Scientific Lead, Manufacturing Science and Technology (MSAT)

OmniaBio

Hamilton

CAD 60,000 - 80,000

Job description

Job Title: Scientific Lead, Manufacturing Science and Technology (MSAT)

Reports to: Associate Director MSAT, Process Sciences and Analytical Development (PS&AD)

Position Summary:

As a Scientific Lead, MSAT, you will contribute in the support of cell and gene therapy cGMP activities, which include technology transfer, process optimization, and validation. Working closely with the Associate Director, MSAT and other PS&AD leaders, this position will also provide leadership and support to the identification, evaluation, sourcing, and maturation of new innovative technologies. The responsibilities of this role include providing technical leadership in client-facing projects and/or OmniaBio’s strategic projects, implementing the technology transfer processes and policies of our Hamilton facility, coordinating with the cross-functional team on the evaluation and translation of manufacturing processes, and assisting in establishing long term group direction and objectives.

Technology transfer into cGMP is a significant focus of this role, with programs ranging from internal transfer from our development teams to external transfers direct from client sites. You will ensure process scalability and manufacturability within our Hamilton facility.

While this is an independent contributor role, you will use your considerable experience and people-influencing skills to mentor other development and MSAT scientists/engineers to ensure operational & strategic roadmaps are effectively implemented. Through the planning, execution, and analysis of scale-down and at-scale experiments, this role develops the process understanding and training needed to support robust and high-quality manufacturing of a variety of modalities, including allogeneic and autologous cell therapy, viral vector and stem cell platforms. You will serve as a client-project lead and subject matter expert in client-facing discussions, overseeing the execution of project milestones and process-specific deliverables. You will also support the development of internal business processes, and draft SOPs, protocols, batch records, risk assessments, and reports. In addition, you will support the assessment of process-related deviations and drive continuous improvement efforts for manufacturing processes and business workflows. This position will directly contribute to the successful delivery of products in support of numerous clinical trials.

OmniaBio Overview:

OmniaBio Inc, a subsidiary of Toronto-based CCRM, is a contract development and manufacturing organization (CDMO) producing gene-modified cell therapies and viral vectors, compliant with cGMP standards. OmniaBio has support from the Government of Ontario, via the Invest Ontario Fund, and is the first project to be funded through the province’s Life Sciences Strategy. The facility will be built in phases and is expected to be the largest of its kind in Canada. OmniaBio will be Canada’s first commercial-scale CDMO dedicated to cell and gene therapies (CGTs). Located on the biomanufacturing campus at McMaster Innovation Park (Hamilton, ON), OmniaBio will catalyze life sciences careers and innovation in Canada while advancing pioneering medicine with the potential to cure, not just treat, many forms of cancer, cardiovascular diseases, Parkinson’s, and diabetes, amongst other diseases. OmniaBio will support a broad range of CGT companies globally, enabling Phase I to commercial-scale manufacturing.

Responsibilities:

MSAT

Provide project leadership across a variety of modalities and technical disciplines, with a focus on cell and immunotherapies, induced pluripotent stem cells (iPSCs), and lentiviral vectors platforms, with support to gene editing, cell banking, and other innovative platform technologies.
Support the introduction and qualification of new process technologies into cGMP manufacturing, while managing technical risks associated with process transfer. Lead cross-functional teams to ensure relevant transfer and communication of critical processes and technical risks such that successful outcomes are achieved.
Author and review technical documentation related manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
Maintain systems to continuously monitor, analyze, and optimize process performance and support and support Quality events, including change controls, investigations, and CAPAs. Imbedding key skills for investigation of non-conformance and root cause derivation. Escalating anomalies and concerns utilizing judgement as a seasoned leader.
Serve as a subject matter expert in client-facing discussions and leading technical discussions with the client to support the transfer of process knowledge and identification of mitigations, alternatives, and solutions to process-related issues.
Collaborate and provide leadership within cross-functional teams, including the client, Process Development, Manufacturing, and Project Management to ensure on-time delivery of technology transfer activities.
The activities include but are not limited to: performing process gap analysis; fit-to-plant; equipment and process characterization and scale-up; Failure Modes and Effects Analysis (FMEA)-based risk assessment; and drafting, review and approval of production batch records.
Support investigations and continuous improvement initiatives, including oversight of the planning, execution and analysis of experiments at the manufacturing scale and using qualified scale-down models, in collaboration with other experts within PS&AD and other technical business units as required.
Define, review and approve process-related documents (i.e., process overview, aseptic process simulation (APS) protocols, development/investigative protocols, and reports).
Establish phase-appropriate and seamless process knowledge transfer from R&D/PD to clinical manufacturing, thereby achieving high manufacturing success rates and on-time regulatory approvals.

Operational

Support the implementation of a production strategy for contract manufacturing services for cell therapy (autologous and allogeneic cell and gene therapies) and viral vector production for our clients
Work collaboratively with PS&AD, GMP Operations, Facility, Quality units, Supply Chain, External Contractors, Project Managers to develop scheduling windows within manufacturing operations with respect to facility maintenance, qualification of ongoing operations, periodic engineering projects, and product/process transfers.
Support process validation, process performance qualification (PPQ), product licensure and registration preparation as well as planning and execution of commercial supply.
Contribute to authorship and review of relevant CMC sections of our clients regulatory dossiers (IND, CTA, NDA, BLA, MAA etc.).
Maintain an understanding of current industry trends and regulatory standards and participate in industry best practices.

Support to Business Development

Assist Contract Services and Business Development teams to attract clients and finalize service agreements. Supporting the creation of client production budgets that align with current and future business objectives. This includes supporting the authorship of proposals, SOWs and other documentation as required by BD.
Represent the organization and promote its mission and capabilities to the CGT field through participation at conferences, symposia, other venues, and during customer visits.
Interface with academic and industry partners to ensure meaningful engagement and collaboration.

General Management

Provide regular updates of progress, successes, and challenges to senior management.
Provide insight into business metrics associated with the GMP Operations business unit to identify and develop plans to improve efficiencies, optimize costs and increase productivity.
Demonstrate the organization’s values of purpose, integrity, excellence, accountability, and collaboration, and motivate others to do the same.

Requirements:

PhD/M.Sc. degree in science (e.g., bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.).
Five-to-seven (5-7 years) or more years of experience in cell therapy/viral production, or similar within the pharmaceutical, medical technologies, biologics or related industries.
Experience in technical oversight of GMP manufacturing operations for Contract Manufacturing Organization (CMO), a third-party testing facility, or a biotechnology company performing similar activities.
cGMP manufacturing experience at a clinical or commercial scale.
Strong understanding of cell/gene therapy manufacturing processes and technologies.
Strong English as written and oral communication.

Desired Characteristics:

P. Eng degree
Sound knowledge of applicable regulatory frameworks and requirements for CGT and regenerative medicine, such as cGMP, ISO, or medical device development.
Experience with processing and scale-up of mammalian cells or similar
Demonstrated experience with bioprocess techniques with experience in bioreactors (either oscillating or stirred tank) and other equipment relevant to CGT.
Experience establishing customer-facing organizations and service models.
Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.
Demonstrated initiative and the ability to deliver high-quality outcomes.
Driven by understanding, meeting and exceeding customers’ expectations and requirements.
Takes a collaborative approach to working with cross-functional teams, with good multicultural awareness.
Experience authoring and/or reviewing validation master plans, process validation plans, process performance qualification (PPQ) protocols, etc.
Experience in supporting sales and operations planning, and integrated business planning.
Demonstrated ability to hire, coach and grow technical talent.