Scientific Lead, Manufacturing Science and Technology (MSAT) bei OmniaBio
OmniaBio · Hamilton, Kanada · Onsite
- Senior
- Optionales Büro in Hamilton
Position Summary
As a Scientific Lead, MSAT, you will oversee cell and gene therapy Good Manufacturing Practices (GMP) Manufacturing Science and Technology (MSAT) activities, which include technology transfer, process optimization and validation. 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 the following: providing technical leadership in client-facing projects and/or OmniaBio’s strategic projects; establishing technology transfer processes and policies; promoting manufacturing operations interactions; providing technical input and guiding manufacturing strategy; coaching and mentoring employees; prioritizing work; and, assisting in establishing long-term group direction and objectives. The focus of this role is to lead a team of MSAT Scientists and Associate Scientists who are supporting allogeneic cell and gene modified cell therapy product manufacturing processes through the planning, execution and analysis of at-scale and scale-down experiments to enhance process understanding and performance. You will serve as a subject-matter expert in client-facing scope discussions, developing internal business processes, and writing standard operating procedures (SOPs), along with protocols and reports. This position will directly contribute to the successful delivery of products in support of numerous clinical trials.
As a leader of the MSAT Team, you are responsible for the successful transfer of processes into production. As such, you are in direct contact with our clients and process development (PD) scientists. You ensure process scalability and manufacturability. In addition, you will coordinate all process relevant major deviations and process adaptations and you are responsible for continuous improvement of the manufacturing processes.
Responsibilities
MSAT
- Provide leadership and build a strong technical MSAT team supporting clinical and/or commercial manufacturing.
- Represent MSAT within multiple complex customer-facing product project teams using a standard methodology/procedure to successfully transfer both existing and new technologies either into upstream processing (UPS) or downstream processing (DSP) of GMP cell and vector manufacturing from development through MSAT pilot scale.
- Provide leadership with a focus on induced pluripotent stem cells (iPSCs), gene editing, cell banking, CAR-NKs and other innovative platform technologies and 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.
- Provide general and technical supervision to a group of MSAT Scientists and Associate Scientists whose responsibility it is to process technology transfer of cell and gene therapy (CGT) product manufacturing processes.
- Author and review technical documentation related to manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions and product impact assessments.
- Be accountable for the introduction and support of qualification of new process technologies into cGMP manufacturing, while managing technical risks associated with process transfer; leading cross-functional teams to ensure relevant transfer; and communication of critical process and technical information such that successful outcomes are achieved.
- Collaborate with 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, review and approval of production batch records.
- Review client manufacturing processes or SOPs, Bill of Equipment and Bill of materials for GMP manufacturing compliance.
- Design and analyze process fit and process-scale up in collaboration with vendors, customer technical experts or OmniaBio’s Process Development teams.
- Define, review and approve process-related documents (i.e., process overview, aseptic process simulation (APS) protocols, development/investigative protocols, and reports).
- Lead customer technical team meetings and serve as technical lead and SME at joint project team meetings.
- Provide technical leadership and support to cross-functional project teams in areas of process tech transfer, process design and scale up, facility fit, gap analysis, FMEA risk assessment, troubleshooting and investigation.
- Lead the allogenic platform team in supporting manufacturing when troubleshooting processes on the manufacturing floor and during post-operational investigations.
- 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
- Create, refine and implement, with the assistance of Director, MSAT, a tech transfer and production strategy for contract manufacturing services for cell therapy and gene modified cell-based production for industry and academic clients.
- Manage a medium-size group of scientists whose major responsibility is to process technology transfer from PD or clients to GMP production.
- Build cross-functional relationships with other internal and external stakeholders, including, but not limited to, Process Development, Operations, Quality units, Supply Chain and Facilities.
- Serve as a subject-matter expert during internal and external audits.
- Lead process validation, process performance qualification (PPQ) and commercial campaign preparation.
Support to Business Development
- Assist Contract Services and Business Development teams to attract clients and finalize service agreements.
- Provide tours of the Toronto facility to potential clients, with the purpose of promoting collaboration, technology partnership, manufacturing agreements and network/relationship building.
- 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
- Responsible for resource allocation and project prioritization. Recruit, direct, coach and develop talent in the MSAT team to maintain a high level of technical expertise that works collaboratively with key partners.
- Lead the budget planning process, including capital equipment and material needs, staffing requirements, and contracted services requirements.
- Provide regular updates of progress, successes and challenges to the Director, MSAT and other executives.
- Provide insight into business metrics associated with the Deliver business unit to identify and develop plans to improve efficiencies, optimize costs and increase productivity.
- Review and approve documents, including SOPs, batch records, material specifications, and validation protocols.
- 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 (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.).
- Four plus 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.
- Must be able to travel domestically and internationally up to 10 per cent of the time.
Desired Characteristics
- 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 or demonstrated experience with bioprocess techniques with experience in bioreactors (either oscillating or stirred tank) as well as 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.
- Leads by example by proactively identifying problems and areas of improvement.
- 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.
