Director, CMC Project Management

Gaithersburg, MD, US
Nov 26, 2020
Required Education
Bachelors Degree
Position Type
Full time
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.

Reporting to the Vice President of Project Management, this role will be a part of the Project Management Organization's Leadership Team and will be responsible for directing the manufacturing side of business unit operations. The director will lead a team of direct reports and must be capable of working collaboratively with leaders from various functions (Clinical, Regulatory, Quality, etc.) to successfully drive manufacturing operations and meet aggressive timelines and budgets. The successful candidate must be able to work independently, multi-task, and communicate effectively with all levels of the organization.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Provide oversight of the Vaccine Business Unit's Chemistry, Manufacturing and Control (CMC) operations including:
    • Driving the strategy behind manufacturing processes, defining product characteristics, ensuring that product testing is appropriately designed and executed, and evaluating stability programs
    • Directing the process of manufacturing vaccines from early-stage to late-stage clinical development, and through to commercial scale. Identify and implement new capabilities and processes to further align development and commercial operations and manufacturing
    • Lead the execution of manufacturing plans with matrix functions and manufacturing operations groups at multiple sites. Work with site project management for delivering on timelines and budgets.
    • Lead a team of Vaccine Business Unit project management professionals in planning activities including comprehensive project timelines, multi-year resource forecasts, and project risk plans
    • As part of the PMO leadership team, help build and maintain an infrastructure with long-term capability to support future growth throughout the business unit Identify and resolve gaps/conflicts with function resources
    • Act as the manufacturing expert for the BU in evaluating new business opportunities
    • Understand business unit portfolio / project priorities, and drive project progress accordingly

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

• BA/BS degree required, advanced scientific degree or MBA a plus
• 8 years of experience within Project Management, or equivalent work experience.
• Prior experience in manufacturing of biologics required
• The ideal candidate will have in-depth understanding of project management systems and processes, the interdependencies of development activities and projects, and the regulatory requirements for product registration.
• Excellent management and communication skills, including expert prioritization, team building and the ability to synthesize project management for corporate leadership.
• Exceptional leadership skills and proven ability to interact effectively with all levels of the organization.
• Highly developed diplomatic negotiation, interpersonal, and communication skills and the ability to influence without formal authority.
• Excellent analytical skills and experience developing and managing strategic business plans.
• Proven ability to manage and execute projects on time and within budget
• PM certification preferred
• Able to implement Earned Value Management techniques and provide earned value metrics in monthly reporting on government contracts a plus
• Proficiency in Word, Excel, PowerPoint and Project is required
• Able to travel as required to meet with contractors, partners, or project funding entities

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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