Technical Program Manager

The Technical Program Manager reports to the VP, Technical Operations and is responsible for effectively working with the cross functional program teams, leading project execution for Biora's programs. This role is key in instilling both technical and project management discipline, quality and best practices across all functions of the BioJet program.

The successful candidate is responsible for leading the core team, progressing the project forward, establishing the project plan, timelines, design and data reviews, and driving decision making at critical milestones. As a Technical Program Manager, this individual is expected to facilitate the development and completion of design control documents, integrating these activities and deliverables into the project plan.

Responsibilities

This list is not all inclusive and may be expanded to include other responsibilities, as deemed necessary.
Facilitate detailed project planning and timeline development to ensure product development alignment to corporate goals
Ensure that design controls and risk management activities, deliverables, and processes are integrated into the project plans and timelines
Lead cross-functional project team meetings, publish minutes, and drive accountability and ownership across the core team
Document and manage roles and responsibilities within the cross-functional project team
Ensure that product and system-level requirements are established, integrated, verified, and validated as part of the project plan and timeline
Drive resource management and task allocation at each stage of development, working with department managers to resolve conflicts and priorities
Work with the Quality organization to ensure that compliance is met for project and design history file documents
Proactively drive functional planning and project risk management, ensuring alignment and unified cadence to meet the project milestones; establish and publish project dashboards and KPIs
Ensure the implementation of new standards on requirements and specifications development, management, and traceability on projects (e.g. requirements flow-down, capabilities flow-up, CTQs)

Education & Experience
Bachelor's degree in an engineering discipline or equivalent training
8+ years' direct related experience in managing projects in an FDA-regulated industry
5+ years' experience in the medical device product development of Class II or III devices; combination products is preferred
Advanced knowledge and experienced in the practical implementation and integration of FDA 820 CFR and ISO 13485 in device development planning and execution
Experience with design controls, risk management, and product realization
Experience managing projects from discovery to clinical trials and launch
Experience managing projects utilizing an IND regulatory and commercialization pathway; knowledge of regulatory requirements for medical device development preferred

Capabilities
Strong presentation skills with the ability to clearly communicate key project risks, milestones, and KPIs
Strong technical background and understanding of engineering principles, methodologies and how they translate into a project plan
Proficiency in at least one product development lifecycle methodology
Ability to maintain a collaborative and cooperative project team of both internal and external stakeholders; creativity in resolving issues to keep the project moving forward
Experience in establishing technical documentation and design control deliverables
Advanced proficiency in the use of timeline applications such as SmartSheet, MS Project, Timeline Pro+
Advanced proficiency in standard applications such as Microsoft Office (i.e., Word, Excel, PowerPoint), Visio

About Biora Therapeutics

Biora Therapeutics is developing the first swallowable autoinjector. Biora's BioJet platform for oral delivery of macromolecules is designed to replace injection with needle-free oral delivery, using an ingestible capsule that uses liquid jet injection to deliver drug into the submucosa of the small intestine.

The BioJet platform is designed to autonomously deliver a wide range of molecules, including proteins, peptides, and nucleic acids. The BioJet ingestible injectable device delivers standard liquid drug formulations with a capacity of >300 microliters and the ability to deliver doses greater than 50 milligrams.

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