Director, Drug Product SME, CMC

Company: Emergent BioSolutions
Location: Gaithersburg
Posted on: March 15, 2025

Job Description:

Select how often (in days) to receive an alert:We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed to protect and enhance life.I. JOB SUMMARYThe Director, Drug Product SME is responsible for providing key expertise and strategic contributions to the CMC Drug Development team to establish the CMC development plan and support its execution from pre-clinical through post-approval commercial stages. This is a key position in the monoclonal antibody, hyperimmune, and vaccine CMC team.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.II. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• This role provides drug product expertise in monoclonal antibodies, hyperimmunes and vaccines to multiple programs, and may involve interactions and collaboration with internal and external teams, to support 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 requires strong skills in communication, presentation, and technical areas, process design, technology transfer, and production of biologics drug supplies along with lifecycle support. Effective communication is required for interactions with senior leaders, peers, and both internal and external personnel.
• This role works with the CMC team to develop strategies, set direction, and plan initiatives that lead to the advancement of our project portfolio.
• Supports cross-functional efforts that manage third-party logistics production, delivery and relationships for the project portfolio. Support sourcing and selection of third-party manufacturers.
• Supports resource planning including budget and staffing model needs for individual program initiatives.
• Participate in (in-person or remotely) ongoing development programs including developing detailed technical work plans; selecting suitable service for the various activities; management of vendor performance, and preparing periodic updates for Sr. Mgmt. as may be required by internal governance demands.
• Prepare, in conjunction with functional leaders and Regulatory Affairs, the Chemistry and Manufacturing Controls sections of IND and NDA filings for the products that they support.
• Develop, set, and communicate sustainable targets and goals for self and programs.
• 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, where 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.
• 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
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Keywords: Emergent BioSolutions, Washington DC , Director, Drug Product SME, CMC, Executive , Gaithersburg, DC