Director, CMC Lead Drug Development (Hyperimmunes)

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Director, CMC Lead Drug Development (Hyperimmunes)

Location:

Winnipeg, MB, CA, R3T 5Y3

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed to protect life.

The CMC Lead – Drug Development Hyperimmunes is responsible for establishing the CMC development plan, working with cross-functional experts, and leading the execution of the plan for drug substance and drug products from pre-clinical through commercial development, including lifecycle management. This role is a key leadership function in the development of therapeutic candidates and advancement of platforms, combined with the introduction of new candidates and technology enhancements for programs within Emergent. The role will deliver on all CMC aspects of a specific project, working both internally, across Emergent’s global locations, and externally with partners, contractors and government agencies, to fulfill drug development stages up to and including:

1. the coordination of drug substance (upstream & downstream), drug product, and associated analytical development activities through a lead intermediary.

The activities may be performed by partners, contractors, or company personnel at various global locations. The role requires proficiency in advancing the development of our portfolio of products and product candidates with an ability to oversee programs from the completion of product feasibility through process and product development, scale-up and registration in commercial manufacture, and lifecycle management for continued product expansion, improvement, and cost efficiencies. This position has a focus on Emergent’s hyperimmune product portfolio, expertise in this industry area, technology and product usage is critical to individual and organizational success. These programs may be a mix of early-stage proof of concept, through IND, late stage, through regulatory approvals, as well as life cycle management programs that require flawless execution because they are critical to commercial success. The role requires strong project coordination and communication skills along with skills in presentation, and leadership, process design, technology transfer, and production of biologics drug supplies along with lifecycle support.

I. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• This role works cross-functionally to develop strategies, set direction, plan, and prioritize initiatives that lead to the advancement of our project portfolio. This includes the integration of the work priorities with other groups internal and external to the organization; Effective communication on such initiatives with senior leaders, peers, staff, and external stakeholders.
• Leads cross-functional efforts that manage third-party logistics production delivery and relationships for the project portfolio. Select third-party manufacturers working with Quality and Regulatory, negotiate effective technical agreements, and identify contract analytical laboratory sites through development to commercialization stages.
• Resource planning including budget and staffing model preparation (for departments, functions, or systems) and capacity monitoring of routine operations and enhancement projects.
• Manage (in-person or remotely) ongoing development programs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt. as may be required by internal governance demands.
• Prepare, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND and NDA filings for the products that they manage.
• Develop, set, and communicate sustainable targets and goals for self and programs.
• Ensure the technology transfer of developed processes to external Contract Manufacturing Organizations (CMO) for GMP clinical manufacturing or additional as may be required.
• Be a key member in delivering the company’s product portfolio, including participation in the planning of timelines, deliverables, and milestones in collaboration with other cross-functional groups.
• Work closely with the Grants & Contracts team to respond to RFPs and win external funding as may be required.

BEHAVIORS:

To perform the job successfully, an individual should demonstrate the following competencies:

• Leadership – Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Inspires respect and trust; Accepts feedback from others; Provides vision and inspiration to peers and subordinates; Gives appropriate recognition to others.
• Managing across reporting structure – Includes personnel in planning, decision-making, facilitating and process improvements; Takes responsibility for team members’ activities; Develops team members’ skills and encourages growth; Fosters quality focus in others; Sets expectations and monitors delegates activities; Provides recognition for results. The role places a heavy reliance on the incumbents influencing skills across a range of functions for successful project delivery.
• Problem Solving – Identifies and resolves problems in a timely manner, analyzing information skillfully; Develops alternative solutions; Uses reason even when dealing with emotional topics.
• Interpersonal – Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’