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
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