regulatory frameworks such as Health Canada FDA and EMA guidelines for biotherapeutic products.

• Knowledge of automation process control and high-throughput screening techniques.

• Experience working with LIMS electronic lab notebooks and data management systems.

• Ability to work a flexible schedule including occasional weekends evenings and early mornings as required.

• Ability to work both independently and collaboratively in a team environment.

• 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.

• Demonstrated ability to work in a fast-paced collaborative research environment.