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CMC Project Manager/Sr. CMC Project Manager

CMC Project Manager/Sr. CMC Project Manager

ID 
2018-1167
Category 
Other
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The CMC Project Manager/Sr. CMC Project Manager is the lead for one or more programs in the clinical development pipeline and is responsible for operational matrix management of the CMC development plan, which includes cross-functional activities in process development, manufacturing, quality and regulatory affairs.  This individual is also responsible for contract and alliance management with manufacturing outsourcing partners (cell banking, drug substance manufacturing, drug product manufacturing) to ensure completion of deliverables supporting MacroGenics’ clinical pipeline.

 

Responsibilities and Job Duties

  • Lead the cross-functional CMC team and ensure team focus and accountability to achieve goals, and act as the CMC representative accountable to the PDT for CMC aspects (strategic and operational) for projects within assigned product development programs.
  • Use standard PM tools to develop and maintain the integrated CMC plan (activities and timelines) using standard PM tools and ensure proper alignment with the overall project plan.  Monitor budget, deliverables and timelines per approved agreements/contracts, and communicate regular updates of program status via dashboards to internal and external stakeholders.
  • Liaise between company and external vendors to obtain vendor proposals/quotes for assigned manufacturing outsourcing projects and follow internal processes for timely approval and procurement of services.
  • Independently manage day to day project and/or team activities and issues; obtain management guidance for strategic or complex topics.
  • Collaborate with functional representatives to proactively anticipate and identify project risks and develop action and resolution plans.
  • Establish and maintain effective communication channels to provide accurate information to the CMT, functional line management, PDT and other governance bodies (internal and external) as required.
  • Manage logistics for and chair joint meetings with partners and vendors including proactive agenda development and meeting preparation.
  • Identify and implement best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.

Qualifications

Education

Bachelor’s in a relevant technical or scientific discipline  

 

Experience

CMC Project Manager

  • 5 years’ experience in biotech/pharma industry
  • 2 years prior experience managing projects
  • Direct experience in one or more areas of CMC biopharmaceutical product development (e.g. process development, technical services, GMP manufacturing)

Sr. CMC Project Manager

  • 8 years’ experience in biotech/pharma industry
  • 5 years prior experience managing projects
  • Direct experience in one or more areas of CMC biopharmaceutical product development (e.g. process development, technical services, GMP manufacturing)
  • Experience managing and leading teams

Knowledge, Skills and Abilities

  • Demonstrated understanding of project management principles applicable to bio/pharma
  • Demonstrated ability to balance scientific, technical and business objectives
  • Capable of concurrently and efficiently managing multiple projects
  • Well-organized with ability to effectively prioritize
  • Demonstrated leadership skills are required
  • Demonstrated ability to work with cross-functional teams in a matrix environment
  • Strong collaborative skills, ability to develop working relationships with colleagues at all levels of the organization
  • Strong written and verbal communication skills
  • Planning and monitoring skills with strong attention to detail including direct experience with project management tools and software

Supervisory Responsibilities

None

 

Preferred Qualifications

  • Professional project management certification
  • Experience in managing external partners (collaborators, CMOs)
  • Experience in the generation of regulatory filings (INDs and BLAs)

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.