Director, Manufacturing Science And Technology (MSAT)

Reports to: Senior Director, Process Sciences and Analytical Development

Responsibilities

MSAT

• Oversees the hiring, development, and performance management of staff within the MSAT team. Ensure the implementation of a highly effective team, responsible for supporting clinical and commercial production within a state-of-the art, multi-product, late stage, and commercial CGT facility.
• Accountable for resource allocation and project prioritization within the MSAT team. Recruits, directs, coaches, and develops talent in the team to maintain a high level of technical expertise in team members who work collaboratively with key partners.
• Leads the MSAT group to ensure the launch of OmniaBio’s Hamilton facility, including with commissioning, qualifying, and validating activities, as well as supporting ongoing GMP operations, including all technology transfer, process optimization, validation (process design, process qualification and continued process verification).
• Owns and is fully accountable to drive various department projects that aim to enhance continuous improvements, with a particular emphasis on the streamlined & efficient interactions between the Development and GMP Operations teams.
• Implements appropriate project and departmental metrics supporting the OmniaBio Operating Model as the modus operandi for the team.
• Represents MSAT within multiple complex customer-facing product project teams using a standard methodology/procedure to successfully transfer both existing and new technologies related to cell banking, upstream processing or downstream processing formulation and filling of GMP cell and vector manufacturing. Client programs can be at various stages of development, from early clinical phase through to late stage and final commercialization.
• Provides technical and thought leadership on industrialization for the various technical platforms within OmniaBio, with a particular focus on iPSCs, viral and non-viral gene modified immune cell therapies, cell banking, and other innovative technologies that arise from our internal development efforts.
• Builds and maintains systems to continuously monitor, analyze and optimize process performance and support and own quality events, including change controls, investigations, and corrective and preventative actions. Imbeds key skills for investigation of non-conformance and root cause derivation. Escalates anomalies and concerns using judgement as a seasoned leader.
• Ensures MSAT can effectively 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.
• Serves as a subject matter expert in client-facing scope discussions, developing internal business processes, authoring, and reviewing SOWs and helping to implement operational documents such as SOPs and work instructions, along with protocols and reports.
• Accountable for the introduction and support of qualification of new process technologies into GMP manufacturing, while managing technical risks associated with process transfer and GMP implementation of product and process; leading cross-functional teams to ensure relevant transfer; and communication of critical process and technical information such that successful outcomes are achieved.
• Collaborates and provides leadership within a 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-based risk assessment; and review and approval of production batch records.
• Designs and analyzes process fit and process-scale up in collaboration with vendors, customer technical experts, and OmniaBio/CCRM Process Development teams.
• Defines, reviews, and approves process-related documents (i.e., process overview, aseptic process simulation protocols, development/investigative protocols, and reports).
• Leads customer technical team meetings and serves as technical lead and subject matter expert at joint project team meetings.
• Establishes phase-appropriate and seamless process knowledge transfer from R&D/Process Development to clinical manufacturing, thereby achieving high manufacturing success rates and on-time regulatory approvals.

Operational

• Partners closely with Manufacturing Operations leadership team on 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 clients.
• Collaborates with the PS&AD, GMP Operations, Facility, Quality, and Supply Chain team, as well as external contractors and 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.
• Accountable for process validation, process performance qualification (PPQ), product licensure and registration preparation, as well as planning and execution of commercial supply.
• Contributes to authorship and review of relevant chemistry, manufacturing and control sections of clients’ regulatory dossiers IND, CTA, NDA, BLA, MAA, etc.
• Serves as a subject matter expert during internal and external audits.
• Drives health and safety performance, creates and maintains a safety-focused culture.
• Accountable for all aspects of the MSAT budget planning process, including capital equipment and material needs, staffing requirements, and contracted services requirements.
• Maintains an understanding of current industry trends and regulatory standards and participates in industry best practices.
• Represents MSAT in leadership forums.

General Management

• Provides regular updates of progress, successes, and challenges to senior management.
• Provides insight into business metrics associated with the GMP Operations business unit to identify and develop plans to improve efficiencies, optimize costs and increase productivity.
• Reviews and approve documents, including SOPs, batch records, material specifications, and validation protocols.
• Demonstrates 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.).
• Over 8-12 years of experience in cell therapy/viral development or manufacturing, or similar within the pharmaceutical, medical technologies, biologics, or related industries. A minimum of 6 years experience in a progressive manager/team leadership role.
• Experience in technical oversight of GMP manufacturing operations for a contract manufacturing organization, a third-party testing facility, or a biotechnology company performing similar activities.
• GMP 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

• Professional Engineer (P. Eng.) designation.
• Leadership experience of an MSAT team, ideally within the CGT industry, or a related biopharmaceutical modality
• Proven track record supporting either product development, technology transfer of GMP operations.
• Sound knowledge of applicable regulatory frameworks and requirements for CGT and regenerative medicine, such as GMP, 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 able to multitask and succeed in a team environment.
• Demonstrated initiative and able 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, PPQ protocols, etc.
• Experience in supporting sales and operations planning, and integrated business planning.
• Demonstrated ability to hire, coach and grow technical talent.

OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.